A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
Stopped early · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02569801
- Run by
- Genentech, Inc.
- People needed
- 71
- Starts
- 2015-12-04
- Expected to finish
- 2020-02-28
- Last updated by the study team
- 2021-04-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yale Cancer Center — New Haven, Connecticut, United States
- Florida Cancer Specialists-Broadway, Fort Myers — Fort Myers, Florida, United States
- Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) — St. Petersburg, Florida, United States
- Oncology Hematology Care Inc — Cincinnati, Ohio, United States
- Tennessee Oncology PLLC — Franklin, Tennessee, United States
- The Center for Cancer and Blood Disorders - Fort Worth — Fort Worth, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
- Port Macquarie Base Hospital — Port Macquarie, New South Wales, Australia
- Adelaide Cancer Centre — Kurralta Park, South Australia, Australia
- Royal Hobart Hospital; Medical Oncology — Hobart, Tasmania, Australia
- Footscray Hospital — Footscray, Victoria, Australia
- Peninsula and South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia
- Epworth HealthCare; Clinical Trials Centre — Richmond, Victoria, Australia
- Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden — Dresden, Germany
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
- Praxisklinik für Hämatologie und Onkologie Dres. Köppler/Heymans/Weide/Thomalla — Koblenz, Germany
- HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe — Krefeld, Germany
- Rotkreuzklinikum München; Frauenklinik — München, Germany
- Universitätsklinikum Tübingen — Tübingen, Germany
- Marien Hospital Witten Gemeinnützige GmbH — Witten, Germany
- Kyungpook National University Medical Center — Daegu, South Korea
- National Cancer Center — Goyang-si, South Korea
- Samsung Medical Center — Seoul, South Korea
- Severance Hospital, Yonsei University Health System — Seoul, South Korea
Full record on ClinicalTrials.gov
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