A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04622319 |
Recruitment Status :
Recruiting
First Posted : November 9, 2020
Last Update Posted : April 9, 2021
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Condition or disease | Intervention/treatment | Phase |
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HER2-Positive Primary Breast Cancer Residual Invasive Breast Cancer | Drug: DS-8201a Drug: T-DM1 | Phase 3 |
This study will examine trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary BC who have residual invasive disease in breast or axillary lymph nodes with higher risk of recurrence, which includes patients who were inoperable at disease presentation or had pathological node-positive status after neoadjuvant therapy.
The primary objective is to compare invasive disease-free survival (IDFS) between T-DXd and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS).
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1600 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05) |
Actual Study Start Date : | December 4, 2020 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | September 1, 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: Trastuzumab deruxtecan (T-DXd)
Participants who will be randomized to receive trastuzumab deruxtecan (T-DXd) at a starting dose of 5.4 mg/kg.
|
Drug: DS-8201a
Administered initially as an intravenous (IV) infusion at a dose of 5.4 mg/kg on Day 1 of each 21-day cycle
Other Name: Trastuzumab deruxtecan (T-DXd) |
Active Comparator: Trastuzumab ematansine (T-DM1)
Participants who will be randomized to receive trastuzumab ematansine (T-DM1) at a starting dose of 3.6 mg/kg.
|
Drug: T-DM1
Administered initially as an intravenous (IV) infusion at a dose of 3.6 mg/kg on Day 1 of each 21-day cycle
Other Name: Trastuzumab emtansine (T-DM1) |
- Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment [ Time Frame: Randomization to date of invasive local, axillary or distant recurrence, invasive contralateral breast cancer or death from any cause (whichever occurs first), up to approximately 81 months postdose ]
- Disease-free Survival (DFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment [ Time Frame: Randomization to date of the first occurrence of an IDFS event including second primary non-breast cancer event or contralateral or ipsilateral ductal carcinoma in situ (whichever occurs first), up to approximately 81 months postdose ]
- Overall Survival (OS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment [ Time Frame: Randomization to date of death from any cause, up to approximately 81 months postdose ]
- Distant Recurrence-free Interval (DRFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment [ Time Frame: Randomization to date of distant recurrence, up to approximately 81 months postdose ]
- Brain Metastases-free Interval (BMFI) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment [ Time Frame: Randomization to date of brain metastasis, up to approximately 81 months postdose ]
- Percentage of Treatment-emergent Adverse Events in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment [ Time Frame: Baseline up to approximately 81 months postdose ]
- Serum Concentrations of Trastuzumab Deruxtecan (T-DXd), total anti-HER2 antibody, and Active Metabolite MAAA-1181a [ Time Frame: Pre-dose on Day 1 of Cycles 1, 4 and 10 and within 15 minutes post-dose on Day 1 of Cycles 1 and 4 (each cycle is 21 days) ]
- Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) [ Time Frame: Baseline up to approximately 81 months postdose ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Adults ≥18 years old (local regulatory requirements will apply if the legal age of consent for study participation is >18 years old)
-
Pathologically documented HER2-positive breast cancer (BC):
- HER2-positive expression defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) confirmed prior to study randomization
- Histologically confirmed invasive breast carcinoma
- Clinical stage at disease presentation: T1-4, N0-3, M0; patients presenting with T1N0 tumors are not eligible
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Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting one of the following high-risk criteria:
- Inoperable breast cancer at presentation (prior to neoadjuvant therapy), defined as clinical stages T4, N0-3, M0 or T1-3, N2-3, M0
- Operable at presentation, defined as clinical stages T1-3,N0-1,M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy
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Completion of neoadjuvant systemic chemotherapy, including taxane and HER2-directed treatment prior to surgery
- Systemic therapy must consist of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab (± pertuzumab) and at least 9 weeks of taxane based chemotherapy. Patients may have received an anthracycline as part of neoadjuvant therapy in addition to taxane chemotherapy.
- Adequate excision as confirmed per medical records: surgical removal of all clinically evident disease in the breast and lymph nodes.
- An interval of no more than 12 weeks between the date of last surgery and the date of randomization.
- Known hormone receptor (HR) status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR positive status defined by either positive estrogen receptor (ER) and/or positive progesterone receptor (PR) status. HR-negative status defined by both known negative ER and known negative PR.
- Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
- Has adequate organ function within 14 days before randomization.
Key Exclusion Criteria:
- Stage IV (metastatic) BC
- History of any prior (ipsi- or contralateral) breast cancer except lobular carcinoma in situ (LCIS)
- Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery
- Prior treatment with T-DXd, T-DM1 or other anti-HER2 antibody-drug conjugate (ADC)
-
History of exposure to the following cumulative doses of anthracyclines:
- Doxorubicin > 240 mg/m^2
- Epirubicin or Liposomal Doxorubicin-Hydrochloride > 480 mg/m^2
- For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m^2
- History of other malignancy within the last 5 years except for appropriately treated CIS of the cervix, nonmelanoma skin carcinoma, Stage I melanoma skin carcinoma, Stage I uterine cancer, or other appropriately treated non-breast malignancies
- History of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids and/or has ILD/pneumonitis noted on computed tomography (CT) scan of the chest at Screening (asymptomatic interstitial changes confined to recent radiation therapy fields are not excluded)
- Known pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months prior to randomization, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease).
- Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior lobectomy or pneumonectomy
- Medical history of myocardial infarction (MI) within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer 28 days prior to randomization

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622319
Contact: Daiichi Sankyo Contact for Clinical Trial Information | 908-992-6400 | CTRinfo@dsi.com | |
Contact: (Asia sites) Daiichi Sankyo Contact for Clinical Trial Information | +81-3-6225-1111(M-F 9-5 JST) | dsclinicaltrial@daiichisankyo.co.jp |


United States, California | |
The Oncology Institute of Hope & Innovation | Not yet recruiting |
Anaheim, California, United States, 92801 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Anaheim, California, United States, 92806 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Baldwin Park, California, United States, 91706 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Bellflower, California, United States, 90706 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Fontana, California, United States, 92335 | |
Contact: Principal Investigator | |
Orange Coast Blood and Cancer Care | Not yet recruiting |
Fountain Valley, California, United States, 92708 | |
Contact: Principal Investigator | |
Orange Coast Memorial Med Ctr | Not yet recruiting |
Fountain Valley, California, United States, 92708 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Harbor City, California, United States, 90710 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Irvine, California, United States, 92618 | |
Contact: Principal Investigator | |
Long Beach Memorial TCI | Not yet recruiting |
Long Beach, California, United States, 90806 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Panorama City, California, United States, 91402 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Riverside, California, United States, 92505 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
San Diego, California, United States, 92120 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
San Marcos, California, United States, 92078 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
West Los Angeles, California, United States, 90034 | |
Contact: Principal Investigator | |
Kaiser Permanente | Not yet recruiting |
Woodland Hills, California, United States, 91367 | |
Contact: Principal Investigator | |
United States, Florida | |
Baptist MD Anderson Cancer Center | Not yet recruiting |
Jacksonville, Florida, United States, 32207 | |
Contact: Principal Investigator | |
Orlando Health | Not yet recruiting |
Orlando, Florida, United States, 32806 | |
Contact: Principal Investigator | |
United States, Illinois | |
Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center | Not yet recruiting |
Elmhurst, Illinois, United States, 60126 | |
Contact: Principal Investigator | |
Edward Cancer Center | Not yet recruiting |
Naperville, Illinois, United States, 60540 | |
Contact: Principal Investigator | |
Illinois CancerCare | Not yet recruiting |
Peoria, Illinois, United States, 61615 | |
Contact: Principal Investigator | |
Edward Cancer Center Plainfield | Not yet recruiting |
Plainfield, Illinois, United States, 60585 | |
Contact: Principal Investigator | |
United States, Kentucky | |
University of Kentucky, Markey Cancer Center, Clinical Research Organization | Not yet recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: Principal Investigator | |
Baptist Health Louisville | Not yet recruiting |
Louisville, Kentucky, United States, 40207 | |
Contact: Principal Investigator | |
United States, Louisiana | |
LSU Health Baton Rouge North Clinic | Not yet recruiting |
Baton Rouge, Louisiana, United States, 70805 | |
Contact: Principal Investigator | |
Mary Bird Perkins Cancer Center | Not yet recruiting |
Baton Rouge, Louisiana, United States, 70809 | |
Contact: Principal Investigator | |
Our Lady of the Lake Physician Group | Not yet recruiting |
Baton Rouge, Louisiana, United States, 70817 | |
Contact: Principal Investigator | |
Ochsner Hematology Oncology North Shore - Covington (West Region) | Not yet recruiting |
Covington, Louisiana, United States, 70433 | |
Contact: Principal Investigator | |
Ochsner Clinic Foundation | Not yet recruiting |
New Orleans, Louisiana, United States, 70121 | |
Contact: Principal Investigator | |
United States, Maryland | |
Mercy Medical Center | Not yet recruiting |
Baltimore, Maryland, United States, 21202 | |
Contact: Principal Investigator | |
MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute | Not yet recruiting |
Baltimore, Maryland, United States, 21237 | |
Contact: Principal Investigator | |
MedStar Franklin Square Cancer Center at Loch Raven Campus | Not yet recruiting |
Baltimore, Maryland, United States, 21239 | |
Contact: Principal Investigator | |
Richard A. Henson Cancer Institute Ocean Pines | Not yet recruiting |
Berlin, Maryland, United States, 21811 | |
Contact: Principal Investigator | |
Frederick Health-James M Stockman Cancer Center | Not yet recruiting |
Frederick, Maryland, United States, 21702 | |
Contact: Principal Investigator | |
Peninsula Regional Medical Center | Not yet recruiting |
Salisbury, Maryland, United States, 21801 | |
Contact: Principal Investigator | |
Maryland Oncology Hematology | Not yet recruiting |
Silver Spring, Maryland, United States, 20904 | |
Contact: Principal Investigator | |
Holy Cross Hospital | Not yet recruiting |
Silver Spring, Maryland, United States, 20910 | |
Contact: Principal Investigator | |
United States, New York | |
Montefiore Medical Center | Not yet recruiting |
Bronx, New York, United States, 10461 | |
Contact: Principal Investigator | |
United States, North Carolina | |
Waverly Hematology Oncology | Recruiting |
Cary, North Carolina, United States, 27518 | |
Contact: Principal Investigator | |
Levine Cancer Inst Pineville | Not yet recruiting |
Charlotte, North Carolina, United States, 28210 | |
Contact: Principal Investigator | |
Levince Cancer Institute | Not yet recruiting |
Charlotte, North Carolina, United States, 28277 | |
Contact: Principal Investigator | |
Carolinas Medical Center Northeast | Not yet recruiting |
Concord, North Carolina, United States, 28025 | |
Contact: Principal Investigator | |
UNC REX Cancer Center | Not yet recruiting |
Raleigh, North Carolina, United States, 27607 | |
Contact: Principal Investigator | |
UNC REX Cancer Center of Wakefield | Not yet recruiting |
Raleigh, North Carolina, United States, 27614 | |
Contact: Principal Investigator | |
UNC Cancer Care at Nash | Not yet recruiting |
Rocky Mount, North Carolina, United States, 27804 | |
Contact: Principal Investigator | |
Wake Forest Baptist Medical Center | Not yet recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Principal Investigator | |
United States, Ohio | |
Cleveland Clinic | Not yet recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Principal Investigator | |
United States, Oregon | |
Kaiser Permanente Northwest--Oncology | Not yet recruiting |
Portland, Oregon, United States, 97015 | |
Contact: Principal Investigator | |
United States, Pennsylvania | |
AHN Cancer Insititute at Jefferson | Not yet recruiting |
Jefferson Hills, Pennsylvania, United States, 15025 | |
Contact: Principal Investigator | |
AHN Cancer Institute at Forbes | Not yet recruiting |
Monroeville, Pennsylvania, United States, 15146 | |
Contact: Principal Investigator | |
Allegheny General Hospital | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15212 | |
Contact: Principal Investigator | |
Magee | Not yet recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Principal Investigator | |
Reading Hospital, McGlinn Cancer Institute | Recruiting |
West Reading, Pennsylvania, United States, 19611 | |
Contact: Principal Investigator | |
United States, Rhode Island | |
Women & Infants Hospital of RI | Not yet recruiting |
Providence, Rhode Island, United States, 02905 | |
Contact: Principal Investigator | |
United States, Tennessee | |
Regional Cancer Center at Indian Path Community Hospital | Not yet recruiting |
Kingsport, Tennessee, United States, 37660 | |
Contact: Principal Investigator | |
Tennessee Oncology Nashville / Sarah Cannon | Not yet recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Principal Investigator | |
United States, Texas | |
Houston Methodist | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: Principal Investigator | |
Houston Methodist Willowbrook | Not yet recruiting |
Houston, Texas, United States, 77070 | |
Contact: Principal Investigator | |
Houston Methodist Sugarland | Not yet recruiting |
Sugar Land, Texas, United States, 77479 | |
Contact: Principal Investigator | |
United States, Virginia | |
Wellmont Medical Associates Oncology & Hematology | Not yet recruiting |
Bristol, Virginia, United States, 24201 | |
Contact: Principal Investigator | |
University of Virginia | Not yet recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Principal Investigator | |
Centra Lynchburg Hematology Oncology | Not yet recruiting |
Lynchburg, Virginia, United States, 24501 | |
Contact: Principal Investigator | |
Virginia Commonwealth University Massey Cancer Center | Not yet recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Principal Investigator | |
United States, Washington | |
MultiCare Institute for Research & Innovation | Not yet recruiting |
Spokane, Washington, United States, 99204 | |
Contact: Principal Investigator | |
MultiCare Institute for Research & Innovation | Not yet recruiting |
Spokane, Washington, United States, 99216 | |
Contact: Principal Investigator | |
MultiCare Institute for Research & Innovation | Not yet recruiting |
Spokane, Washington, United States, 99218 | |
Contact: Principal Investigator | |
United States, West Virginia | |
West Virginia University | Not yet recruiting |
Morgantown, West Virginia, United States, 26506 | |
Contact: Principal Investigator | |
Argentina | |
Centro Oncologico Riojano Integral | Not yet recruiting |
Capital, La Rioja, Argentina, 5300 | |
Contact: Principal Investigator | |
Sanatorio Británico de Rosario | Not yet recruiting |
Rosario, Santa Fe, Argentina, 2000 | |
Contact: Principal Investigator | |
Instituto de Oncología de Rosario | Not yet recruiting |
Rosario, Santa Fe, Argentina, S2000KZE, 2457 | |
Contact: Principal Investigator | |
COIBA | Not yet recruiting |
Buenos Aires, Argentina, B1884BBF | |
Contact: Principal Investigator | |
Hospital Aleman | Not yet recruiting |
Buenos Aires, Argentina, C1118 AAT | |
Contact: Principal Investigator | |
Instituto Alexander Fleming | Not yet recruiting |
Caba, Argentina, 1426 | |
Contact: Principal Investigator | |
CER San Juan | Not yet recruiting |
San Juan, Argentina, 5400 | |
Contact: Principal Investigator | |
Australia | |
Royal Adelaide Hospital | Not yet recruiting |
Adelaide, Australia, 5000 | |
Contact: Principal Investigator | |
Chris O Brien Lifehouse | Not yet recruiting |
Camperdown, Australia, 2050 | |
Contact: Principal Investigator | |
Monash Health | Recruiting |
Clayton, Australia, 3168 | |
Contact: Principal Investigator | |
Austin Hospital- Olivia Newto-John Cancer and Wellness Centre | Recruiting |
Heidelberg, Australia, 3804 | |
Contact: Principal Investigator | |
Peter MacCallum Cancer Centre | Recruiting |
Melbourne, Australia, 3000 | |
Contact: Principal Investigator | |
Breast Cancer Research Centre - WA | Recruiting |
Nedlands, Australia, 6009 | |
Contact: Principal Investigator | |
Genesis Care Northern Cancer | Recruiting |
Saint Leonards, Australia, 2065 | |
Contact: Principal Investigator | |
St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC) | Recruiting |
Subiaco, Australia, 2050 | |
Contact: Principal Investigator | |
Southern Medical Day Care Centre | Recruiting |
Wollongong, Australia, 2500 | |
Contact: Principal Investigator | |
Belgium | |
Antwerp University Hospital | Not yet recruiting |
Edegem, Antwerpen, Belgium, 2650 | |
Contact: Principal Investigator | |
UZ Gent | Not yet recruiting |
Gent, O. Vl., Belgium, 9000 | |
Contact: Principal Investigator | |
Algemeen Ziekenhuis AZ Klina - Borstkliniek | Not yet recruiting |
Brasschaat, Belgium, 2930 | |
Contact: Principal Investigator | |
Institut Jules Bordet Brussels Belgium | Not yet recruiting |
Brussels, Belgium, 1000 | |
Contact: Principal Investigator | |
Cliniques Universitaires Saint-Luc | Not yet recruiting |
Brussels, Belgium, 1200 | |
Contact: Principal Investigator | |
UZ Leuven - Campus Gasthuisberg | Not yet recruiting |
Leuven, Belgium, 3000 | |
Contact: Principal Investigator | |
CHU Liege | Not yet recruiting |
Liège, Belgium, 4000 | |
Contact: Principal Investigator | |
GZA Hospitals Campus Sint- Augustinus | Not yet recruiting |
Wilrijk, Belgium, 2610 | |
Contact: Principal Investigator | |
Brazil | |
Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia | Not yet recruiting |
Brasília, Federal District, Brazil, 70200-730 | |
Contact: Principal Investigator | |
Hospital Erasto Gaertner | Not yet recruiting |
Curitiba, Parana, Brazil, 81520-060 | |
Contact: Principal Investigator | |
Fundação Universidade de Caxias do Sul | Not yet recruiting |
Caxias Do Sul, Rio Grande Do Sul, Brazil, 95070-560 | |
Contact: Principal Investigator | |
Hospital Sao Lucas PUCRS | Not yet recruiting |
Porto Alegre, RS, Brazil, 90610-000 | |
Contact: Principal Investigator | |
Fundacao Pio XII-Hospital de Cancer de Barretos | Not yet recruiting |
Barretos, SP, Brazil, 14784-400 | |
Contact: Principal Investigator | |
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia | Not yet recruiting |
Santo André, SP, Brazil, 09060-650 | |
Contact: Principal Investigator | |
Hospital de Base de Sao Jose do Rio Preto | Not yet recruiting |
São José Do Rio Preto, SP, Brazil, 15092415 | |
Contact: Principal Investigator | |
Instituto do Cancer do Estado de Sao Paulo (ICESP) | Not yet recruiting |
São Paulo, Brazil, 01246-000 | |
Contact: Principal Investigator | |
Canada, Alberta | |
Tom Baker Cancer Centre | Not yet recruiting |
Calgary, Alberta, Canada, T2N4N2 | |
Contact: Principal Investigator | |
Canada, Ontario | |
The Ottawa Hospital Cancer Centre | Not yet recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Principal Investigator | |
Canada, Quebec | |
CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont | Not yet recruiting |
Montréal, Quebec, Canada, H1T 2M4 | |
Contact: Principal Investigator | |
CHUM | Not yet recruiting |
Montréal, Quebec, Canada, H2X3E4 | |
Contact: Principal Investigator | |
Jewish General Hospital Segal Cancer Centre | Not yet recruiting |
Montréal, Quebec, Canada, H3T1E2 | |
Contact: Principal Investigator | |
McGill University Health Centre - Cedars Cancer Centre | Not yet recruiting |
Montréal, Quebec, Canada, H4A 3J1 | |
Contact: Principal Investigator | |
CHU de Quebec - Hopital du Saint-Sacrement | Not yet recruiting |
Québec, Quebec, Canada, G1S 4L8 | |
Contact: Principal Investigator | |
Chile | |
Hospital Clinico Universidad de Chile | Not yet recruiting |
Santiago, RM, Chile, 8380456 | |
Contact: Principal Investigator | |
Fundacion Arturo Lopez Perez | Not yet recruiting |
Santiago, Chile, 7500921 | |
Contact: Principal Investigator | |
SIM CRC | Not yet recruiting |
Temuco, Chile, 4780000 | |
Contact: Principal Investigator | |
China | |
Peking University Cancer Hospital | Not yet recruiting |
Beijing, China, 100142 | |
Contact: See Central Contact | |
Peking University Third Hospital | Not yet recruiting |
Beijing, China, 100191 | |
Contact: See Central Contact | |
Jilin University JLU - First Affiliated Hospital | Not yet recruiting |
Changchun, China, 19512 | |
Contact: See Central Contact | |
Sichuan University - West China Hospital | Not yet recruiting |
Chengdu, China, 610041 | |
Contact: See Central Contact | |
Chongqing Medical University - The First Affiliated Hospital | Not yet recruiting |
Chongqing, China, 400016 | |
Contact: See Central Contact | |
Union Hospital of Fujian Medical University | Not yet recruiting |
Fuzhou, China, 35001 | |
Contact: See Central Contact | |
Sun Yat-sen Memorial Hospital | Not yet recruiting |
Guangzhou, China, 510030 | |
Contact: See Central Contact | |
Guangdong Academy of Medical Science | Not yet recruiting |
Guangzhou, China, 510080 | |
Contact: See Central Contact | |
Zhejiang Cancer Hospital | Not yet recruiting |
Hangzhou, China, 310002 | |
Contact: See Central Contact | |
Second Affiliated Hospital of Zhejiang University | Not yet recruiting |
Hangzhou, China, 310009 | |
Contact: See Central Contact | |
Harbin Medical University Cancer Hospital | Not yet recruiting |
Harbin, China, 150060 | |
Contact: See Central Contact | |
Shandong Cancer Hospital | Not yet recruiting |
Jinan, China, 250117 | |
Contact: See Central Contact | |
Nanchang University - The First Affiliated Hospital | Not yet recruiting |
Nanchang, China, 330006 | |
Contact: See Central Contact | |
Nanjing Medical University NMU - Jiangsu Province Hospital | Not yet recruiting |
Nanjing, China, 210029 | |
Contact: See Central Contact | |
Fudan University Cancer Hospital | Not yet recruiting |
Shanghai, China, 200032 | |
Contact: See Central Contact | |
Liaoning Cancer Hospital Institute | Not yet recruiting |
Shenyang, China, 110042 | |
Contact: See Central Contact | |
The 4th Hospital of Heibei Medical University | Not yet recruiting |
Shijiazhuang, China, 50011 | |
Contact: See Central Contact | |
The First Affiliated Hospital of Xiamen University | Not yet recruiting |
Xiamen, China, 361003 | |
Contact: See Central Contact | |
Czechia | |
University Hospital Brno | Not yet recruiting |
Brno, Czechia, 62500 | |
Contact: Principal Investigator | |
Fakultni nemocnice Kralovske Vinohrady | Not yet recruiting |
Prague, Czechia, 10034 | |
Contact: Principal Investigator | |
Denmark | |
Aalborg University Hospital | Not yet recruiting |
Aalborg, Denmark, 9000 | |
Contact: Principal Investigator | |
Aarhus University Hospital | Not yet recruiting |
Aarhus, Denmark, 8210 | |
Contact: Principal Investigator | |
Rigshospitalet | Not yet recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Principal Investigator | |
Odense University Hospital | Not yet recruiting |
Odense, Denmark, 5000 | |
Contact: Principal Investigator | |
Soenderborg sygehus | Not yet recruiting |
Syddanmark, Denmark, 6400 | |
Contact: Principal Investigator | |
France | |
Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux | Not yet recruiting |
Bordeaux, Gironde, France, 33000 | |
Contact: Principal Investigator | |
Institut Claudius Regaud | Not yet recruiting |
Toulouse, Haute Garonne, France, 31059 | |
Contact: Principal Investigator | |
Institut De Cancerologie De La Loire | Not yet recruiting |
Saint-Priest-en-Jarez, Loire, France, 42270 | |
Contact: Principal Investigator | |
CHR Metz-Thionville | Not yet recruiting |
Metz cedex 03, Lorraine, France, 57085 | |
Contact: Principal Investigator | |
Centre Georges François Leclerc | Not yet recruiting |
Dijon, France, 21000 | |
Contact: Principal Investigator | |
CHD Vendee | Not yet recruiting |
La Roche-sur-Yon, France, 85925 cedex 9 | |
Contact: Principal Investigator | |
Centre Hosp Univ de Grenoble CHUG | Not yet recruiting |
La Tronche, France, 38700 | |
Contact: Principal Investigator | |
Centre Oscar Lambret | Not yet recruiting |
Lille, France, 59000 | |
Contact: Principal Investigator | |
Centre Leon Berard | Not yet recruiting |
Lyon, France, 69008 | |
Contact: Principal Investigator | |
Institut Paoli-Calmettes | Not yet recruiting |
Marseille, France, 13009 | |
Contact: Principal Investigator | |
Centre de Cancérologie du Grand Montpellier | Not yet recruiting |
Montpellier, France, 34070 | |
Contact: Principal Investigator | |
The Sel of Centre dOncologie de Gentilly | Not yet recruiting |
Nancy, France, 54000 | |
Contact: Principal Investigator | |
Centre Antoine Lacassagne | Not yet recruiting |
Nice, France, 6189 | |
Contact: Principal Investigator | |
Hospital St Louis | Not yet recruiting |
Paris, France, 75010 | |
Contact: Principal Investigator | |
Hopital Georges Pompidou | Not yet recruiting |
Paris, France, 75015 | |
Contact: Principal Investigator | |
IUC AP-HP. Sorbonne Université, Hôpital Tenon | Not yet recruiting |
Paris, France, 75020 | |
Contact: Principal Investigator | |
CHU de Poitiers | Not yet recruiting |
Poitiers, France, 86021 | |
Contact: Principal Investigator | |
Centre Eugene Marquis | Not yet recruiting |
Rennes, France, 35042 | |
Contact: Principal Investigator | |
Institut de cancerologie de l'ouest | Not yet recruiting |
Saint-Herblain, France, 44360 | |
Contact: Principal Investigator | |
Strasbourg Europe Cancer Institute | Not yet recruiting |
Strasbourg, France, 67033 | |
Contact: Principal Investigator | |
Germany | |
Gemeinschaftspraxis Dres. Halder / Bangerter | Not yet recruiting |
Augsburg, Germany, 86150 | |
Contact: Principal Investigator | |
Cahrité Campus Mitte | Not yet recruiting |
Berlin, Germany, 10117 | |
Contact: Principal Investigator | |
Praxis Dr. med. J. Schilling | Not yet recruiting |
Berlin, Germany, 10317 | |
Contact: Principal Investigator | |
MediOnko-Institut GbR, Praxisklinik Krebsheilkunde | Not yet recruiting |
Berlin, Germany, 10367 | |
Contact: Principal Investigator | |
DRK Kliniken Berlin Köpenick | Not yet recruiting |
Berlin, Germany, 12559 | |
Contact: Principal Investigator | |
Helios Klinikum Berlin-Buch | Not yet recruiting |
Berlin, Germany, 13125 | |
Contact: Principal Investigator | |
Onkologische Schwerpunktpraxis | Not yet recruiting |
Berlin, Germany, 13349 | |
Contact: Principal Investigator | |
Onkologische Schwerpunktpraxis | Not yet recruiting |
Bielefeld, Germany, 13349 | |
Contact: Principal Investigator | |
Studien GbR Braunschweig | Not yet recruiting |
Braunschweig, Germany, 38108 | |
Contact: Principal Investigator | |
Klinikum Bremen Mitte | Not yet recruiting |
Bremen, Germany, 28205 | |
Contact: Principal Investigator | |
Hämato-Onkologische Praxis im Medicum | Not yet recruiting |
Bremen, Germany, 28209 | |
Contact: Principal Investigator | |
Frauenklinik DIAKO Bremen | Not yet recruiting |
Bremen, Germany, 28239 | |
Contact: Principal Investigator | |
Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen | Not yet recruiting |
Böblingen, Germany, 71065 | |
Contact: Principal Investigator | |
Klinikum Chemnitz gGmbH | Not yet recruiting |
Chemnitz, Germany, 09116 | |
Contact: Principal Investigator | |
DONAUISAR Klinikum | Not yet recruiting |
Deggendorf, Germany, 94469 | |
Contact: Principal Investigator | |
Klinikum Dortmund gGmbH | Not yet recruiting |
Dortmund, Germany, 44137 | |
Contact: Principal Investigator | |
St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology | Not yet recruiting |
Dortmund, Germany, 44137 | |
Contact: Principal Investigator | |
Onkologische Schwerpunktpraxis | Not yet recruiting |
Dresden, Germany, 01067 | |
Contact: Principal Investigator | |
University Hospital Dresden | Not yet recruiting |
Dresden, Germany, 01069 | |
Contact: Principal Investigator | |
Onkozentrum Dresden | Not yet recruiting |
Dresden, Germany, 01127 | |
Contact: Principal Investigator | |
Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe | Not yet recruiting |
Düsseldorf, Germany, 40225 | |
Contact: Principal Investigator | |
Frauenklinik der Universität Erlangen | Not yet recruiting |
Erlangen, Germany, 91054 | |
Contact: Principal Investigator | |
Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum | Not yet recruiting |
Essen, Germany, 45136 | |
Contact: Principal Investigator | |
Universitätsklinikum Essen, Frauenklinik | Not yet recruiting |
Essen, Germany, 45147 | |
Contact: Principal Investigator | |
Klinikum Esslingen GmbH | Not yet recruiting |
Esslingen, Germany, 73730 | |
Contact: Principal Investigator | |
AGAPLESION Markus Krankenhaus | Not yet recruiting |
Frankfurt am main, Germany, 60431 | |
Contact: Principal Investigator | |
Frankfurt University Department of Gynecology and Obstetrics | Not yet recruiting |
Frankfurt, Germany, 60323 | |
Contact: Principal investigator | |
Centrum for Haematology and Oncology | Not yet recruiting |
Frankurt am Main, Germany, 60389 | |
Contact: Principal Investigator | |
Universitätsklinik Freiburg, Klinik für Frauenheilkunde | Not yet recruiting |
Freiburg, Germany, 79106 | |
Contact: Principal Investigator | |
Gynäkologisch-Onkologische SP-Praxis | Not yet recruiting |
Furstenwalde, Germany, 30177 | |
Contact: Principal Investigator | |
Evangelische Kliniken Gelsenkirchen | Not yet recruiting |
Gelsenkirchen, Germany, 45879 | |
Contact: Principal Investigator | |
MVZ II der Niels-Stensen-Kliniken | Not yet recruiting |
Georgsmarienhütte, Germany, 49074 | |
Contact: Principal Investigator | |
SRH Waldklinikum Gera, Brustzentrum Ostthüringen | Not yet recruiting |
Gera, Germany, 07548 | |
Contact: Principal Investigator | |
MVZ Onkologische Kooperation Harz | Not yet recruiting |
Goslar, Germany, 38642 | |
Contact: Principal Investigator | |
Krankenhaus St. Elisabeth und St. Barbara Halle/Saale | Not yet recruiting |
Halle/saale, Germany, 06110 | |
Contact: Principal Investigator | |
University Medical Center | Not yet recruiting |
Hamburg, Germany, 20251 | |
Contact: Principal Investigator | |
Mammazentrum HH am Krankenhaus Jerusalem | Not yet recruiting |
Hamburg, Germany, 20357 | |
Contact: Principal Investigator | |
Albertinen Krankenhaus | Not yet recruiting |
Hamburg, Germany, 22457 | |
Contact: Principal Investigator | |
Gynäkologisch-Ontologische Praxis Hannover | Not yet recruiting |
Hannover, Germany, 30177 | |
Contact: Principal Investigator | |
DIAKOVERE Henriettenstift Frauenklinik | Not yet recruiting |
Hannover, Germany, 30559 | |
Contact: Principal Investigator | |
Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz | Not yet recruiting |
Hildesheim, Germany, 31134 | |
Contact: Principal Investigator | |
Department of Gyencology and Obstetrics, Saarland University Hospital | Not yet recruiting |
Homburg, Germany, 66424 | |
Contact: Principal Investigator | |
ViDia Christliche Kliniken Karlsruhe | Not yet recruiting |
Karlsruhe, Germany, 76199 | |
Contact: Principal Investigator | |
Elisabethkrankenhaus Kassel, Brustzentrum | Not yet recruiting |
Kassel, Germany, 34117 | |
Contact: Principal Investigator | |
Klinikum Kassel | Not yet recruiting |
Kassel, Germany, 34125 | |
Contact: Principal Investigator | |
University Hospital Schleswig-Holstein | Not yet recruiting |
Kiel, Germany, 24105 | |
Contact: Principal Investigator | |
Institut für Versorgungsforschung in der Onkologie | Not yet recruiting |
Koblenz, Germany, 56068 | |
Contact: Principal Investigator | |
Unifrauenklinik Köln - Studienzentrum Gynäkologie | Not yet recruiting |
Köln, Germany, 50931 | |
Contact: Principal Investigator | |
St. Elisabeth Hospital | Not yet recruiting |
Köln, Germany, 50935 | |
Contact: Principal Investigator | |
Kliniken der Stadt Köln / Brustzentrum Holweide | Not yet recruiting |
Köln, Germany, 51067 | |
Contact: Principal Investigator | |
St. Elisabeth Krankenhaus | Not yet recruiting |
Leipzig, Germany, 50935 | |
Contact: Principal Investigator | |
St. Vincenz KH Limburg | Not yet recruiting |
Limburg, Germany, 65549 | |
Contact: Principal Investigator | |
UKSH Campus Lübeck | Not yet recruiting |
Luebeck, Germany, 23562 | |
Contact: Principal Investigator | |
Universitäts-Frauenklinik | Not yet recruiting |
Magdeburg, Germany, 69120 | |
Contact: Principal Investigator | |
Department of Obstetrics and Gynecology | Not yet recruiting |
Mainz, Germany, 55131 | |
Contact: Principal Investigator | |
Medzinische Fakultät Mannheim, Universität Heidelberg | Not yet recruiting |
Mannheim, Germany, 68167 | |
Contact: Principal Investigator | |
Klinikum Memmingen | Not yet recruiting |
Memmingen, Germany, 87700 | |
Contact: Principal Investigator | |
Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/Brustzentrum | Not yet recruiting |
Minden, Germany, 32429 | |
Contact: Principal Investigator | |
Rotkreuzklinikum München, Frauenklinik | Not yet recruiting |
Muenchen, Germany, 80637 | |
Contact: Principal Investigator | |
Gynaekologie Arabella | Not yet recruiting |
Munich, Germany, 81925 | |
Contact: Principal Investigator | |
Brustzentrum Niederrhein | Not yet recruiting |
Mönchengladbach, Germany, 41061 | |
Contact: Principal Investigator | |
Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH | Not yet recruiting |
München, Germany, 80639 | |
Contact: Principal Investigator | |
LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe | Not yet recruiting |
München, Germany, 81377 | |
Contact: Principal Investigator | |
Dept. OB/GYN Johanna Etienne Krankenhaus | Not yet recruiting |
Neuss, Germany, 41462 | |
Contact: Principal Investigator | |
Ortenau Klinikum Offenburg-Kehl | Not yet recruiting |
Offenburg, Germany, 77694 | |
Contact: Principal Investigator | |
Klinikum Oldenburg AöR | Not yet recruiting |
Oldenburg, Germany, 26133 | |
Contact: Principal Investigator | |
Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbH | Not yet recruiting |
Paderborn, Germany, 33098 | |
Contact: Principal Investigator | |
Klinikum Ernst von Bergmann | Not yet recruiting |
Potsdam, Germany, 14467 | |
Contact: Principal Investigator | |
Studienzentrum Onkologie Ravensburg | Not yet recruiting |
Ravensburg, Germany, 88212 | |
Contact: Principal Investigator | |
Oncologianova GmbH | Not yet recruiting |
Recklinghausen, Germany, 45659 | |
Contact: Principal Investigator | |
RoMed Klinikum Rosenheim | Not yet recruiting |
Rosenheim, Germany, 83022 | |
Contact: Principal Investigator | |
Univ-Hospital, Dept Ob/Gyn | Not yet recruiting |
Rostock, Germany, 18059 | |
Contact: Principal Investigator | |
CaritasKlinikum St. Theresia | Not yet recruiting |
Saarbrücken, Germany, 66113 | |
Contact: Principal Investigator | |
Onkologische Schwerpunktpraxis Speyer | Not yet recruiting |
Speyer, Germany, 67346 | |
Contact: Principal Investigator | |
G.SUND Gynäkologie Kompetenzzentrum | Not yet recruiting |
Stralsund, Germany, 18435 | |
Contact: Principal Investigator | |
KKH Torgau | Not yet recruiting |
Torgau, Germany, 04860 | |
Contact: Principal Investigator | |
Klinikum Mutterhaus | Not yet recruiting |
Trier, Germany, 54290 | |
Contact: Principal Investigator | |
Praxisnetzwerk Hämatologie/Internistische Onkologie | Not yet recruiting |
Troisdorf, Germany, 53840 | |
Contact: Principal Investigator | |
Frauenklinik | Not yet recruiting |
Tuebingen, Germany, 91054 | |
Contact: Principal Investigator | |
Universitätsfrauenklinik Ulm | Not yet recruiting |
Ulm, Germany, 89081 | |
Contact: Principal Investigator | |
Schwarzwald - Baar Klinikum Frauenklinik | Not yet recruiting |
Villingen-Schwenningen, Germany, 78052 | |
Contact: Principal Investigator | |
Harzklinikum Dorothea Christiane Erxleben | Not yet recruiting |
Wernigerode, Germany, 06484 | |
Contact: Principal Investigator | |
St. Anna Hospital Brustzentrum | Not yet recruiting |
Witten, Germany, 44649 | |
Contact: Principal Investigator | |
Greece | |
General Hospital of Athens Alexandra Clinic | Not yet recruiting |
Athens, Attiki, Greece, 11528 | |
Contact: Principal Investigator | |
University General Hospital of Heraklion | Not yet recruiting |
Heraklion, Crete, Greece, 71110 | |
Contact: Principal Investigator | |
University General Hospital of Patras | Not yet recruiting |
Patras, Western Greece, Greece, 265 04 | |
Contact: Principal Investigator | |
General Hospital of Patras Agios Andreas | Not yet recruiting |
Patras, Greece, 26335 | |
Contact: Principal Investigator | |
Hong Kong | |
Pamela Youde Nethersole Eastern Hospital PYNEH | Not yet recruiting |
Hong Kong, Hong Kong, 10101 | |
Contact: See Central Contact | |
The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) | Not yet recruiting |
Hong Kong, Hong Kong, 999077 | |
Contact: See Central Contact | |
The University of Hong Kong (HKU) - Queen Mary Hospital (QMH) | Not yet recruiting |
Pok Fu Lam, Hong Kong, 10101 | |
Contact: See Central Contact | |
Ireland | |
Saint Vincents University Hospital | Not yet recruiting |
Dublin, Ie-d, Ireland, 4 | |
Contact: Principal Investigator | |
St. James Hospital | Not yet recruiting |
Dublin, Leinster, Ireland, D8 | |
Contact: Principal Investigator | |
University College Cork | Not yet recruiting |
Cork, Ireland, T12 YN60 | |
Contact: Principal Investigator | |
Mater Misericordiae University Hospital | Not yet recruiting |
Dublin, Ireland, 7 | |
Contact: Principal Investigator | |
University Hospital Limerick | Not yet recruiting |
Limerick, Ireland, V94 F858 | |
Contact: Principal Investigator | |
Israel | |
Soroka MC | Not yet recruiting |
Be'er Sheva, Hadarom, Israel, 8410101 | |
Contact: Principal Investigator | |
Sheba Medical Center | Not yet recruiting |
Ramat Gan, Tel Aviv, Israel, 5262100 | |
Contact: Principal Investigator | |
Hadassah Medical Center | Not yet recruiting |
Jerusalem, Israel, 91120 | |
Contact: Principal Investigator | |
Rabin Medical Center | Not yet recruiting |
Petah tikva, Israel, 49100 | |
Contact: Principal Investigator | |
Italy | |
Azienda Ospedaliera Garibaldi-Nesima | Not yet recruiting |
Catania, CT, Italy, 95122 | |
Contact: Principal Investigator | |
Istituto Europeo di Oncologia | Not yet recruiting |
Milan, MI, Italy, 20141 | |
Contact: Principal Investigator | |
Clinica Oncologica, Ospedali Riuniti Umberto 1 | Not yet recruiting |
Ancona, Italy, 60126 | |
Contact: Principal Investigator | |
Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione Oncologica | Not yet recruiting |
Aviano, Italy, 33081 | |
Contact: Principal Investigator | |
Istituto Oncologico di Bari | Not yet recruiting |
Bari, Italy, 70124 | |
Contact: Principal Investigator | |
Azienda ULSS n. 1 Dolomiti | Not yet recruiting |
Belluno, Italy, 32100 | |
Contact: Principal Investigator | |
Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii | Not yet recruiting |
Bologna, Italy, 40138 | |
Contact: Principal Investigator | |
Presidio Ospedaliero di Summa - Antonio Perrino | Not yet recruiting |
Brindisi, Italy, 72100 | |
Contact: Principal Investigator | |
Istitutoperla Ricercaela Curadel Cancro IRCC | Not yet recruiting |
Candiolo, Italy, 10060 | |
Contact: Principal Investigator | |
Istituto Naz per la Ricerca sul Cancro (IST) Genov | Not yet recruiting |
Genova, Italy, 16132 | |
Contact: Principal Investigator | |
Area Vasta Sud Est Sede Operativa Grosseto | Not yet recruiting |
Grosseto, Italy, 58100 | |
Contact: Principal Investigator | |
IRCCS Ospedale San Raffaele | Not yet recruiting |
Milano, Italy, 20132 | |
Contact: Principal Investigator | |
University Hospital of Modena | Not yet recruiting |
Modena, Italy, 41122 | |
Contact: Principal Investigator | |
INT Fondazione Pascale | Not yet recruiting |
Napoli, Italy, 80131 | |
Contact: Principal Investigator | |
Istituto Oncologico Veneto IRCCS | Not yet recruiting |
Padova, Italy, 35128 | |
Contact: Principal Investigator | |
Azienda Ospedaliera di Perugia | Not yet recruiting |
Perugia, Italy, 06132 | |
Contact: Principal Investigator | |
A.O.U. Citta della Salute e della Scienza di Torino | Not yet recruiting |
Torino, Italy, 10126 | |
Contact: Principal Investigator | |
Japan | |
Hyogo Cancer Center | Not yet recruiting |
Akashi City, Japan, 673-8558 | |
Contact: See Central Contact | |
National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH) | Recruiting |
Chuo-Ku, Japan, 104-0045 | |
Contact: See Central Contact | |
National Hospital Organization - National Kyushu Cancer Center | Recruiting |
Fukuoka City, Japan, 811-1395 | |
Contact: See Central Contact | |
Hiroshima City Hiroshima Citizens Hospital | Recruiting |
Hiroshima City, Japan, 730-8518 | |
Contact: See Central Contact | |
Tokai University Hospital - Isehara Campus | Recruiting |
Isehara City, Japan, 253-0036 | |
Contact: See Central Contact | |
Sagara Hospital | Recruiting |
Kagoshima City, Japan, 892-0833 | |
Contact: See Central Contact | |
National Cancer Center Hospital East (NCCHE) - Kashiwa Campus | Recruiting |
Kashiwa City, Japan, 277-8577 | |
Contact: See Central Contact | |
Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center | Recruiting |
Koto-Ku, Japan, 135-8550 | |
Contact: See Central Contact | |
Kyoto University Hospital | Not yet recruiting |
Kyoto, Japan, 606-8507 | |
Contact: See Central Contact | |
National Hospital Organization (NHO) - Shikoku Cancer Center | Recruiting |
Matsuyama City, Japan, 791-0280 | |
Contact: See Central Contact | |
Aichi Cancer Center Hospital | Not yet recruiting |
Nagoya City, Japan, 464-8681 | |
Contact: See Central Contact | |
Niigata Cancer Center Hospital | Recruiting |
Niigata City, Japan, 951-8133 | |
Contact: See Central Contact | |
Hyogo College of Medicine Hospital | Recruiting |
Nishinomiya City, Japan, 663-8501 | |
Contact: See Central Contact | |
Okayama University Hospital | Recruiting |
Okayama City, Japan, 700-8558 | |
Contact: See Central Contact | |
National Hospital Organization - Osaka National Hospital (ONH) | Recruiting |
Osaka City, Japan, 540-0006 | |
Contact: See Central Contact | |
Osaka International Cancer Institute (OICI) | Recruiting |
Osaka City, Japan, 541-8567 | |
Contact: See Central Contact | |
Saitama Cancer Center | Recruiting |
Saitama, Japan, 362-0806 | |
Contact: See Central Contact | |
National Hospital Organization - Hokkaido Cancer Center | Recruiting |
Sapporo City, Japan, 003-0804 | |
Contact: See Central Contact | |
Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center | Not yet recruiting |
Sayama City, Japan, 589-8511 | |
Contact: See Central Contact | |
Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO) | Recruiting |
Sendai City, Japan, 980-8574 | |
Contact: See Central Contact | |
Showa University Hospital - Breast Center | Recruiting |
Shinagawa-Ku, Japan, 1428666 | |
Contact: See Central Contact | |
Tokyo Medical University Hospital | Recruiting |
Shinjuku-Ku, Japan, 160-0023 | |
Contact: See Central Contact | |
Shizuoka Cancer Center (SCC) | Recruiting |
Shizuoka, Japan, 411-8777 | |
Contact: See Central Contact | |
Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute) | Recruiting |
Yokohama City, Japan, 241-8515 | |
Contact: See Central Contact | |
Korea, Republic of | |
Kyungpook National University Hospital | Not yet recruiting |
Daegu, Korea, Republic of, 41944 | |
Contact: See Central Contact | |
National Cancer Center | Not yet recruiting |
Gyeonggi-do, Korea, Republic of, 10408 | |
Contact: See Central Contact | |
CHA Bundang Medical Center CHA University | Not yet recruiting |
Gyeonggi-do, Korea, Republic of, 13496 | |
Contact: See Central Contact | |
Seoul National University Bundang Hospital | Not yet recruiting |
Gyeonggi-do, Korea, Republic of, 13620 | |
Contact: See Central Contact | |
Gachon University Gil Medical Center | Recruiting |
Incheon, Korea, Republic of, 21565 | |
Contact: See Central Contact | |
Samsung Medical Center | Recruiting |
Irwon-dong, Korea, Republic of, 06351 | |
Contact: See Central Contact | |
Korea University Anam Hospital | Recruiting |
Seoul, Korea, Republic of, 02841 | |
Contact: See Central Contact | |
Seoul National University Hospital | Not yet recruiting |
Seoul, Korea, Republic of, 03080 | |
Contact: See Central Contact | |
Severance Hospital | Not yet recruiting |
Seoul, Korea, Republic of, 03722 | |
Contact: See Central Contact | |
Asan Medical Center | Not yet recruiting |
Songpa-gu, Korea, Republic of, 05505 | |
Contact: See Central Contact | |
Soon Chun Hyang Central Medical Center (SCHMC) | Not yet recruiting |
Yongsan, Korea, Republic of, 330-721 | |
Contact: See Central Contact | |
Mexico | |
Clinstile SA de CV | Not yet recruiting |
Ciudad de mexico, Cdmx, Mexico, 06700 | |
Contact: Principal Investigator | |
CIMAB S.A. de C.V | Not yet recruiting |
Torreon, Coahuila, Mexico, 27000 | |
Contact: Principal Investigator | |
Hospital Civil de Guadalajara Fray Antonio Alcalde | Not yet recruiting |
Guadalajara, JAL, Mexico, 44280 | |
Contact: Principal Investigator | |
Consultorio del Dr. Joaqun Gabriel Reinoso Toledo | Not yet recruiting |
Monterrey, Nuevo Leon, Mexico, 64320 | |
Contact: Principal Investigator | |
Netherlands | |
Amsterdam UMC - VU Medisch Centrum | Not yet recruiting |
Amsterdam, Noord-Holland, Netherlands, 1081 HZ | |
Contact: Principal Investigator | |
Amphia Hospital Breda | Not yet recruiting |
Breda, Netherlands, 4800 RK | |
Contact: Principal Investigator | |
Erasmus MC - Daniel den Hoed Oncologisch Centrum | Not yet recruiting |
Rotterdam, Netherlands, 3000 CA | |
Contact: Principal Investigator | |
Peru | |
Hospital Nacional Arzobispo Loayza | Not yet recruiting |
Lima, Peru, 15082 | |
Contact: Principal Investigator | |
Clinica Ricardo Palma | Not yet recruiting |
Lima, Peru, Lima 27 | |
Contact: Principal Investigator | |
Instituto Nacional de Enfermedades Neoplasicas INEN | Not yet recruiting |
Lima, Peru, Lima 34 | |
Contact: Principal Investigator | |
Centro de Investigación Clinica Trujillo EIRL | Not yet recruiting |
Trujillo, Peru, 13001 | |
Contact: Principal Investigator | |
Poland | |
SP Zoz Opolskie Centrum Onkologii IM | Not yet recruiting |
Opole, Opolskie, Poland, 45-061 | |
Contact: Principal Investigator | |
Uniwersyteckie Centrum Kliniczne | Not yet recruiting |
Gdańsk, Pomorskie, Poland, 80-211 | |
Contact: Principal Investigator | |
Centrum Medyczne HCP Sp. z o.o. | Not yet recruiting |
Poznań, Wielkopolskie, Poland, 61-485 | |
Contact: Principal Investigator | |
MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery | Not yet recruiting |
Warsaw, Poland, 02-781 | |
Contact: Principal Investigator | |
Instytut Centrum Zdrowia Matki Polki | Not yet recruiting |
Łódź, Poland, 93-338 | |
Contact: Principal Investigator | |
Portugal | |
Hospital da Senhora da Oliveira, Guimarães EPE | Not yet recruiting |
Guimarães, Portugal, 4835-044 | |
Contact: Principal Investigator | |
Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE | Not yet recruiting |
Lisboa, Portugal, 1099-023 | |
Contact: Principal Investigator | |
Fundação Champalimaud | Not yet recruiting |
Lisboa, Portugal, 1400-038 | |
Contact: Principal Investigator | |
Centro Hospitalar de Lisboa Ocidental, EPE | Not yet recruiting |
Lisboa, Portugal, 1449-005 | |
Contact: Principal Investigator | |
Hospital da Luz | Not yet recruiting |
Lisboa, Portugal, 1500-650 | |
Contact: Principal Investigator | |
Hospital CUF Descobertas | Not yet recruiting |
Lisboa, Portugal, 1998-018 | |
Contact: Principal Investigator | |
Hospital Beatriz Ângelo | Not yet recruiting |
Loures, Portugal, 2674-514 | |
Contact: Principal Investigator | |
Unidade Local de Saúde de Matosinhos, EPE | Not yet recruiting |
Matosinhos, Portugal, 4464-513 | |
Contact: Principal Investigator | |
Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Not yet recruiting |
Porto, Portugal, 4200-072 | |
Contact: Principal Investigator | |
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE | Not yet recruiting |
Vila Nova De Gaia, Portugal, 4434-502 | |
Contact: Principal Investigator | |
Romania | |
Institutul Oncologic Prof. Dr. Ion Chiricuta | Not yet recruiting |
Cluj-Napoca, Cluj, Romania, 400015 | |
Contact: Principal Investigator | |
Onco Clinic Consult SA | Not yet recruiting |
Craiova, Dolj, Romania, 200103 | |
Contact: Principal Investigator | |
Centrul de Oncologie Sfantu Nectarie | Not yet recruiting |
Craiova, Dolj, Romania, 200347 | |
Contact: Principal Investigator | |
Institutul Oncologic Bucuresti IOB | Not yet recruiting |
Bucharest, Romania, 22328 | |
Contact: Principal Investigator | |
Russian Federation | |
State Budget Healthcare Institution of Stavropol Region | Not yet recruiting |
Pyatigorsk, Stavropol Region, Russian Federation, 357502 | |
Contact: Principal Investigator | |
SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary | Not yet recruiting |
Arkhangel'sk, Russian Federation, 163045 | |
Contact: Principal Investigator | |
State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region | Not yet recruiting |
Sochi, Russian Federation, 354057 | |
Contact: Principal Investigator | |
Singapore | |
National University Cancer Institute | Not yet recruiting |
Singapore, Singapore, 119074 | |
Contact: See Central Contact | |
National Cancer Center Singapore | Not yet recruiting |
Singapore, Singapore, 169610 | |
Contact: See Central Contact | |
Spain | |
Hospital Universitario de Basurto | Not yet recruiting |
Bilbao, Bizkaia, Spain, 48013 | |
Contact: Principal Investigator | |
Hospital Clínico Universitario Virgen de la Arrixaca | Not yet recruiting |
El Palmar, Murcia, Spain, 30120 | |
Contact: Principal Investigator | |
Vithas Xanit International Hospital | Not yet recruiting |
Benalmádena, Málaga, Spain, 29630 | |
Contact: Principal Investigator | |
Hospital Universitario Sant Joan Reus | Not yet recruiting |
Reus, Tarragona, Spain, 43204 | |
Contact: Principal Investigator | |
Hospital Universitario Fundación Alcorcón | Not yet recruiting |
Alcorcón, Spain, 28922 | |
Contact: Principal Investigator | |
Hospital General Universitario de Alicante | Not yet recruiting |
Alicante, Spain, 03010 | |
Contact: Principal Investigator | |
Hospital Universitario de Torrevieja | Not yet recruiting |
Alicante, Spain, 03186 | |
Contact: Principal Investigator | |
Hospital de San Juan de Alicante | Not yet recruiting |
Alicante, Spain, 03550 | |
Contact: Principal Investigator | |
Hospital del Mar | Not yet recruiting |
Barcelona, Spain, 08003 | |
Contact: Principal Investigator | |
IOB Institute Of Oncology-Hospital Quironsalud Barcelona | Not yet recruiting |
Barcelona, Spain, 08023 | |
Contact: Principal Investigator | |
Hospital Universitari Vall d'Hebron | Not yet recruiting |
Barcelona, Spain, 08035 | |
Contact: Principal Investigator | |
Hospital Clínic de Barcelona | Not yet recruiting |
Barcelona, Spain, 08036 | |
Contact: Principal Investigator | |
Hospital Universitari Mútua Terrassa | Not yet recruiting |
Barcelona, Spain, 08221 | |
Contact: Principal Investigator | |
Hospital de Mataró | Not yet recruiting |
Barcelona, Spain, 08304 | |
Contact: Principal Investigator | |
ICO Hospitalet | Not yet recruiting |
Barcelona, Spain, 08907 | |
Contact: Principal Investigator | |
ICO Badalona | Not yet recruiting |
Barcelona, Spain, 2050 | |
Contact: Principal Investigator | |
Consorcio Hospitalario Provincial de Castelló | Not yet recruiting |
Castelló, Spain, 12002 | |
Contact: Principal Investigator | |
Complejo Hospitalario Universitario A Coruña (CHUA) | Not yet recruiting |
Coruña, Spain, 15006 | |
Contact: Principal Investigator | |
Hospital Universitario San Pedro de Alcantara | Not yet recruiting |
Cáceres, Spain, 10001 | |
Contact: Principal Investigator | |
ICO Girona | Not yet recruiting |
Girona, Spain, 17007 | |
Contact: Principal Investigator | |
Hospital Universitario Clínico San Cecilio | Not yet recruiting |
Granada, Spain, 18016 | |
Contact: Principal Investigator | |
Complejo Hospitalario de Jaen | Not yet recruiting |
Jaén, Spain, 23007 | |
Contact: Principal Investigator | |
Complejo Asistencial Universitario de León | Not yet recruiting |
León, Spain, 24001 | |
Contact: Principal Investigator | |
Hospital Arnau de Vilanova de Lleida | Not yet recruiting |
Lleida, Spain, 25198 | |
Contact: Principal Investigator | |
Clinica Universidad De Navarra, Madrid | Not yet recruiting |
Madrid, Spain, 28027 | |
Contact: Principal Investigator | |
Hospital MD Anderson Cancer Center Madrid | Not yet recruiting |
Madrid, Spain, 28033 | |
Contact: Principal Investigator | |
Hospital Universitario Ramón y Cajal | Not yet recruiting |
Madrid, Spain, 28034 | |
Contact: Principal Investigator | |
Hospital Universitario Fundación Jiménez Díaz | Not yet recruiting |
Madrid, Spain, 28040 | |
Contact: Principal Investigator | |
Hospital Universitario 12 de Octubre | Not yet recruiting |
Madrid, Spain, 28041 | |
Contact: Principal Investigator | |
Hospital Universitario La Paz | Not yet recruiting |
Madrid, Spain, 28046 | |
Contact: Principal Investigator | |
HM Sanchinarro (CIOCC) | Not yet recruiting |
Madrid, Spain, 28050 | |
Contact: Principal Investigator | |
Hospital Universitario Puerta de Hierro de Majadahonda | Not yet recruiting |
Madrid, Spain, 28222 | |
Contact: Principal Investigator | |
Hospital Universitario HM Puerta del Sur | Not yet recruiting |
Madrid, Spain, 28938 | |
Contact: Principal Investigator | |
Hospital Universitario de Fuenlabrada | Not yet recruiting |
Madrid, Spain, 28942 | |
Contact: Principal Investigator | |
Hospital General Universitario Morales Meseguer | Not yet recruiting |
Murcia, Spain, 30008 | |
Contact: Principal Investigator | |
Hospital Universitario Virgen de la Victoria | Not yet recruiting |
Málaga, Spain, 29010 | |
Contact: Principal Investigator | |
Hospital Universitario Rey Juan Carlos | Not yet recruiting |
Móstoles, Spain, 28933 | |
Contact: Principal Investigator | |
Complejo Hospitalario de Navarra | Not yet recruiting |
Navarro, Spain, 31008 | |
Contact: Principal Investigator | |
Hospital Universitari Son Espases | Not yet recruiting |
Palma De Mallorca, Spain, 07120 | |
Contact: Principal Investigator | |
Hospital Son Llatzer | Not yet recruiting |
Palma De Mallorca, Spain, 07198 | |
Contact: Principal Investigator | |
Hospital Universitario de Canarias | Not yet recruiting |
San Cristobal de la Laguna, Spain, 38320 | |
Contact: Principal Investigator | |
Hospital General de Catalunya | Not yet recruiting |
Sant Cugat Del Vallès, Spain, 08195 | |
Contact: Principal Investigator | |
Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS) | Not yet recruiting |
Santiago De Compostela, Spain, 15706 | |
Contact: Principal Investigator | |
Hospital Universitario Virgen Macarena | Not yet recruiting |
Sevilla, Spain, 41009 | |
Contact: Principal Investigator | |
Hospital Quirón Salud Sagrado Corazón | Not yet recruiting |
Sevilla, Spain, 41013 | |
Contact: Principal Investigator | |
Hospital Universtiario Virgen del Rocio | Not yet recruiting |
Sevilla, Spain, 41013 | |
Contact: Principal Investigator | |
Fundación Instituto Valenciano de Oncologia (IVO) | Not yet recruiting |
Valencia, Spain, 46009 | |
Contact: Principal Investigator | |
Hospital Clínico Universitario de Valencia | Not yet recruiting |
Valencia, Spain, 46010 | |
Contact: Principal Investigator | |
Hospital Arnau de Vilanova de Valencia | Not yet recruiting |
Valencia, Spain, 46015 | |
Contact: Principal Investigator | |
Hospital Clínico Universitario Lozano Blesa | Not yet recruiting |
Zaragoza, Spain, 50009 | |
Contact: Principal Investigator | |
Taiwan | |
E-Da Cancer Hospital | Not yet recruiting |
Kaohsiung, Yanchao District, Taiwan, 82445 | |
Contact: See Central Contact | |
Koo Foundation Sun Yat-Sen Cancer Center | Not yet recruiting |
Beitou, Taiwan, 112 | |
Contact: See Central Contact | |
Changhua Christian Hospital (CCH) | Not yet recruiting |
Chang Hua, Taiwan, 50006 | |
Contact: See Central Contact | |
Kaohsiung Medical University Chung-Ho Memorial Hospital | Not yet recruiting |
Kaohsiung, Taiwan, 80756 | |
Contact: See Central Contact | |
China Medical University Hospital | Not yet recruiting |
Taichung, Taiwan, 40447 | |
Contact: See Central Contact | |
Taichung Veterans General Hospital | Not yet recruiting |
Taichung, Taiwan, 40705 | |
Contact: See Central Contact | |
National Cheng Kung University Hospital | Not yet recruiting |
Tainan, Taiwan, 704 | |
Contact: See Central Contact | |
Chi Mei Medical Center CMMC - Yongkang Branch | Not yet recruiting |
Tainan, Taiwan, 71004 | |
Contact: See Central Contact | |
National Taiwan University Hospital NTUH | Recruiting |
Taipei, Taiwan, 10002 | |
Contact: See Central Contact | |
MacKay Memorial Hospital | Not yet recruiting |
Taipei, Taiwan, 10449 | |
Contact: See Central Contact | |
Taipei Veterans General Hospital TPVGH | Not yet recruiting |
Taipei, Taiwan, 111217 | |
Contact: See Central Contact | |
Tri-Service General Hospital | Not yet recruiting |
Taipei, Taiwan, 114 | |
Contact: See Central Contact | |
Chang Gung Memorial Hospital CGMH | Not yet recruiting |
Taipei, Taiwan, 33305 | |
Contact: See Central Contact | |
Turkey | |
Hacettepe University Cancer Institute | Not yet recruiting |
Ankara, İç Anadolu, Turkey, 6100 | |
Contact: Principal Investigator | |
Trakya University Medical Faculty | Not yet recruiting |
Edirne, Turkey, 22030 | |
Contact: Principal Investigator | |
Istanbul Medeniyet University Medical Faculty | Not yet recruiting |
Istanbul, Turkey, 34093 | |
Contact: Principal Investigator | |
Medical Park - Izmir Hastanesi | Not yet recruiting |
İzmir, Turkey, 35575 | |
Contact: Principal Investigator | |
United Kingdom | |
Peterborough City Hospital | Not yet recruiting |
Peterborough, Cambridgeshire, United Kingdom, PE3 9NZ | |
Contact: Principal Investigator | |
Kent Oncology Centre Maidstone Hospital | Not yet recruiting |
Maidstone, Kent, United Kingdom, ME16 9QQ | |
Contact: Principal Investigator | |
The Christie Hospital | Not yet recruiting |
Manchester, Lancashire, United Kingdom, M20 4XB | |
Contact: Principal Investigator | |
Clatterbridge Cancer Centre | Not yet recruiting |
Wirral, Merseyside, United Kingdom, CH63 4JY | |
Contact: Principal Investigator | |
Nottingham University Hospitals | Not yet recruiting |
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB | |
Contact: Principal Investigator | |
Royal United Hospital Bath NHS Trust - Royal United Hospital RUH | Not yet recruiting |
Bath, Somerset, United Kingdom, BA1 3NG | |
Contact: Principal Investigator | |
Somerset NHS Foundation Trust | Not yet recruiting |
Taunton, Somerset, United Kingdom, TA1 5DA | |
Contact: Principal Investigator | |
St. James University Hospital | Not yet recruiting |
Leeds, West Yorkshire, United Kingdom, LS9 7TF | |
Contact: Principal Investigator | |
Colchester Hospital, East Suffolk & North Essex NHS Foundation Trust | Not yet recruiting |
Colchester, United Kingdom, CO4 5JL | |
Contact: Principal Investigator | |
Royal Devon Exeter NHS Foundation Trust | Not yet recruiting |
Exeter, United Kingdom, EX2 5DW | |
Contact: Principal Investigator | |
Beatson West of Scotland Cancer Centre | Not yet recruiting |
Glasgow, United Kingdom, G12 0YN | |
Contact: Principal Investigator | |
Guys and St Thomas NHS Foundation Trust | Not yet recruiting |
London, United Kingdom, SE1 9RT | |
Contact: Principal Investigator | |
Charing Cross Hospital | Not yet recruiting |
London, United Kingdom, W6 8RF | |
Contact: Principal Investigator | |
Oxford University Hospitals NHS Foundation Trust | Not yet recruiting |
Oxford, United Kingdom, OX3 7LJ | |
Contact: Principal Investigator | |
Blackpool Victoria Hospital | Not yet recruiting |
Peterborough, United Kingdom, FY3 8NR | |
Contact: Principal Investigator |
Study Director: | Global Clinical Leader | Daiichi Sankyo, Inc. |
Responsible Party: | Daiichi Sankyo, Inc. |
ClinicalTrials.gov Identifier: | NCT04622319 |
Other Study ID Numbers: |
DS8201-A-U305 2020-003982-20 ( EudraCT Number ) DESTINY-Breast05 ( Other Identifier: Daiichi Sankyo and AstraZeneca ) NSABP B-60 ( Other Identifier: National Surgical Adjuvant Breast and Bowel Project (NSABP) ) GBG-103 ( Other Identifier: German Breast Group (GBG) ) SOLTI-2001 ( Other Identifier: Spanish Breast Cancer Research Group (SOLTI) ) |
First Posted: | November 9, 2020 Key Record Dates |
Last Update Posted: | April 9, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication. |
Access Criteria: | Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent. |
URL: | https://vivli.org/ourmember/daiichi-sankyo/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
HER2-Positive Primary Breast Cancer Residual Invasive Breast Cancer Trastuzumab Deruxtecan Trastuzumab Emtansine |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Trastuzumab Ado-trastuzumab emtansine |
Antineoplastic Agents, Immunological Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |