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Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy

This study is currently recruiting participants.
Verified May 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01437566
First received: September 8, 2011
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a multicenter, international, randomized, double-blinded, placebo-controlled, Phase II trial. Patients with advanced or Metastatic Breast Cancer (MBC) who have previously received treatment with an aromatase inhibitor. Patients will receive treatment with GDC-0941 + fulvestrant or GDC-0980 + fulvestrant or placebo + fulvestrant.


Condition Intervention Phase
Breast Cancer
 Drug: fulvestrant
Drug: GDC-0941
Drug: GDC-0980
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Placebo Controlled, Randomized Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy

Resource links provided by NLM:

Drug Information available for: Fulvestrant
U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival (PFS) as assessed by the investigator per modified RECIST version 1.1 [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective tumor response as assessed by the investigator per modified RECIST v1.1 [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Clinical benefit defined as partial response (PR), complete response (CR), or stable disease (SD) per modified RECIST v1.1 [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Duration of confirmed objective response as assessed by the investigator per modified RECIST v1.1 [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Proportion of patients with PIK3CA mutant tumors [ Time Frame: until disease progression, up to 1 year ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0941 and GDC-0980: time to maximum concentration [ Time Frame: Cycle 1, Day 15/16; Cycle 2, Day 15; Cycle, 6 Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0941 and GDC-0980: maximum concentration [ Time Frame: Cycle 1, Day 15/16; Cycle 2, Day 15; Cycle, 6 Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of GDC-0941 and GDC-0980: Area under the concentration time curve [ Time Frame: Cycle 1, Day 15/16; Cycle 2, Day 15; Cycle, 6 Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: fulvestrant
Repeating intramuscular injection
Drug: GDC-0941
Repeating oral dose
Experimental: B Drug: fulvestrant
Repeating intramuscular injection
Drug: GDC-0980
Repeating oral dose
Placebo Comparator: C Drug: fulvestrant
Repeating intramuscular injection
Drug: placebo
Repeating oral dose
Experimental: D Drug: fulvestrant
Repeating intramuscular injection
Drug: GDC-0941
Repeating oral dose
Placebo Comparator: E Drug: fulvestrant
Repeating intramuscular injection
Drug: placebo
Repeating oral dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ER-positive locally advanced breast cancer or Metastatic Breast Cancer (MBC). Postmenopausal women with locally advanced breast cancer or Metastatic Breast Cancer whose disease has progressed during or after treatment with an aromatase inhibitor. Part II: Postmenopausal women with locally advanced PIK3CA-mutant breast cancer or PIK3CA-mutant MBC that has progressed during or after treatment with an AI.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Patients must have measurable disease by RECIST v1.1 or bone-only disease
  • Adequate hematologic and end-organ function
  • Estrogen receptor-positive disease and HER2-negative disease

Exclusion Criteria:

  • Prior treatment with fulvestrant, PI3K inhibitor, or mTOR inhibitor for advanced breast cancer or MBC
  • Prior treatment with > one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for metastatic breast cancer
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption
  • History of clinically significant cardiac or pulmonary dysfunction
  • Clinically significant history of liver disease
  • Active uncontrolled autoimmune disease or active inflammatory disease
  • Immunocompromised status
  • Symptomatic hypercalcemia
  • Need for current chronic corticosteroid therapy
  • Pregnancy, lactation, or breastfeeding
  • Known untreated or active central nervous system (CNS) metastases Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437566

Contacts
Contact: Reference Study ID Number: GDC4950g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 136 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Gallia Levy, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01437566     History of Changes
Other Study ID Numbers: GDC4950g, GO00769, 2010-023763-17
Study First Received: September 8, 2011
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013