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Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer (APTneo)

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: NCT03595592
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Fondazione Michelangelo

Brief Summary:
n the present study the neoadjuvant approach with the anti-HER2 trastuzumab and pertuzumab combined with carboplatin and paclitaxel will be used to compare the Event-Free Survival (EFS) in regimens with and without atezolizumab. Following the neoadjuvant part of the study, after surgery all patients will continue to receive trastuzumab and pertuzumab to complete one year of anti-HER2 therapy. Similarly, patients allocated to receive atezolizumab will continue atezolizumab to complete one year In addition, several IHC and molecular assays will be performed before and during the period of chemotherapy administration and at surgery with the goal of defining a marker of efficacy to be later validated in a larger adjuvant setting.

Condition or disease Intervention/treatment Phase
Invasive Breast Cancer Drug: Trastuzumab Drug: Pertuzumab Drug: Carboplatin Drug: Paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide Drug: Atezolizumab Procedure: Surgery Phase 3

Detailed Description:

Dual targeting of HER2 with trastuzumab and pertuzumab in HER2-positive breast cancer is linked to clinical evidence of reversal of initial resistance to trastuzumab (Baselga J et al, J Clin Oncol 2010) in cases progressing on trastuzumab therapy, and in dramatic improvement in progression free and overall survival when the two monoclonal antibodies are used in combination with docetaxel (THP regimen) as first line therapy of metastatic disease as shown in the CLEOPATRA study (Swain S et al, ESMO abstract 2014). The randomized NeoSphere study showed that the same THP regimen given for 4 cycles as neoadjuvant treatment increased the rate of pathologic complete response (pCR) over that with conventional docetaxel and trastuzumab or docetaxel and pertuzumab (Gianni L et al, Lancet Oncol 2012).

Encouraging clinical data emerging in the field of tumor immunotherapy have demonstrated that therapies focused on enhancing T cell responses against cancer can result in a significant survival benefit in patients with advanced malignancies (Hodi FS and Dranoff G, J Cutan Pathol 2010; Kantoff PW et al, New Engl J Med 2010; Chen DS et al, Clin Cancer Res 2012). Many human tumors have been found to overexpress PD L1, which acts to suppress anti tumor immunity. PD 1 is an inhibitory receptor expressed on T cells following T cell activation, which is sustained in states of chronic stimulation, such as in chronic infection or canc Atezolizumab is a human monoclonal antibody containing an engineered Fc-domain to optimize efficacy and safety that targets PD-L1 and blocks binding of its receptors, including PD-1 and B7.1.

In addition to being involved in the natural progression of cancer, immunity can affect the activity of various anticancer agents. Accordingly, recent evidence suggests that some chemotherapeutic drugs, such as anthracyclines and oxaliplatin, rely on the induction of anticancer immune responses. Immune responses also play a major role in the efficacy of targeted therapies with monoclonal antibodies (Stagg J et al, Breast Care 2012). Studies have shown monoclonal antibodies such as trastuzumab and rituximab rely in part on immunemediated killing through antibody-dependent cellular cytotoxicity (ADCC). While innate immune responses appear to be important for tumor antigen-targeted monoclonal antibody therapies, recent studies in mice and correlative clinical evidence suggest that trastuzumab may also stimulate adaptive antitumor immunity. These studies raise the possibility that combination strategies may be used to capitalize on the adaptive tumor-specific immunity generated by anti-HER2 monoclonal antibodies.

Based on these considerations, we plan to conduct a randomized neoadjuvant study of the combination of trastuzumab, pertuzumab, carboplatin and paclitaxel with or without atezolizumab in women with early high-risk and locally advanced HER2-positive suitable for neoadjuvant therapy. One study arm will also include anthracycline and cyclophosphamide.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel randomization to the study arms
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Atezolizumab, Pertuzumab and Trastuzumab With Chemotherapy as Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer (APTneo)
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : December 15, 2026
Estimated Study Completion Date : June 15, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: HPCT
Patients will receive a combination of trastuzumab, pertuzumab, carboplatin and paclitaxel as neoadjuvant therapy for 6 cycles every 3 weeks. Trastuzumab (H) will be delivered on day 1 at the dose of 8 mg/kg loading dose i.v., then 6 mg/kg i.v. Pertuzumab (P) will be delivered on day 1 at the dose of 840 mg loading dose i.v., then 420 mg i.v. Carboplatin (C) will be administered at AUC 2 i.v. on day 1 and day 8. Paclitaxel (T) will be given at 90 mg/m2 i.v. on day 1 and day 8. Definite surgery will be performed not later than 4 weeks after the last dose of neoadjuvant therapy. Trastuzumab and pertuzumab will then be delivered for 12 additional cycles as adjuvant therapy.
Drug: Trastuzumab
Trastuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Herceptin

Drug: Pertuzumab
Pertuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Perjeta

Drug: Carboplatin
Carboplatin will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Carboplatin Hospiria

Drug: Paclitaxel
Paclitaxel will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Paclitaxel Hospiria

Procedure: Surgery
Breast cancer surgery (breast and axilla) either conservative or radical not later than 4 weeks from the last dose of neoadjuvant therapy in all study arms

Experimental: ACy followed by HPCT and atezolizumab
Patients will receive a combination of doxorubicin (A, 60 mg/m2 i.v.), cyclophosphamide (C, 600 mg/m2 i.v.) and atezolizumab (1200 mg i.v.) on day 1 every 3 week for 3 cycles. Subsequently they will be given trastuzumab on day 1 (H, at the loading dose of 8 mg/kg i.v. then 6 mg/kg i.v.), pertuzumab on day 1 (P, at the loading dose of 840 mg .v., then 420 mg i.v.), carboplatin (C) at AUC 2 i.v. on day 1 and day 8, paclitaxel (T) at 90 mg/m2 i.v. on day 1 and day 8, and atezolizumab 1200 mg i.v. on day 1 for 3 cycles every 3 weeks. Definite surgery will be performed not later than 4 weeks after the last dose of neoadjuvant therapy. Trastuzumab and pertuzumab will then be delivered for 15 additional cycles and atezolizumab for 12 additional cycles as adjuvant therapy.
Drug: Trastuzumab
Trastuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Herceptin

Drug: Pertuzumab
Pertuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Perjeta

Drug: Carboplatin
Carboplatin will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Carboplatin Hospiria

Drug: Paclitaxel
Paclitaxel will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Paclitaxel Hospiria

Drug: Doxorubicin
Adriamycin will be delivered i.v. on day 1 every 3 weeks in arm ACy followed by HPCT for the first 3 cycles
Other Name: Doxorubicin Pfizer

Drug: Cyclophosphamide
Cyclophosphamide will be given i.v. on day 1 every 3 weeks in arm ACy followed by HPCT and atezolizumab for the first 3 cycles
Other Name: Cyclophosphamide Sandoz

Drug: Atezolizumab
Atezolizumab will be given i.v. on day 1 every 3 weeks in arm ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Tecentriq

Procedure: Surgery
Breast cancer surgery (breast and axilla) either conservative or radical not later than 4 weeks from the last dose of neoadjuvant therapy in all study arms

Experimental: HPCT and atezolizumab
Patients will receive a combination of trastuzumab, pertuzumab, carboplatin, paclitaxel and atezolizumab as neoadjuvant therapy for 6 cycles every 3 weeks. Trastuzumab (H) will be delivered on day 1 at the dose of 8 mg/kg loading dose i.v., then 6 mg/kg i.v. Pertuzumab (P) will be delivered on day 1 at the dose of 840 mg loading dose i.v., then 420 mg i.v. Carboplatin (C) will be administered at AUC 2 i.v. on day 1 and day 8; paclitaxel (T) will be given at 90 mg/m2 i.v. on day 1 and day 8; atezolizumab at the dose of 1200 mg i.v. on day 1. Definite surgery will be performed not later than 4 weeks after the last dose of neoadjuvant therapy. Trastuzumab, pertuzumab and atezolizumab will then be delivered for 12 additional cycles as adjuvant therapy.
Drug: Trastuzumab
Trastuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Herceptin

Drug: Pertuzumab
Pertuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Perjeta

Drug: Carboplatin
Carboplatin will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Carboplatin Hospiria

Drug: Paclitaxel
Paclitaxel will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Paclitaxel Hospiria

Drug: Atezolizumab
Atezolizumab will be given i.v. on day 1 every 3 weeks in arm ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
Other Name: Tecentriq

Procedure: Surgery
Breast cancer surgery (breast and axilla) either conservative or radical not later than 4 weeks from the last dose of neoadjuvant therapy in all study arms




Primary Outcome Measures :
  1. Event Free Survival (EFS) [ Time Frame: 5 years after the randomization of the last patient ]
    Assess EFS (disease progression while on neoadjuvant therapy or disease recurrence after surgery) in the study arms


Secondary Outcome Measures :
  1. Pathological complete response (pCR) [ Time Frame: At surgery, an expected average of 26 weeks after the randomization of the last patients ]
    Assess the rate of pCR defined as absence of invasive cancer in both breast and axillary nodes (ypT0Tis ypN0)

  2. Clinical objective response [ Time Frame: Participants will be followed for the duration of neoadjuvant therapy, an expected average of 22 weeks ]
    Assess the rate of clinical response rate after neoadjuvant therapy

  3. Distant Event Free Survival (DEFS) [ Time Frame: 5 years after the randomization of the last patients ]
    Assess DEFS (defined as the occurrence of distant disease progression while on neoadjuvant therapy or distant disease recurrence after surgery) in the study arms

  4. Overall Survival (OS) [ Time Frame: 5 years after the randomization of the last patient ]
    Assess OS in all arms

  5. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Participants will be followed for up to 5 years from the last randomized patient ]
    Number of participants with adverse events and related grades in all arms



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:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients aged 18 years or older with early high-risk ((T1cN1; T2N1; T3N0) or locally advanced and inflammatory breast cancers (stage III A-C according to AJCC) suitable for neoadjuvant treatment
  2. Histologically confirmed unilateral invasive breast cancer
  3. HER2 positive disease according to ASCO/CAP guidelines 2013 [defined as IHC 3+ or ISH positive (by gene copy number or HER2 gene/CEP17 ratio of 2 or greater)]
  4. Known estrogen (ER) and progesterone receptor (PgR)
  5. Availability of a representative paraffin-embedded (FFPE) tumor block taken at diagnostic biopsy for central confirmation of HER2 eligibility, for assessment of ER, PgR, Ki67 and PD-L1 expression and for biomarker evaluation is mandatory. Note: the diagnostic biopsy of the breast lesion may have been taken before the required screening procedures. If diagnostic sentinel node biopsy if performed, an FFPE block must be available. An FFPE tumor block is also mandatory after the first cycle of therapy. Surgery tissue (residual tumor or tumor bed in case of pCR and axillary node material) is also mandatory.
  6. Consent to the collection of blood samples mandatorily before starting neoadjuvant treatment, after the first cycle of therapy, at the end of neoadjuvant treatment (before surgery), 6 months after surgery and at the end of all treatments.
  7. ECOG performance status 0 or 1
  8. For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of study drugs. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year. Barrier methods must always be supplemented with the use of a spermicide
  9. Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
  10. Willing and able to comply with the protocol

Exclusion Criteria:

  1. Evidence of bilateral breast cancer or metastatic disease (M1)
  2. Patients with HER2-negative defined as 0-1+ by immunohistochemistry or 2+ by immunohistochemistry without HER2 amplification by either In Situ Hybridization (ISH) or other amplification tests done locally are considered not eligible for the study
  3. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the last menstrual cycle
  4. Women with childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, for example abstinence, an intra-uterine device, or double barrier method of contraception
  5. Previous treatment with chemotherapy, hormonal therapy or an investigational drug for any type of malignancy
  6. Previous investigational treatment for any condition other than malignancy within 4 weeks of randomization date
  7. Administration of a live, attenuated vaccine within 4 weeks before Day 1 or anticipation that such a live attenuated vaccine will be required during the study
  8. Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervix cancer are generally eligible
  9. Pre-existing motor or sensory neuropathy of grade > 1 for any reason
  10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  11. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  12. Patients with prior allogeneic stem cell or solid organ transplantation
  13. History of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
  14. History of idiopathic pulmonary fibrosis (including bronchiolitis obliterans with organizing pneumonia) or evidence of active pneumonitis on screening chest computed tomography scan
  15. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
  16. History of HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen [anti-HBc] test) are eligible.

    Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay (PCR) is negative for HCV RNA

  17. Active tuberculosis
  18. Severe infections within 4 weeks prior to Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Signs or symptoms of significant infection within 2 weeks prior to Day 1
  19. Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
  20. Other serious illness or medical condition including: history of documented congestive cardiac failure; New York Heart Association (NYHA) Class II or greater CHF; angina pectoris requiring anti-anginal medication or unstable angina within 6 months prior to Day 1; evidence of transmural infarction on ECG; myocardial infarction stroke or transient ischemic attack (TIA) within 6 months prior to Day 1; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
  21. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drugs
  22. Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus
  23. Any of the following abnormal baseline hematological values:

    1. White blood count (WBC) < 2.5 x 109/L
    2. Absolute Neutrophil Count (ANC) < 1.5 x 109/L
    3. Lymphocyte count < 0.5 x 109/L
    4. Platelet count < 100 x 109/L
    5. Hemoglobin (Hb) < 10 g/dL
  24. Any of the following abnormal baseline laboratory tests

    1. Serum total bilirubin > 1.5 x ULN (upper limit of normal) (except for patients with clearly documented Gilbert's syndrome)
    2. Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.25 x ULN
    3. Alkaline phosphatase > 2.5xx ULN
    4. Serum creatinine > 1.5 x ULN
    5. INR and aPTT > 1.5 × ULN within 2 weeks prior to enrollment. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
  25. Baseline left ventricular ejection fraction (LVEF) < 50% by echocardiography or multi-gated scintigraphic scan (MUGA)
  26. Major surgical procedure within 28 days prior to Day 1 or anticipation of need for a major surgical procedure during the course of the study
  27. Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Day 1 or at any time during the study.

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 ClinicalTrials.gov identifier (NCT number): NCT03595592


Contacts
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Contact: Pinuccia Valagussa +39 02 870864 pinuccia.valagussa@fondazionemichelangelo.org
Contact: Irene Corradino +39 02 870864 irene.corradino@fondazionemichelangelo.org

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Locations
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Austria
Klinikum Klagenfurt am Wörthersee Abteilung für Innede Medizin und Hämatologie und internistische Onkologie Not yet recruiting
Klagenfurt am Wörthersee, Austria, 9020
Contact: Wofgang Eisterer, MD         
Krankenhaus der Barmherzigen Schwestern Not yet recruiting
Linz, Austria, 4010
Contact: Andreas Petzer, MD         
Universitätsklinikum St. Pölten Klinische Abteilung für Innere Medizin Not yet recruiting
St. Poelten, Austria, 3100
Contact: Petra Pichler, MD         
Klinische Abteilung für Allgemeine Gynäkologie und Gynäkologische Onkologie - Universitätsklinik für Frauenheilkunde Medizinische Universität Wien / AKH " Not yet recruiting
Wien, Austria, 1090
Contact: Christian Singer, MD         
Germany
Klinik für Gynäkologie am Campus Charité Mitte (CCM) Not yet recruiting
Berlin, Germany, 10113
Contact: Cornelia Liedtke, MD         
Department of Gynecology and Obstetrics, Marienhospital Not yet recruiting
Bottrop, Germany, 46236
Contact: Hans Christian Kolberg, MD         
Klinikum Coburg, Frauenklinik Not yet recruiting
Coburg, Germany, 96450
Contact: Mark Oliver Prange, MD         
St Johannes Hospital Not yet recruiting
Dortmund, Germany, 44137
Contact: Georg Kunz, MD         
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Universitätsklinikum Carl Gustav Carus Not yet recruiting
Dresden, Germany, 01307
Contact: Pauline Wimberger, MD         
Markus Krankenhaus - Klinik für Gynäkologie und Geburtshilfe Not yet recruiting
Frankfurt, Germany, 60431
Contact: March Thill, MD         
SRH Waldklinikum Not yet recruiting
Gera, Germany, 07548
Contact: Dirk Michael Zahm, MD         
Universitätsklinikum Greifswald, Frauenklinik Not yet recruiting
Greifswald, Germany, 17475
Contact: Antje Belau, MD         
Klinik und Poliklinik für Gynäkologie am Universitätsklinikum (Saale) Not yet recruiting
Halle (saale), Germany, 06120
Contact: Christoph Thomssen, MD         
Gynäkologisch-Onkologische Praxis Not yet recruiting
Hannover, Germany, 30177
Contact: Hans-Joachim Lück, MD         
NCT Nationales Zentrum für Tumorerkrankungen Gynäkologische Onkologie, Frauenklinik Not yet recruiting
Heidelberg, Germany, 69120
Contact: Andreas Schneeweiss, MD         
St. Marien-Klinik GmbH Frauenklinik der St. Vincentius-Kliniken gAG - Gynäkologisches Krebszentrum Karlsruhe - Brustzentrum Karlsruhe Not yet recruiting
Karlsruhe, Germany, 76135
Contact: Oliver Tomé, MD         
Städtisches Klinikum Magdeburg - Klinik für Allgemein - und Viszeralchirurgie Not yet recruiting
Magdeburg, Germany, 39130
Contact: Christoph Kahl, MD         
Am Schillerhain 1-8 Not yet recruiting
Marktredwitz, Germany, 95615
Contact: Maria Dietrich, MD         
Klinikum Nürnberg Nord Not yet recruiting
Nürnberg, Germany, 90419
Contact: Cosima Brucker, MD         
Onkologische Praxis Velbert Not yet recruiting
Velbert, Germany, 42551
Contact: Arnd Nusch, MD         
Marien Hospital Witten Not yet recruiting
Witten, Germany, 58452
Contact: John Hackmann, MD         
Italy
Ospedale Papa Giovanni XXIII Not yet recruiting
Bergamo, Italy, 24128
Principal Investigator: Elena Rota, MD         
Presidio Ospedaliero Di Summa-Perrino Not yet recruiting
Brindisi, Italy, 72100
Principal Investigator: Saverio Cinieri, MD         
Dipartimento di Oncologia Medica AUSL della Romagna Not yet recruiting
Faenza, Italy, 48018
Principal Investigator: Laura Amaducci, MD         
IST San Martino Not yet recruiting
Genova, Italy, 16132
Principal Investigator: Lucia Del Mastro, MD         
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori Not yet recruiting
Meldola, Italy, 47014
Principal Investigator: Andrea Rocca, MD         
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Principal Investigator: Mariani Gabriella, MD         
Istituto Europeo di Oncologia Not yet recruiting
Milano, Italy, 20141
Principal Investigator: Marco Colleoni, MD         
Ospedale Luigi Sacco Not yet recruiting
Milano, Italy, 20160
Principal Investigator: Anna Gambaro, MD         
Ospedale San Raffaele Recruiting
Milano, Italy
Principal Investigator: Luca Gianni, MD         
AO Universitaria Policlinico di Modena Not yet recruiting
Modena, Italy, 41124
Principal Investigator: Luca Moscetti, MD         
Ospedale Sacro Cuore - Don Calabria Recruiting
Negrar, Italy, 37024
Principal Investigator: Stefania Gori, MD         
Fondazione Salvatore Maugeri Recruiting
Pavia, Italy, 27100
Principal Investigator: Antonio Bernardo, MD         
Azienda Ospedaliero Universitaria Pisana Ospedale S. Chiara Not yet recruiting
Pisa, Italy, 56100
Principal Investigator: Andrea Michelotti, MD         
Arcispedale Santa Maria Nuova - A.O. Reggio Emilia Recruiting
Reggio Emilia, Italy, 42123
Principal Investigator: Giancarlo Bisagni, MD         
Ospedale Infermi AUSL della Romagna Recruiting
Rimini, Italy, 247900
Principal Investigator: Lorenzo Gianni, MD         
Istituto Nazionale Tumori - Regina Elena Recruiting
Roma, Italy, 00144
Principal Investigator: Alessandra Fabi, MD         
Ospedale Santa Maria della Misericordia Recruiting
Udine, Italy, 33100
Principal Investigator: Mauro Mansutti, MD         
Spain
Centro Oncologico de Galicia Recruiting
A Coruña, Spain, 15009
Contact: Manuel Ramos Vazquez, MD         
Hospital Virgen de Los Lirios Not yet recruiting
Alcoy, Spain, 03804
Contact: Amparo Oltra Ferrando, MD         
Hospital General Unv. Alicante Not yet recruiting
Alicante, Spain, 03010
Contact: Juan José Ponce Lorenzo, MD         
"Hospital Infanta Cristina de Badajoz (CICAB - Centro de Investigación Clínica del Área de Salud de Badajoz)" Recruiting
Badajoz, Spain, 06007
Contact: Juan Ignacio Delgado Mingorance, MD         
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 08025
Contact: Agusti Barnadas i Molins, MD         
Hospital Clinic Provincial Recruiting
Barcelona, Spain, 08036
Contact: Bárbara Adamo, MD         
Hospital del Mar - IMAS Not yet recruiting
Barcelona, Spain, Hospital del Mar - IMAS
Contact: Sonia Servitja Tormo, MD         
Hospital de Basurto Not yet recruiting
Bilbao, Spain, 48013
Contact: Elena Galve Calvo, MD         
Hospital San Pedro de Alcantara Not yet recruiting
Cáceres, Spain, 10003
Contact: Santiago González Santiago, MD         
Hospital Virgen de la Nieves Not yet recruiting
Granada, Spain, 18012
Contact: Verónica Conde Herrero, MD         
Hospital Juan Ramón Jimenez Not yet recruiting
Huelva, Spain, 21005
Contact: David Morales Pancorbo, MD         
Hospital Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Miguel Martín Jiménez, MD         
MD Anderson Cancer Center Not yet recruiting
Madrid, Spain, 28033
Contact: Laura García Estevez, MD         
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Contact: José Ángel García Sáenz, MD         
Hospital Unv. Fundación Jimenez Diaz Recruiting
Madrid, Spain, 28040
Contact: Yann Izarzugaza Peron, MD         
Hospital de Fuenlabrada Recruiting
Madrid, Spain, 28942
Contact: Diego Malón Giménez, MD         
Hospital General Universitario Morales Meseguer Not yet recruiting
Murcia, Spain, 30008
Contact: Elena Garcia Martínez, MD         
Complejo Hospitalario de Especialidades Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Contact: Alfonso Sánchez Muñoz, MD         
Clinica Universitaria de Navarra Not yet recruiting
Pamplona, Spain, 31008
Contact: Marta Santistebán Eslava, MD         
Complejo Hospitalario de Salamanca Not yet recruiting
Salamanca, Spain, 37007
Contact: César Rodríguez Sánchez, MD         
Hospital de Donostia Not yet recruiting
San Sebastián, Spain, 20014
Contact: Isabel Álvarez López, MD         
Hospital Onkologikoa Not yet recruiting
San Sebastián, Spain, 20014
Contact: Ainara Lahuerta, MD         
Hospital Clinico Unv. de Santiago Not yet recruiting
Santiago De Compostela, Spain, 15706
Contact: Rafael López López, MD         
Hospital Virgen de la Salud de Toledo Not yet recruiting
Toledo, Spain, 45004
Contact: José Ignacio Chacón López-Muñiz, MD         
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Begoña Bermejo De la Heras, MD         
Hospital Lozano Blesa Not yet recruiting
Zaragoza, Spain, 50009
Contact: Raquel Andrés Conejero, MD         
Hospital Miguel Servet Not yet recruiting
Zaragoza, Spain, 50009
Contact: Antonio 50009, MD         
Sponsors and Collaborators
Fondazione Michelangelo
Hoffmann-La Roche
Investigators
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Study Chair: Luca Gianni, MD Ospedale San Raffaele

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Responsible Party: Fondazione Michelangelo
ClinicalTrials.gov Identifier: NCT03595592     History of Changes
Other Study ID Numbers: FM-17-B01
2017-000981-31 ( EudraCT Number )
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione Michelangelo:
Unilateral, HER2 positive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Liposomal doxorubicin
Trastuzumab
Atezolizumab
Pertuzumab
Antibodies, Monoclonal
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