A Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | February 2013 |
End Date: | June 2016 |
Contact: | Reference Study ID Number: GO28509 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global.rochegenentechtrials@roche.com |
Phone: | 888-662-6728 (U.S. Only) |
A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
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.
the efficacy and safety of paclitaxel with GDC-0941 versus paclitaxel with placebo in
patients with locally recurrent or metastatic breast cancer.
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
We found this trial at
48
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