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A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

approximately 3.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GO28509

NCT ID:

NCT01740336

Start Date:

February 2013

Completion Date:

August 2016

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Great Falls, Montana  59405
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Kansas City, Kansas  66160
Scarborough, Maine  04074
Omaha, Nebraska  68114
Metairie, Louisiana  70006
Denver, Colorado  
Boston, Massachusetts  
Charleston, South Carolina  
Salt Lake City, Utah  84112