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A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol (ADAPT)

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ClinicalTrials.gov Identifier: NCT01817452
Recruitment Status : Recruiting
First Posted : March 25, 2013
Last Update Posted : May 19, 2015
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
West German Study Group

Brief Summary:
Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without chemotherapy backbone within the ADAPT trial.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Trastuzumab Drug: Pertuzumab Drug: Paclitaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol
Study Start Date : March 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A
Trastuzumab + Pertuzumab
Drug: Trastuzumab
Other Name: Herceptin

Drug: Pertuzumab
Active Comparator: Arm B
Trastuzumab + Pertuzumab + Paclitaxel
Drug: Trastuzumab
Other Name: Herceptin

Drug: Pertuzumab
Drug: Paclitaxel



Primary Outcome Measures :
  1. Definition of a biomarker (profile) characterizing "good responders" to dual blockade T and P anti-HER2 blockade that have similar pCR rates as patients treated with identical dual anti-HER2 blockade + taxane backbone [ Time Frame: After 12 weeks of therapy ]
    pCR will be measured after 12 weeks of randomized treatment.



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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:

  • Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
  • Histologically confirmed unilateral primary invasive carcinoma of the breast
  • Clinical T1 - T4 (except inflammatory breast cancer)
  • All clinical N (cN)
  • No clinical evidence for distant metastasis (M0)
  • Known HR status and HER2 status (local pathology) Tumor block available for central pathology review
  • Performance Status ECOG ≤ 1 or KI ≥ 80%
  • Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
  • Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
  • The patient must be accessible for treatment and follow-up

Additional Inclusion criteria for participation in the HR-/HER2+ sub-protocol:

  • Confirmed ER and PR negative and HER2+ by central pathology
  • Clinical cT1c - T4a-c (participation of patients with tumors >cT2 is strongly recommended)
  • All clinical N (participation of patients with cN0, if at least cT1c is strongly recommended)
  • Patients must qualify for neoadjuvant treatment
  • LVEF > 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)

Exclusion Criteria:

  • Known hypersensitivity reaction to the compounds or incorporated substances
  • Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
  • Non-operable breast cancer including inflammatory breast cancer
  • Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
  • Male breast cancer
  • Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
  • Breast feeding woman
  • Sequential breast cancer
  • Reasons indicating risk of poor compliance Patient not able to consent

Additional Exclusion Criteria for participation in the HER2+/HR- sub-protocol:

  • Known polyneuropathy ≥ grade 2
  • Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
  • Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.)
  • Uncompensated cardiac function (current unstable ventricular arrhythmia requiring treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial infarction or unstable angina pectoris within 6 months of enrollment, history of severe hypertension, CAD - coronary artery disease)
  • Severe dyspnea
  • Abnormal blood values:
  • Thrombocytopenia > CTCAE grade 1
  • Increases in ALT/AST > CTCAE grade 1
  • Hypokalaemia > CTCAE grade 1
  • Neutropenia > CTCAE grade 1
  • Anaemia > CTCAE grade 1

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): NCT01817452


Contacts
Contact: Nadia Harbeck, Prof. Dr. +49216156623 ext 10 Nadia.Harbeck@med.uni-muenchen.de

Locations
Germany
Ev. Krankenhaus Bethesda Brustzentrum Niederrhien Recruiting
Moenchengladbach, Germany, 41061
Contact: Ulrike Nitz, Prof. Dr.    +492161981 ext 2330    ulrike.nitz@wsg-online.com   
Principal Investigator: Raquel von Schumann, Dr.         
Sponsors and Collaborators
West German Study Group
Roche Pharma AG
Investigators
Principal Investigator: Nadia Harbeck, Prof. Dr. Breast Center of the University of Munich (LMU), Universitätsfrauenklinik Großhadern, Munich, Germany
Study Chair: Ulrike Nitz, Prof. Dr. Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

Publications:
Responsible Party: West German Study Group
ClinicalTrials.gov Identifier: NCT01817452     History of Changes
Other Study ID Numbers: WSG-AM06 / ADAPT HER2+/HR-
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Pertuzumab
Taxane
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action