Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

5-Fluorouracil

5-Fluorouracil will be administered as per the schedule specified in the respective arm.

drug

Carboplatin

Carboplatin will be administered as per the schedule specified in the respective arm.

drug

Cyclophosphamide

Cyclophosphamide will be administered as per the schedule specified in the respective arm.

drug

Docetaxel

Docetaxel will be administered as per the schedule specified in the respective arm.

drug

Doxorubicin

Doxorubicin will be administered as per the schedule specified in the respective arm.

drug

Epirubicin

Epirubicin will be administered as per the schedule specified in the respective arm.

drug

Paclitaxel

Paclitaxel will be administered as per the schedule specified in the respective arm.

drug

Pertuzumab

Pertuzumab will be administered as per the schedule specified in the respective arm.

drug

Placebo

Placebo will be administered as per the schedule specified in the respective arm.

drug

Trastuzumab

Trastuzumab will be administered as per the schedule specified in the respective arm.

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

5-Fluorouracil

Carboplatin

Cyclophosphamide

Docetaxel

Doxorubicin

Epirubicin

Paclitaxel

Pertuzumab

Placebo

Trastuzumab

Ubicaciones

Centro Medico San Roque

Patrocinadores