A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: 5-Fluorouracil; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Paclitaxel; Pertuzumab; Placebo; Trastuzumab
Intervention description: 5-Fluorouracil will be administered as per the schedule specified in the respective arm.; Carboplatin will be administered as per the schedule specified in the respective arm.; Cyclophosphamide will be administered as per the schedule specified in the respective arm.; Docetaxel will be administered as per the schedule specified in the respective arm.; Doxorubicin will be administered as per the schedule specified in the respective arm.; Epirubicin will be administered as per the schedule specified in the respective arm.; Paclitaxel will be administered as per the schedule specified in the respective arm.; Pertuzumab will be administered as per the schedule specified in the respective arm.; Placebo will be administered as per the schedule specified in the respective arm.; Trastuzumab will be administered as per the schedule specified in the respective arm.
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Carboplatin; Doxorubicin; Fluorouracil; Trastuzumab; Epirubicin; Pertuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4804.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and
      efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in
      participants with operable HER2-positive primary breast cancer. This study will be carried
      out in collaboration with the Breast International Group (BIG).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is
             histologically confirmed, and adequately excised

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
             (</=) 1

          -  Known hormone receptor status (estrogen receptor and progesterone receptor)

          -  The interval between definitive surgery for breast cancer and the first dose of
             chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy
             must be administered within 7 days of randomization or on Day 56, whichever occurs
             first

          -  Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55
             percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA)
             Scan

          -  Confirmed HER2 positive status

          -  Completion of all necessary baseline laboratory and radiologic investigations prior to
             randomization

          -  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 participant 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 primary tumor/regional lymph nodes/distant
             metastasis (TNM), including inflammatory breast cancer

          -  Any node-negative tumor

          -  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

          -  Other concurrent serious diseases that may interfere with planned treatment including
             severe pulmonary conditions/illness

          -  Abnormal laboratory tests immediately prior to randomization

          -  Pregnant or lactating women

          -  Sensitivity to any of the study medications or any of the ingredients or excipients of
             these medications