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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Placebo; Drug: GDC-0941; Drug: Paclitaxel

• Registration Number: NCT01740336
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-30
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Study Start: 2013-02-06
• Primary Completion: 2015-10-20
• Study Completion: 2015-12-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: Paclitaxel, Placebo	Placebo	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.
A: Paclitaxel, GDC-0941	GDC-0941	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.
A: Paclitaxel, GDC-0941	Paclitaxel	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.
B: Paclitaxel, Placebo	Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)	From the time of randomization until disease progression or death from any cause (up to approximately 3 years)

Secondary Outcome Measures

Name	Time	Method
Population PK for Paclitaxel	Day 1 of Cycle 1 (cycle length=28 days)
Percentage of Participants With Adverse Events	From randomization up to approximately 3 years
Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1	From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1	From first observation of an objective tumor response until disease progression (up to approximately 3 years)
Percentage of Participants Acheiving Clinical Benefit (Partial Response, Complete Response or Stable Disease Lasting for at Least 6 Months) Assessed as per Modified RECIST v1.1	From randomization until disease progression (up to approximately 3 years)
Population Pharmacokinetics (PK) for GDC-0941	Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)

Trial Locations

Locations (97)

Arizona Oncology Associates, PC - NAHOA; 🇺🇸 Sedona, Arizona, United States

Pacific Cancer Medical Center; 🇺🇸 Anaheim, California, United States

California Cancer Associates for Research & Excellence, Inc.; 🇺🇸 Encinitas, California, United States

Kaiser Permanente - Hayward; 🇺🇸 Hayward, California, United States

Kaiser Permanente - Oakland; 🇺🇸 Oakland, California, United States

Bay Area Cancer Research Group, LLC; 🇺🇸 Pleasant Hill, California, United States

Kaiser Permanente Medical Center - Roseville; 🇺🇸 Roseville, California, United States

Kaiser Permanente Sacramento Medical Center; 🇺🇸 Sacramento, California, United States

Kaiser Permanente - San Francisco (2238 Geary); 🇺🇸 San Francisco, California, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

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