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Trial record 1 of 1 for:    bo28407
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A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer

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. Read our disclaimer for details. Identifier: NCT01966471
Recruitment Status : Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : June 30, 2020
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Trastuzumab Emtansine Drug: Trastuzumab Drug: Pertuzumab Drug: Paclitaxel Drug: Epirubicin Drug: Doxorubicin Drug: Docetaxel Drug: Cyclophosphamide Drug: 5-Fluorouracil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1846 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Actual Study Start Date : January 31, 2014
Actual Primary Completion Date : November 27, 2019
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane
Trastuzumab and pertuzumab will be administered concurrently for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) with the taxane (docetaxel or paclitaxel) component of chemotherapy following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
Drug: Trastuzumab
Trastuzumab IV infusion (duration 90 minutes) will be administered at 8 mg/kg loading dose followed by 6 mg/kg IV q3w for up to 18 cycles (1 cycle = 21 days).
Other Name: Herceptin

Drug: Pertuzumab
Pertuzumab infusion (duration 60 minutes) will be administered at 840 mg loading dose followed by 420 mg IV q3w for up to 18 cycles (1 cycle = 21 days).
Other Name: Perjeta

Drug: Paclitaxel
IV infusion of paclitaxel 80 mg/m^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.

Drug: Epirubicin
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Drug: Doxorubicin
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Drug: Docetaxel
IV infusion either docetaxel every 3 weeks (q3w) (at 100 milligram per square meter [mg/m^2] for 3 cycles (1 cycle = 21 days); at 75 mg/m2 for 4 cycles; or start at 75 mg/m^2 in the first cycle and escalate to 100 mg/m^2 if no dose limiting toxicity occurs, for a total of 3 cycles at minimum) may be administered concurrently with trastuzumab in combination with pertuzumab.

Drug: Cyclophosphamide
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Drug: 5-Fluorouracil
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Experimental: Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab
Trastuzumab emtansine and pertuzumab will continue for up to a total duration of 1 year (up to 18 cycles [1 Cycle = 21 days]) following anthracycline [5 fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin and cyclophosphamide (EC) or doxorubicin and cyclophosphamide (AC)] based chemotherapy.
Drug: Trastuzumab Emtansine
Trastuzumab emtansine IV infusion (duration 90 minutes) will be administered at 3.6 mg/kg q3w for up to 18 cycles (1 cycle = 21 days).
Other Name: Kadcyla

Drug: Epirubicin
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Drug: Doxorubicin
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Drug: Cyclophosphamide
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Drug: 5-Fluorouracil
3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.

Primary Outcome Measures :
  1. Invasive Disease-Free Survival (IDFS) in the Overall Population [ Time Frame: Baseline up to approximately 10 years ]
    IDFS is defined as time from randomization to occurrence of ipsilateral breast cancer recurrence, second primary invasive breast cancer, distant recurrence, or death due to any cause.

  2. IDFS in the Node-Positive Subpopulation [ Time Frame: Baseline up to approximately 10 years ]
    IDFS is defined as time from randomization to occurrence of ipsilateral breast cancer recurrence, second primary invasive breast cancer, distant recurrence, or death due to any cause.

Secondary Outcome Measures :
  1. IDFS Plus Second Primary Non-Breast Cancer [ Time Frame: Baseline up to approximately 10 years ]
    IDFS is defined as time from randomization to occurrence of ipsilateral breast cancer recurrence, second primary invasive breast cancer, distant recurrence, or death due to any cause plus second primary non-breast cancer, excluding non-melanoma skin cancers and carcinoma in situ of any site.

  2. Disease-Free Survival (DFS) [ Time Frame: Baseline up to approximately 10 years ]
    DFS is defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS).

  3. Distant Recurrence-Free Interval (DRFI) [ Time Frame: Baseline up to approximately 10 years ]
    DRFI is defined as time between randomization and first occurrence of distant breast cancer recurrence.

  4. Overall Survival (OS) [ Time Frame: Baseline up to approximately 10 years ]
    OS is defined as the time from randomization to death due to any cause.

  5. Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 10 years ]
  6. Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time [ Time Frame: Baseline up to approximately 10 years ]
  7. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score [ Time Frame: From randomization to 24 months after end of treatment visit (up to approximately 3 years) ]
  8. EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score [ Time Frame: From randomization to 24 months after end of treatment visit (up to approximately 3 years) ]
  9. Time to Clinically Meaningful Deterioration in the Global Health Status/ Quality of Life and Functional (Physical, Role, and Cognitive) Subscales of the QLQ-C30 From First HER2-Targeted Treatment [ Time Frame: From randomization to 24 months after end of treatment visit (up to approximately 3 years) ]

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
  • Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable
  • HER2-positive breast cancer
  • Known hormone receptor status of the primary tumor
  • Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
  • Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either:

Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory

  • Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive
  • No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization
  • Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans
  • Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required
  • Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment

Exclusion Criteria:

  • History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma
  • History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer
  • For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)
  • Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy
  • History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study
  • Participants with contraindication to RT while adjuvant RT is clinically indicated
  • Concurrent anti-cancer treatment in another investigational trial
  • Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy
  • Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV
  • Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines
  • Inadequate hematologic, renal or liver function
  • Pregnant or lactating women
  • Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol
  • Chronic immunosuppressive therapies, including systemic corticosteroids

Information from the National Library of Medicine

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 identifier (NCT number): NCT01966471

Hide Hide 296 study locations
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United States, Arizona
HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, United States, 85258
United States, California
Kaiser Permanente - Oakland
Oakland, California, United States, 94611
Kaiser Permanente - Roseville; Oncology Pharmacy
Roseville, California, United States, 95661
Kaiser Permanente - Sacramento; Oncology Pharmacy
Sacramento, California, United States, 95814
UC Davis Cancer Center; Oncology
Sacramento, California, United States, 95817
Southern California Kaiser Permanente
San Diego, California, United States, 92108
Kaiser Permanente - San Jose
San Jose, California, United States, 95119
Kaiser Permanente - San Leandro
San Leandro, California, United States, 94577
Kaiser Permanente - South SF; Oncology Clinical trials
South San Francisco, California, United States, 94080
Stanford University School of Medicine
Stanford, California, United States, 94305-5151
Kaiser Permanente - Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente - Walnut Creek; Oncology Pharmacy
Walnut Creek, California, United States, 94596
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States, 33901
Florida Cancer Specialists; Saint Petersburg
Saint Petersburg, Florida, United States, 33719
United States, Georgia
University Cancer & Blood Center, LLC; Research
Athens, Georgia, United States, 30607
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
Central Georgia Cancer Care PC
Macon, Georgia, United States, 31201
United States, Illinois
Quincy Medical Group; Canc Ctr at Blessing Hosp
Quincy, Illinois, United States, 62301
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214-3728
United States, Maryland
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis, Maryland, United States, 21401
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Dana Farber Cancer Inst.
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute..
Detroit, Michigan, United States, 48201
Henry Ford Hospital; Hematology Oncology
Detroit, Michigan, United States, 48202
United States, Minnesota
US Oncology Research at Minnesota Oncology
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Mercy Medical Research Institute
Springfield, Missouri, United States, 65807
United States, New Hampshire
Dartmouth Hitchcock Med Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Memorial Sloan-Kettering Cancer Center
Commack, New York, United States, 11725
ProHEALTH Care Associates LLP
Lake Success, New York, United States, 11042
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
United States, Ohio
Oncology Hematology Care Inc
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Mercy Clinic Oklahoma Communties, Inc
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, United States, 37404
West Clinic
Germantown, Tennessee, United States, 38138
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916-2305
Sarah Cannon Cancer Center - Tennessee Oncology, Pllc
Nashville, Tennessee, United States, 37203
United States, Texas
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, United States, 76104
United States, Virginia
Wellmont Medical Associates
Bristol, Virginia, United States, 24201
University of Virginia Health System; Hematology/Oncology Division
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, United States, 23298
Blue Ridge Cancer Care - Salem
Salem, Virginia, United States, 24153
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Haematology & Oncology Clinics of Australia Research Centre
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Burnside War Memorial Hospital, Clinical Trials Centre
Adelaide, South Australia, Australia, 5056
Australia, Victoria
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, Australia, 3199
Austin Hospital; Medical Oncology
Heidelberg, Victoria, Australia, 3084
Epworth HealthCare; Clinical Trials Centre
Richmond, Victoria, Australia, 3121
Australia, Western Australia
St John of God Murdoch Hospital; Oncology West
Murdoch, Western Australia, Australia, 6150
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Sint Augustinus Wilrijk, Apotheek
Wilrijk, Belgium, 2610
Bosnia and Herzegovina
University Clinical Center of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 78000
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, Bosnia and Herzegovina, 7100
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania, GO, Brazil, 74605-070
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS, Brazil, 91350-200
Hospital de Cancer de Barretos
Barretos, SP, Brazil, 14784-400
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Hospital Sirio Libanes; Centro de Oncologia
Sao Paulo, SP, Brazil, 01308-050
Hospital Perola Byington
Sao Paulo, SP, Brazil, 01317-000
Hospital Paulistano
Sao Paulo, SP, Brazil, 01321-000
Canada, Alberta
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Bcca - Cancer Center Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Lion'S Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
Regional health authority A vitalite health network
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V6
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, Canada, L5M 2N1
Southlake Regional Health Center; Community Care Clinic / Oncology
Newmarket, Ontario, Canada, L3Y 2P9
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, Canada, L1G 2B9
Sault Area Hospitals
Sault Ste Marie, Ontario, Canada, P6A 2C4
North York General Hospital
Toronto, Ontario, Canada, M2J 1V1
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, Canada, H7M 3L9
McGill University; Glen Site; Oncology
Montreal, Quebec, Canada, H4A 3J1
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY
Quebec, Canada, G1S 4L8
Instituto Oncologico del sur
Temuco, Chile, 4810469
Vina Del Mar, Chile, 2520598
Oncomedica S.A.
Monteria, Colombia, 230002
Masarykuv onkologicky ustav
Brno, Czechia, 656 53
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Kralove, Czechia, 500 05
MULTISCAN, s.r.o., Radiologicke centrum Pardubice
Pardubice, Czechia, 532 03
Vseobecna fakultni nemocnice v Praze
Praha 2, Czechia, 128 08
El Salvador
Hospital Diagnostico Escalón
San Salvador, El Salvador, 01101
Ico - Paul Papin
Angers, France, 49000
Clinique Sainte Catherine
Avignon, France, 84082
Besancon, France, 25030
Institut Bergonie; Oncologie
Bordeaux, France, 33076
CHU de Brest - Hôpital de Morvan
Brest, France, 29609
Centre Francois Baclesse; Oncologie
Caen, France, 14076
Centre Jean Perrin; Oncologie
Clermont Ferrand, France, 63011
Centre Georges Francois Leclerc; Oncologie 3
Dijon, France, 21079
Clinique Victor Hugo; Chimiotherapie
Le Mans, France, 72015
Centre Oscar Lambret; Cancerologie Gynecologique
Lille, France, 59020
Centre Leon Berard; Departement Oncologie Medicale
Lyon, France, 69373
Centre D'Oncologie de Gentilly; Oncology
Nancy, France, 54100
Centre Antoine Lacassagne
Nice, France, 06189
Institut de cancerologie du Gard
Nimes, France, 30029
HOPITAL TENON; Cancerologie Medicale
Paris, France, 75970
Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)
Plerin, France, 22190
Polyclinique De Courlancy; Centre Radiotherapie Oncologie
Reims, France, 51057
Centre Eugene Marquis; Service d'oncologie
Rennes, France, 35042
Ico Rene Gauducheau; Oncologie
Saint Herblain, France, 44805
Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
St Priest En Jarez, France, 42271
Institut d'oncologie de l'Orangerie; Chimiotherapie
Strasbourg, France, 67010
Centre Paul Strauss; Oncologie Medicale
Strasbourg, France, 67065
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, France, 31059
Centre Alexis Vautrin; Oncologie Medicale
Vandoeuvre-les-nancy, France, 54519
LTD Institute of Clinical Oncology
Tbilisi, Georgia, 0159
Khechinashvili University Hospital ;Breast Unit
Tbilisi, Georgia, 0177
Chemotherapy and Immunotherapy Clinic Medulla
Tbilisi, Georgia, 0186
Klinikum Augsburg
Augsburg, Germany, 86156
Bad Nauheim, Germany, 61231
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
Berlin, Germany, 14169
Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
Bochum, Germany, 44787
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, Germany, 01307
AGAPLESION Markus-Krankenhaus
Frankfurt, Germany, 60431
Städtische Kliniken Frankfurt am Main Höchst
Frankfurt, Germany, 65929
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg, Germany, 79110
Dres.Jochen Wilke und Harald Wagner
Fürth, Germany, 90766
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
Georgsmarienhütte, Germany, 49124
Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
Hamburg, Germany, 20246
Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding
Hannover, Germany, 30177
Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
Hannover, Germany, 30625
Klinikum Kulmbach; Frauenklinik
Kulmbach, Germany, 95326
Praxis Katja Ziegler-Löhr
Köln, Germany, 50679
Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, Germany, 23538
Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe
Meiningen, Germany, 98617
Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde
Muenchen, Germany, 81377
Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum
Ravensburg, Germany, 88212
Agaplesion Diakonieklinikum Rotenburg
Rotenburg/Wümme, Germany, 27356
gSUND Gynäkologie Kompetenzzentrum Stralsund; Frauenheilkunde & Geburtshilfe
Stralsund, Germany, 18435
Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis
Troisdorf, Germany, 53840
GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe
Weinheim, Germany, 69469
Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe
Worms, Germany, 67550
Grupo Angeles
Guatemala City, Guatemala, 01015
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala, Guatemala, 01010
Hong Kong
Princess Margaret Hospital; Oncology
Hong Kong, Hong Kong
Tuen Mun Hospital; Clinical Oncology
Hong Kong, Hong Kong
Queen Mary Hospital; Dept of Surgery
Pokfulam, Hong Kong
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, Hungary, 1122
Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology
Budapest, Hungary, 1145
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
Debrecen, Hungary, 4032
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, Hungary, 6720
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 52620-00
Sourasky / Ichilov Hospital; Oncology Department
Tel Aviv, Israel, 64239-06
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy, 80131
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40138
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli-Venezia Giulia, Italy, 33081
Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
Roma, Lazio, Italy, 00128
Istituto Nazionale Tumori Regina Elena IRCCS
Roma, Lazio, Italy, 00144
ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit
Cremona, Lombardia, Italy, 26100
Ospedale San Raffaele
Milano, Lombardia, Italy, 20132
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano, Lombardia, Italy, 20133
ASST DI MONZA; Oncologia Medica
Monza, Lombardia, Italy, 20900
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardia, Italy, 20089
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Puglia, Italy, 72100
Humanitas Centro Catanese Di Oncologia; Oncologia Medica
Misterbianco (CT), Sicilia, Italy, 95045
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Toscana, Italy, 59100
Azienda Ospedaliera S. Maria - Terni; Oncologia
Terni, Umbria, Italy, 05100
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova, Veneto, Italy, 35128
Aichi Cancer Center Hospital, Breast Oncology
Aichi, Japan, 464-8681
Nagoya City University Hospital; Breast Surgery
Aichi, Japan, 467-8602
Natl Hosp Org Shikoku; Cancer Ctr, Surgery
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Cancer Center;Breast Oncology
Fukuoka, Japan, 811-1395
Gunma University Hospital; Department of Breast and Endocrine Surgery
Gunma, Japan, 371-8511
Gunma Prefectural Cancer Center; Breast Oncology
Gunma, Japan, 373-8550
Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
Hiroshima, Japan, 730-8518
Hiroshima University Hospital; Breast Surgery
Hiroshima, Japan, 734-8551
Hyogo College Of Medicine; Breast And Endocrine Surgery
Hyogo, Japan, 663-8501
Iwate Med Univ School of Med; Surgery
Iwate, Japan, 028-3695
Sagara Hospital; Breast Surgery
Kagoshima, Japan, 892-0833
St. Marianna University School of Medicine Hospital, Breast and Endocrine Surgery
Kanagawa, Japan, 216-8511
Tokai University Hospital, Breast and Endocrine Surgery
Kanagawa, Japan, 259-1193
Kumamoto City Hospital, Breast and Endocrine Surgery
Kumamoto, Japan, 862-8505
Kumamoto Shinto General Hospital; Breast Cancer Center
Kumamoto, Japan, 862-8655
Kyoto University Hospital; Breast Surgery
Kyoto, Japan, 606-8507
Niigata Cancer Ctr Hospital; Breast Surgery
Niigata, Japan, 951-8566
Kawasaki Medical School Hospital; Breast and Thyroid Surgery
Okayama, Japan, 701-0114
Naha-nishi Clinic; Surgery
Okinawa, Japan, 901-0154
National Hospital Organization Osaka National Hospital; Breast Surgery
Osaka, Japan, 540-0006
Osaka International Cancer Institute; Breast and Endocrine Surgery
Osaka, Japan, 541-8567
Saitama Medical University International Medical Center; Breast Oncology
Saitama, Japan, 350-1298
Saitama Cancer Center, Breast Oncology
Saitama, Japan, 362-0806
Shizuoka Cancer Center; Female Internal Medicine
Shizuoka, Japan, 411-8777
Shizuoka General Hospital; Breast Surgery
Shizuoka, Japan, 420-8527
Jichi Medical University; Breast Oncology
Tochigi, Japan, 329-0498
National Cancer Center Hospital; Breast and Medical Oncology
Tokyo, Japan, 104-0045
St. Luke's Internat. Hospital, Breast Surgical Oncology
Tokyo, Japan, 104-8560
Tokyo Metropolitan; Komagome Hospital, Surgery
Tokyo, Japan, 113-8677
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
Tokyo, Japan, 135-8550
Showa University Hospital; Breast Surgery
Tokyo, Japan, 142-8666
Tokyo Medical Uni. Hospital; Breast Oncology
Tokyo, Japan, 160-0023
Korea, Republic of
National Cancer Center; Medical Oncology
Gyeonggi-do, Korea, Republic of, 410-769
Ajou Uni Hospital; Medical Oncology
Gyeonggi-do, Korea, Republic of, 443-380
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, Korea, Republic of, 135-710
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
Distrito Federal, Mexico, 14000
Fundacion Rodolfo Padilla Padilla A.C.
León, Mexico, 37000
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
Mexico City, Mexico, 03100
Hospital San Jose Del Tec. de Monterrey; Oncology
Monterrey, Mexico, 64020
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
Oslo, Norway, 0450
Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
Stavanger, Norway, 4011
Centro Hemato Oncologico Panama
Panama, Panama, 0832
Clinica de Especialidades Medicas
Lima, Peru, Lima 41
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Peru, Lima 41
Clinica San Borja
Lima, Peru, Lima 41
Instituto Oncologico Miraflore
Miraflores, Peru, Lima 18
San Juan de Dios Hospital;Oncology Unit
Pasay, Philippines, 1300
East Avenue Medical Center
Quezon City, Philippines, 1100
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok, Poland, 15-027
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, Poland, 85-796
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, Poland, 80-214
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Kraków, Poland, 30-688
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Poradnia Chemioterapii
Lodz, Poland, 93-513
Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
Lublin, Poland, 20-090
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, Poland, 05-400
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warszawa, Poland, 02-781
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti
Bucuresti, Romania, 022328
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca, Romania, 400015
Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, Romania, 400006
Regional Institute of Oncology Iasi
Iasi, Romania, 700483
Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo, Russian Federation, 153040
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
Kazan, Russian Federation, 420029
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow, Russian Federation, 115478
State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
Orenburg, Russian Federation, 460021
SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF
Ryazan, Russian Federation, 390011
Scientific Research Institute n.a. N.N. Petrov
Saint Petersburg, Russian Federation, 197758
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, Singapore, 119228
National Cancer Centre; Medical Oncology
Singapore, Singapore, 169610
Hospital Universitario de Canarias;servicio de Oncologia
La Laguna, Tenerife, Spain, 38320
Hospital de Cruces; Servicio de Oncologia
Bilbao, Vizcaya, Spain, 48903
Hospital del Mar; Servicio de Oncologia
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, Spain, 08035
Hospital Duran i Reynals; Oncologia
Barcelona, Spain, 08907
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, Spain, 28007
Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
Madrid, Spain, 28033
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Malaga, Spain, 29010
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, Spain, 30120
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia, Spain, 46010
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Göteborg, Sweden, 413 45
Akademiska sjukhuset, Onkologkliniken
Uppsala, Sweden, 751 85
Universitetssjukhuset Örebro, Onkologiska kliniken
Örebro, Sweden, 701 85
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, Switzerland, 7000
Luzerner Kantonsspital; Medizinische Onkologie
Luzern, Switzerland, 6004
Zürich, Switzerland, 8008
Changhua Christian Hospital; Dept of Surgery
Changhua, Taiwan, 500
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung, Taiwan, 807
Taichung Veterans General Hospital; Dept of Surgery
Taichung, Taiwan, 407
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, Taiwan, 00112
National Taiwan Uni Hospital; General Surgery
Taipei, Taiwan, 100
Tri-Service General Hospital, Division of General Surgery
Taipei, Taiwan, 114
Chulalongkorn Hospital; Medical Oncology
Bangkok, Thailand, 10330
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, Thailand, 10700
Chiang Rai Prachanukroh Hospital; Department Of Medicine
Chiang Rai, Thailand, 57000
Buddhachinaraj Phitsanulok Hospital; Hemato-oncology Unit; Department of Medicine
Phitsanulok, Thailand, 65000
State Medical Academy; Oncology
Dnipropetrovsk, Ukraine, 43102
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, Ukraine, 79031
United Kingdom
Velindre Cancer Centre; Oncology Dept
Cardiff, United Kingdom, CF14 2TL
Cheltenham General Hospital; Gloucestershire Oncology Centre
Cheltenham, United Kingdom, GL53 7AN
University Hospital Coventry; InHANSE Unit and Clinical Trials Cancer Treatment Centre
Coventry, United Kingdom, CV2 2DX
Western General Hospital; Edinburgh Breast Unit
Edinburgh, United Kingdom, EH4 2XU
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, United Kingdom, EX2 5DW
Royal Surrey County Hospital; St. Lukes Cancer Centre
Guildford, United Kingdom, GU2 7XX
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, United Kingdom, LE1 5WW
Royal Marsden Hospital - Fulham; Oncology Department
London, United Kingdom, SW3 6JJ
Charing Cross Hospital
London, United Kingdom, W6 8RF
Maidstone Hospital; Kent Oncology Centre
Maidstone, United Kingdom, ME16 9QQ
Christie Hospital; Breast Cancer Research Office
Manchester, United Kingdom, M20 4QL
Freeman Hospital; Northern Centre For Cancer Care
New Castle Upon Tyne, United Kingdom, NE7 7DN
Mount Vernon Cancer Centre
Northwood, United Kingdom, HA6 2RN
Nottingham City Hospital; Oncology
Nottingham, United Kingdom, NG5 1PB
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
Peterborough, United Kingdom, PE3 9GZ
Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B
Portsmouth, United Kingdom, PO6 3LY
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, United Kingdom, S10 2SJ
Musgrove Park Hospital; Department Clinical Research, Beacon Centre
Somerset, United Kingdom, TA1 5DA
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
Stoke-on-Trent, United Kingdom, ST4 6QG
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, United Kingdom, SM2 5PT
Royal Cornwall Hospital; Dept of Clinical Oncology
Truro, United Kingdom, TR1 3LJ
Yeovil District Hospital; Macmillan Cancer Unit
Yeovil, United Kingdom, BA21 4AT
YORK DISTRICT HOSPITAL; Haematology/Oncology Department
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Hoffmann-La Roche
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Layout table for additonal information
Responsible Party: Hoffmann-La Roche Identifier: NCT01966471    
Other Study ID Numbers: BO28407
2012-004902-82 ( EudraCT Number )
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Ado-trastuzumab emtansine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors