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.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| Fulvestrant | | Fulvestrant |
| GDC-0810 | RO7056118 | GDC-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
| Name | Type | Description | Interventions |
|---|
| Fulvestrant | Active Comparator | Participants 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. | |
| GDC-0810 | Experimental | Participants 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. | |
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: | Terminated |
| Lead Sponsor: | Genentech, Inc. |
Last Updated
March 23, 2020
