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

Genentech

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: GDC-0941; Drug: Paclitaxel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01740336

GO28509

2012-003262-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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183 participants in 2 patient groups, including a placebo group

A: Paclitaxel, GDC-0941

Experimental group

Description:

Participants will receive GDC-091 260 milligrams (mg) orally in repeated rounds of once daily (QD) dosing for 5 consecutive days followed by 2 consecutive days during which GDC-0941 will not be administered (5/7-day schedule). This 5/7-day schedule will be repeated weekly in each 28-day cycle until disease progression or intolerable toxicity. Participants will receive 90 milligrams per square meter (mg/m\^2) intravenously (IV) weekly for 3 out of 4 weeks in every 28-day cycle.

Treatment:

Drug: Paclitaxel

Drug: GDC-0941

B: Paclitaxel, Placebo

Placebo Comparator group

Description:

Participants will receive placebo matching to GDC-0941 on the 5/7-day schedule along with 90 mg/m\^2 IV weekly for 3 out of 4 weeks in every 28-day cycle.

Treatment:

Drug: Paclitaxel

Drug: Placebo