Clinical study to assess safety and efficacy of Paclitaxel + GDC-0941 versus Paclitaxel + Placebo in metastatic breast cancer patients.

Phase 1

• Conditions: Metastatic Breast Cancer; MedDRA version: 18.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003262-41-GB
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-12
• Study Completion: 2015-12-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 179

Inclusion Criteria

• Age > 18
• Women with 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Prior non-capecitabine chemotherapy for locally recurrent or metastatic disease
•For patients who have received
- prior treatment with capecitabine in the metastatic setting, treatment must have been completed < 2 weeks prior to Cycle 1, Day 1.Prior treatment with a PI3K inhibitor for advanced breast cancer or MBC (including but not limited to GDC 0941, GDC 0980, BEZ235, BKM120, BYL719, LY294002, PIK-75, TGX-221, XL147, XL765, SF1126, PX-866, D 87503, D-106669, GSK615, CAL101)
Prior mTOR inhibitors (e.g., everolimus) are permitted provided treatment concluded at least 2 weeks prior to Cycle 1, Day 1.
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified