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Completed

NCT Number: NCT01740336

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0941

Drug

GDC-0941 will be administered QD orally for 5 consecutive days each week.

Placebo

Drug

Placebo matching to GDC-0941

paclitaxel

Drug

Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.

Primary outcomes

  1. Progression-Free Survival (PFS) Assessed as per Modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

    Time frame: From the time of randomization until disease progression or death from any cause (up to approximately 3 years)

Secondary outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: From randomization up to approximately 3 years

  2. Percentage of Participants With Objective Tumor Response Assessed as per Modified RECIST v1.1

    Time frame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)

  3. 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

    Time frame: From randomization until disease progression (up to approximately 3 years)

  4. Duration of Confirmed Objective Response Assessed as per Modified RECIST v1.1

    Time frame: From first observation of an objective tumor response until disease progression (up to approximately 3 years)

  5. Population Pharmacokinetics (PK) for GDC-0941

    Time frame: Day 8 of Cycle 1 and Day 1 of Cycle 6 (cycle length=28 days)

  6. Population PK for Paclitaxel

    Time frame: Day 1 of Cycle 1 (cycle length=28 days)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2012
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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