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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 180

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy (as measured by progression-free survival [PFS]) of paclitaxel + GDC-0941 versus paclitaxel + placebo in patients with and without PIK3CA mutations and in all treated patients;Secondary Objective: ?To evaluate the safety of paclitaxel + GDC-0941 versus paclitaxel + placebo<br>?To assess the clinical activity, as measured by response rate and duration of response, of paclitaxel + GDC-0941 versus paclitaxel + placebo in patients with and without PIK3CA mutations and in all treated patients<br>?To assess the prognostic and predictive effects of PIK3CA mutations on PFS<br>?To assess the population pharmacokinetics of GDC-0941 and paclitaxel when co-administered;Primary end point(s): Progression-free survival (PFS) in patients with and without PIK3CA tumor mutations, as well as in all treated patients as assessed by the investigator per modified RECIST version 1.1;Timepoint(s) of evaluation of this end point: Every 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary outcome measures in all treated patients and in patients with and without PIK3CA mutations are:<br>?Objective tumor response as assessed by investigator per modified RECIST v1.1 <br>?Clinical benefit, defined as partial response (PR), complete response (CR), or stable disease (SD), lasting for at least 6 months (i.e., 26 weeks);Timepoint(s) of evaluation of this end point: Every 12 weeks

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