Clinical Trials /

A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy

NCT02569801

Description:

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
  • Official Title: A Phase II, Open-Label, Randomized Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic ER+ /HER2- Breast Cancer Resistant to Aromatase Inhibitor Therapy

Clinical Trial IDs

  • ORG STUDY ID: GO29689
  • SECONDARY ID: 2015-000106-19
  • NCT ID: NCT02569801

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
FulvestrantFulvestrant
GDC-0810RO7056118GDC-0810

Purpose

The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to AI therapy. The development of GDC-0810 has been halted by the Sponsor and the enrollment in this study has been discontinued. Participants currently enrolled in the study who are experiencing clinical benefit may continue receiving GDC-0810 as a single agent or fulvestrant until disease progression (PD), unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of the study by the Sponsor.

Trial Arms

NameTypeDescriptionInterventions
FulvestrantActive ComparatorParticipants will receive 500 milligrams (mg) of fulvestrant as two intramuscular injections (250 mg each) on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
  • Fulvestrant
GDC-0810ExperimentalParticipants will receive three 200 mg tablets (total dose = 600 mg) of GDC-0810 orally once daily until disease progression, unmanageable toxicity, withdrawal of consent, exhaustion of GDC-0810 drug supply, or termination of study by the Sponsor.
  • GDC-0810

Eligibility Criteria

        Inclusion Criteria:

          -  Postmenopausal women with histologically or cytologically confirmed invasive, ER+/HER-
             (defined by local guidelines) metastatic or inoperable, locally advance breast cancer

          -  Participants for whom endocrine therapy is recommended and treatment with cytotoxic
             chemotherapy is not indicated at time of entry into the study

          -  Participants must have measurable disease by RECIST v1.1 or non-measurable, evaluable
             disease with atleast one evaluable bone lesion by RECIST v1.1 based on radiologic
             scans within 28 days of Day 1 of Cycle 1

          -  Participants with radiologic/objective evidence of breast cancer recurrence or
             progression while on or within 6 months after the end of adjuvant treatment with an
             AI, or progression while on or within 1 month after the end of prior AI treatment for
             locally advanced or metastatic breast cancer

        Exclusion Criteria:

          -  HER2-positive disease

          -  Prior treatment with fulvestrant

          -  Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen or >2 endocrine
             therapies for advanced or metastatic disease
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population
Time Frame:From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months)
Safety Issue:
Description:
Measure:Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1
Time Frame:From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Safety Issue:
Description:
Measure:Duration of Response (DOR) Assessed Using RECIST v1.1
Time Frame:From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Safety Issue:
Description:
Measure:Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1
Time Frame:From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Safety Issue:
Description:
Measure:Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame:From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months)
Safety Issue:
Description:
Measure:Apparent Oral Clearance (CL/F) of GDC-0810
Time Frame:Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days
Safety Issue:
Description:
Measure:Apparent Volume of Distribution (Vz/F) of GDC-0810
Time Frame:Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days
Safety Issue:
Description:
Measure:Absorption Rate Constant (Ka) of GDC-0810
Time Frame:Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Genentech, Inc.

Last Updated

January 15, 2018