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

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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 participants with locally recurrent or metastatic breast cancer.

Key facts

Study ID

NCT01740336

Run by

Genentech, Inc.

People needed

183

Starts

2013-02-06

Expected to finish

2015-12-10

Last updated by the study team

2017-04-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 hormone receptor (HR) (estrogen receptor and/or progesterone receptor)-positive disease as defined by local guidelines
• Eastern Cooperative Oncology Group (ECOG) performance status of 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 less than (<) 1 percent (%) 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

You may not qualify if…

• Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
• Prior treatment with a phosphoinositide 3-kinase (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 due to current known active infection with human immunodeficiency virus (HIV) or due to the use of immunosuppressive therapies for other conditions
• Need for current chronic corticosteroid therapy
• Pregnant, lactating, or breastfeeding women
• Current severe, uncontrolled systemic disease
• Known untreated or active central nervous system (CNS) metastases

Where it is running

• Pacific Cancer Medical Center — Anaheim, California, United States
• California Cancer Associates for Research & Excellence, Inc. — Encinitas, California, United States
• Kaiser Permanente - Hayward — Hayward, California, United States
• Kaiser Permanente - Oakland — Oakland, California, United States
• Bay Area Cancer Research Group, LLC — Pleasant Hill, California, United States
• Kaiser Permanente Medical Center - Roseville — Roseville, California, United States
• Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
• Kaiser Permanente - San Francisco (2238 Geary) — San Francisco, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Kaiser Permanente - San Jose — San Jose, California, United States
• Kaiser Permanente - Santa Clara — Santa Clara, California, United States
• Kaiser Permanente - South San Francisco — South San Francisco, California, United States
• Kaiser Permanente - Vallejo — Vallejo, California, United States
• Kaiser Permanente - Walnut Creek — Walnut Creek, California, United States
• Helen & Harry Gray Cancer Center-Hartford Hospital-CCD PRIME; Research — Hartford, Connecticut, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Cancer Specialists of North Florida — Orange Park, Florida, United States
• Hematology - Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
• Phoebe Putney Memorial Hospital — Albany, Georgia, United States
• Joliet Oncology-Hematology; Associates, Ltd. — Joliet, Illinois, United States
• Oncology Specialists, S.C. — Park Ridge, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• Cotton-O'Neil Clinical Research Center, Hematology and Oncology; Cotton O'Neil Cancer Center — Topeka, Kansas, United States
• Hematology Oncology Clinic — Baton Rouge, Louisiana, United States
• Arizona Oncology Associates, PC - NAHOA — Sedona, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.