A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
NCT ID: NCT02569801
Last Updated: 2021-04-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
71 participants
INTERVENTIONAL
2015-12-04
2020-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fulvestrant
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.
Fulvestrant
Fulvestrant at a dose of 500 mg as two intramuscular injections will be administered on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle.
GDC-0810
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.
GDC-0810
GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.
Interventions
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Fulvestrant
Fulvestrant at a dose of 500 mg as two intramuscular injections will be administered on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle.
GDC-0810
GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prior treatment with fulvestrant
* Prior treatment with greater than (\>) 1 cytotoxic chemotherapy regimen or \>2 endocrine therapies for advanced or metastatic disease
18 Years
FEMALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Korea University Guro Hospital
Seoul, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Hospital Clinic
Barcelona, Cantabria, Spain
Complejo Hospitalario Universitario A Coruña; Servicio de Endocrinologia
A Coruña, LA Coruña, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Lerida, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hosp. Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Royal Sussex County Hospital
Brighton, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Sarah Cannon Research Institute
London, , United Kingdom
Macclesfield District General Hospital
Macclesfield, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-000106-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO29689
Identifier Type: -
Identifier Source: org_study_id
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