This trial is active, not recruiting.

Condition breast cancer
Treatments gdc-0941, placebo, paclitaxel
Phase phase 2
Target PI3K
Sponsor Genentech, Inc.
Start date February 2013
End date June 2015
Trial size 197 participants
Trial identifier NCT01740336, 2012-003262-41, GO28509


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
orally daily for 5 consecutive days each week, followed by 2 days during which GDC-0941 is not administered (5/7-day schedule)
90 mg/m2 IV weekly for 3 out of 4 weeks in every 28-day cycle
(Active Comparator)
matching GDC-0941 placebo orally, 5/7-day schedule
90 mg/m2 IV weekly for 3 out of 4 weeks in every 28-day cycle

Primary Outcomes

Progression-free survival (PFS), defined as time from randomization to disease progression (tumor assessments according to RECIST v.1.1 criteria) or death from any cause
time frame: approximately 3.5 years

Secondary Outcomes

Safety: Incidence of adverse events
time frame: approximately 3.5 years
Objective tumor response rate
time frame: approximately 3.5 years
Clinical benefit rate, defined as partial response, complete response or stable disease lasting at least 6 months
time frame: approximately 3.5 years
Duration of confirmed objective response
time frame: approximately 3.5 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Genentech, Inc..