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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT01817452

Studienbeginn:
März 2014

Letztes Update:
24.03.2023

Wirkstoff:
Trastuzumab, Pertuzumab, Paclitaxel

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
West German Study Group

Collaborator:
Roche Pharma AG

Studienleiter

Nadia Harbeck, Prof. Dr.
Principal Investigator
Breast Center of the University of Munich (LMU), Universitätsfrauenklinik Großhadern, Munich, Germany

Ulrike Nitz, Prof. Dr.
Study Chair
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

Kontakt

Michael Staedele
Kontakt:
Phone: +49216156623
Phone (ext.): 10
E-Mail: wsg@wsg-online.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Ev. Krankenhaus Bethesda Brustzentrum Niederrhien
41061 Moenchengladbach
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ulrike Nitz, Prof. Dr.
Phone: +492161981
Phone (ext.): 2330
E-Mail: ulrike.nitz@wsg-online.com» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without

chemotherapy backbone within the ADAPT trial.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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.

Studien-Arme

Experimental: Arm A
Trastuzumab + Pertuzumab
Active Comparator: Arm B
Trastuzumab + Pertuzumab + Paclitaxel

Geprüfte Regime

Trastuzumab (Herceptin)
Pertuzumab
Paclitaxel

Quelle: ClinicalTrials.gov

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