A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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

- 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy variable is IDFS and is defined as the time between<br /><br>randomization and the date of first occurence of an IDFS event. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Compare invasive disease-free survival including second non-breast cancers,<br /><br>disease-free survival (DFS), overall survival (OS), recurrence-free survival<br /><br>(RFI), distant recurrence-free interval (DRFI), cardiac safety, overall safety<br /><br>and health-related quality of life (HRQL) in the two treatment arms.</p><br>