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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
Overall Recruitment Status: Enrollment complete
 
Official Title
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
 
Region Sponsors
California - Northern
Hoffmann-La Roche
 
Acronym NCT No.
NCT01358877
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
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. After surgery, participants will be randomized to receive either pertuzumab or placebo intravenously (IV) every 3 weeks (q3w) for one year, along with 6-8 cycles of chemotherapy and 1 year of trastuzumab IV every 3 weeks. This study will be carried out in collaboration with the Breast International Group (BIG).
 
Detailed Description
 
 
 
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
  • 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
  • Known hormone receptor status (estrogen receptor and progesterone receptor)
  • Baseline LVEF greater than or equal to (>=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
  • Confirmed HER2 positive status
  • 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 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
 
Keywords and/or Specific Medical Conditions
  • Alkylating Agents
  • Immunologic Factors
  • Antibiotics, Antineoplastic
  • Immunosuppressive Agents
  • Antimitotic Agents
  • Mitosis Modulators
  • Antineoplastic Agents
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents, Alkylating
  • Myeloablative Agonists
  • Antineoplastic Agents, Phytogenic
  • Neoplasms
  • Antirheumatic Agents
  • Neoplasms by Site
  • BO25126
  • Paclitaxel
  • Breast Cancer
  • Pertuzumab
  • Breast Diseases
  • Physiological Effects of Drugs
  • Breast Neoplasms
  • Skin Diseases
  • Carboplatin
  • Topoisomerase II Inhibitors
  • Cyclophosphamide
  • Topoisomerase Inhibitors
  • Docetaxel
  • Trastuzumab
  • Doxorubicin
  • Tubulin Modulators
  • Epirubicin
  • Oncology (Adult)
  • Fluorouracil
 
KP Clinical Facility
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Suga, MD
Contact Information:
- Desiree Goldstein
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


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