Breast Cancer
Conditions
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.
Interventions
DRUGGDC-0941
GDC-0941 will be administered QD orally for 5 consecutive days each week.
DRUGPlacebo
Placebo matching to GDC-0941
DRUGPaclitaxel
Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| Percentage of Participants With Adverse Events | From randomization 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) |
| Population PK for Paclitaxel | Day 1 of Cycle 1 (cycle length=28 days) |
| 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) |
Countries
Australia, Austria, Belgium, Czechia, South Korea, Spain, United Kingdom, United States
Outcome results
None listed