A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
- Registration Number
- NCT02569801
- Lead Sponsor
- Genentech, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 71
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fulvestrant 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. GDC-0810 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
PFS According to RECIST v1.1 in Participants With Estrogen Receptor (ESR)1 Mutations From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST v1.1 or death on study from any cause.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1 From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) Objective Response was defined as the percentage of participants who attained CR or PR. CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Overall Survival (OS) From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months) OS is defined as the time from randomization to death from any cause.
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months) Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1 From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months) GDC-0810 Plasma Concentrations by Visit Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days Concentration of GDC-0810 measured in plasma after a single dose (Cycle 1 Day 1) and at steady state (Cycle 3 Day 1)
Duration of Response (DOR) Assessed Using RECIST v1.1 From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months) DOR was defined as the time from first observation of an objective response until first observation of disease progression as assessed by the investigator according to RECIST v1.1 or death from any cause.
Trial Locations
- Locations (44)
Florida Cancer Specialists-Broadway, Fort Myers
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
🇺🇸Saint Petersburg, Florida, United States
The Center for Cancer and Blood Disorders - Fort Worth
🇺🇸Fort Worth, 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
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
Universitätsklinikum Tübingen
🇩🇪Tuebingen, Germany
HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe
🇩🇪Krefeld, Germany
Rotkreuzklinikum München; Frauenklinik
🇩🇪Muenchen, Germany
Kyungpook National University Medical Center
🇰🇷Daegu, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Marien Hospital Witten Gemeinnützige GmbH
🇩🇪Witten, Germany
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hosiptal
🇰🇷Ulsan, Korea, Republic of
Hospital Clinic
🇪🇸Barcelona, Cantabria, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Lerida, Spain
Complejo Hospitalario Universitario A Coruña; Servicio de Endocrinologia
🇪🇸A Coruña, LA Coruña, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hosp. Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Sarah Cannon Research Institute
🇬🇧London, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
University College Hospital
🇬🇧London, United Kingdom
Tennessee Oncology PLLC
🇺🇸Franklin, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Peninsula and South Eastern Haematology and Oncology Group
🇦🇺Frankston, Victoria, Australia
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Footscray Hospital
🇦🇺Footscray, Victoria, Australia
Epworth HealthCare; Clinical Trials Centre
🇦🇺Richmond, Victoria, Australia
Oncology Hematology Care Inc
🇺🇸Cincinnati, Ohio, United States
St Bartholomew's Hospital
🇬🇧London, United Kingdom