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

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ClinicalTrials.gov Identifier: NCT01740336
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: GDC-0941 Drug: Placebo Drug: Paclitaxel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Study of Paclitaxel With GDC-0941 Versus Paclitaxel With Placebo in Patients With Locally Recurrent or Metastatic Breast Cancer
Actual Study Start Date : February 6, 2013
Actual Primary Completion Date : October 20, 2015
Actual Study Completion Date : December 10, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: A: Paclitaxel, 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.
 Drug: GDC-0941
GDC-0941 will be administered QD orally for 5 consecutive days each week.

Drug: Paclitaxel
Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
Placebo Comparator: B: Paclitaxel, 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.
 Drug: Placebo
Placebo matching to GDC-0941

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740336


Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01740336    
Other Study ID Numbers: GO28509
2012-003262-41 ( EudraCT Number )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action