A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | December 4, 2015 |
| End Date: | March 28, 2020 |
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
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.
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.
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
We found this trial at
8
sites
1201 5th Avenue North
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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