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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

NCT01817452

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: WSG-AM06 / ADAPT HER2+/HR-
  • NCT ID: NCT01817452

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
TrastuzumabHerceptinArm A
PertuzumabArm A
PaclitaxelArm B

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalTrastuzumab + Pertuzumab
  • Trastuzumab
  • Pertuzumab
Arm BActive ComparatorTrastuzumab + Pertuzumab + Paclitaxel
  • Trastuzumab
  • Pertuzumab
  • Paclitaxel

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:pCR will be measured after 12 weeks of randomized treatment.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:West German Study Group

Last Updated

May 18, 2015