Breast Cancer Clinical Trial
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
Summary
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.
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
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There are 44 Locations for this study
New Haven Connecticut, 06520, United States
Fort Myers Florida, 33908, United States
Saint Petersburg Florida, 33705, United States
Cincinnati Ohio, 45242, United States
Franklin Tennessee, 37067, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Darlinghurst New South Wales, 2010, Australia
Port Macquarie New South Wales, 2444, Australia
Kurralta Park South Australia, 5037, Australia
Hobart Tasmania, 7000, Australia
Footscray Victoria, 3011, Australia
Frankston Victoria, 3199, Australia
Richmond Victoria, 3121, Australia
Dresden , 01307, Germany
Hamburg , 20246, Germany
Koblenz , 56068, Germany
Krefeld , 47805, Germany
Muenchen , 80637, Germany
Tuebingen , 72076, Germany
Witten , 58452, Germany
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seoul , (0)63, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 08308, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Barcelona Cantabria, 08036, Spain
A Coruña LA Coruña, 15006, Spain
Lleida Lerida, 25198, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Valencia , 46010, Spain
Brighton , BN2 5, United Kingdom
Edinburgh , EH4 2, United Kingdom
London , EC1A , United Kingdom
London , N7 9N, United Kingdom
London , W1G 6, United Kingdom
Macclesfield , SK10 , United Kingdom
Nottingham , NG5 1, United Kingdom
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