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. (see Contacts and Locations)
Verified August 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01437566
First received: September 8, 2011
Last updated: August 4, 2014
Last verified: August 2014

September 8, 2011
August 4, 2014
October 2011
November 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01437566 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Study of GDC-0941 or GDC-0980 With Fulvestrant Versus Fulvestrant in Advanced or Metastatic Breast Cancer in Patients Resistant to Aromatase Inhibitor Therapy
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: GDC-0941
    Repeating oral dose
  • Drug: placebo
    Repeating oral dose
  • Drug: fulvestrant
    Repeating intramuscular injection
  • Drug: GDC-0980
    Repeating oral dose
  • Experimental: D
    Interventions:
    • Drug: GDC-0941
    • Drug: fulvestrant
  • Placebo Comparator: E
    Interventions:
    • Drug: placebo
    • Drug: fulvestrant
  • Experimental: A
    Interventions:
    • Drug: fulvestrant
    • Drug: GDC-0941
  • Experimental: B
    Interventions:
    • Drug: fulvestrant
    • Drug: GDC-0980
  • Placebo Comparator: C
    Interventions:
    • Drug: fulvestrant
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Reference Study ID Number: GDC4950g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Argentina,   Australia,   Belgium,   Canada,   Chile,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   New Zealand,   Peru,   Russian Federation,   Singapore,   Spain,   Thailand,   United Kingdom
 
NCT01437566
GDC4950g, GO00769, 2010-023763-17
Not Provided
Genentech
Genentech
Not Provided
Study Director: Gallia Levy, M.D., Ph.D. Genentech
Genentech
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP