breast cancer HER-2 positive breast cancer
Conditions
Interventions
Chemotherapy regimen (3-8 cycles) consist of two different regimens. 1. 
Anthracyclin-based regimen implicates 3 to 4 cycles of FEC (5-fluorouacil 
500-600 mg/m2, epirubicin 90-120mg/m2, cyclophosphamide 500-600 mg/m2) followed 
by 3 to 4 cycles of TH (docetaxel 100mg/m2, paclitaxel 80mg/m2, trastuzumab 
8mg/kg). 2. Anti-anthracyclin-based regimen consist of TCH (Docetaxel 75mg/m2, 
Carboplatin AUC 6, trastuzumab 8mg/kg. For details of these regimes, please see 
page 6 and 7 of the protocol BIG 4-11/BO25126/TOC4939G. Study medication 
(pertuzumab) starts parallel with taxane administration during chemotherapy. 
Pertuzumab will be loaded at 840 mg IV and followed by 420 mg IV 3-weekly 
cycles.
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult patients. >/= 18 years of age - Non-metastatic primary invasive HER2-positive carcinoma of the breast that is adequately excised, and that is either node-positive (except T0), or node-negative but with presence of at least one risk factor as defined by the protocol (the latter option only applies to protocol version A. Node-negative patients are NOT allowable under protocol version B.) - Eastern Cooperative Oncology Group (ECOG) performance status - The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). All procedures, including randomization, must occur during this period. The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first - Known hormone receptor status (estrogen receptor and progesterone receptor) - Baseline LVEF >= 55% - Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the patient and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug
Exclusion criteria
Exclusion criteria: - History of any prior (ipsi- and/or contralateral) invasive breast cancer; - History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin - Any clinical T4 tumor as defined by TNM, including inflammatory breast cancer - Any previous systemic chemotherapy for cancer or radiotherapy for cancer; - Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer- Concurrent anti-cancer treatment in another investigational trial - Serious cardiac or cardiovascular disease or condition - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is IDFS and is defined as the time between randomization and the date of first occurence of an IDFS event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare invasive disease-free survival including second non-breast cancers, disease-free survival (DFS), overall survival (OS), recurrence-free survival (RFI), distant recurrence-free interval (DRFI), cardiac safety, overall safety and health-related quality of life (HRQL) in the two treatment arms. | — |
Countries
Netherlands
Outcome results
None listed