A Study of Pertuzumab in Addition to Chemotherapy and Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With HER2-Positive Primary Breast Cancer

• Conditions: Patients with operable HER2-positive primary breast cancer; MedDRA version: 17.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022902-41-GB
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-19
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 4800

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
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 4080
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 720

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified