A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer

Status: Recruiting
Diagnosis: Breast: Metastatic
NCT ID: NCT01740336 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-105


This multicenter, randomized, single-blind, placebo-controlled, two arm study will evaluate the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer.


Conducting Institutions:
Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Ian Krop, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Steven Come, MD, Beth Israel Deaconess Medical Center

Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

Inclusion Criteria: - Female adult patients - Histologically or cytologically confirmed adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease - Human epidermal growth factor receptor 2 (HER2)-negative and HR (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Adequate hematologic and end organ function - Women of childbearing potential must agree to remain abstinent or to use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 30 days after the last dose of study treatment or 6 months after discontinuation of paclitaxel, whichever is longer Exclusion Criteria: - Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease - Prior treatment with a PI3K inhibitor for advanced or metastatic breast cancer - History of intolerance to a taxane-containing therapy - History of clinically significant cardiac or pulmonary dysfunction - History of malabsorption syndrome or other condition that would interfere with enteral absorption - Clinically significant history of liver disease - Active autoimmune disease or active inflammatory disease - Immunocompromised status - Need for current chronic corticosteroid therapy - Pregnancy, lactation, or breastfeeding - Current severe, uncontrolled systemic disease - Known untreated or active central nervous system (CNS) metastases
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