Phase III, randomized, multicenter, multinational, open label study in patients with HER2-positive primary breast cancer following neoadjuvant chemotherapy and surgery.

Conditions: HER2-positive primary breast cancer.
MedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 100000004864
MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-002018-37-ES

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 1484

Inclusion Criteria

? Adult patients, aged at least 18 years
? Histologically confirmed invasive breast cancer with clinical staging T1-4, N0-3, M0 (no metastasis)
? HER2-positive tumor as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization)
? Patients must have received at least 6 cycles with 16 weeks of prior chemotherapy in the preoperative (neoadjuvant) setting including at least 9 weeks of a taxane and 9 weeks of HER2-directed therapy which may be given concurrently
? Surgical removal of all clinically-evident disease in the breast and lymph nodes
? Pathologic evidence of residual invasive cancer following completion of preoperative chemotherapy
? ECOG performance status of 0 or 1
? Life expectancy of at least 6 months from the first dose of study treatment
? Adequate organ function as determined by the following laboratory results, within 14 days prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 284

Exclusion Criteria

? Metastatic breast cancer
? History of any prior breast cancer except for lobular carcinoma in situ
? Treatment with a cumulative dose of epirubicin greater than 480mg/m2 or any other anthracycline like doxirubicin greater than 240mg/m2
? Treatment with any investigational anticancer drug within 28 days prior to commencing study treatment
? History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome
? Peripheral neuropathy greater or equal to Grade 2
? Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, angina, serious cardiac arrhythmia)
? Myocardial infarction within 12 months prior to randomization
? Active liver disease like hepatitis
? Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers)
? For female patients, current pregnancy or lactation
? Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
? Currrent, serious, uncontrolled Infections or known infection with HIV.