A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy

Breast Cancer Clinical Trial

— HydranGea  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02569801
• Other study ID #: GO29689
• Secondary ID: 2015-000106-19
• Status: Terminated
• Phase: Phase 2
• Start date: December 4, 2015
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2021
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	St Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Footscray Hospital	Footscray	Victoria
Australia	Peninsula and South Eastern Haematology and Oncology Group	Frankston	Victoria
Australia	Royal Hobart Hospital; Medical Oncology	Hobart	Tasmania
Australia	Adelaide Cancer Centre	Kurralta Park	South Australia
Australia	Port Macquarie Base Hospital	Port Macquarie	New South Wales
Australia	Epworth HealthCare; Clinical Trials Centre	Richmond	Victoria
Germany	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	Muenchen
Germany	Universitätsklinikum Tübingen	Tuebingen
Germany	Marien Hospital Witten Gemeinnützige GmbH	Witten
Korea, Republic of	Kyungpook National University Medical Center	Daegu
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Ulsan University Hosiptal	Ulsan
Spain	Complejo Hospitalario Universitario A Coruña; Servicio de Endocrinologia	A Coruña	LA Coruña
Spain	Hospital Clinic	Barcelona	Cantabria
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari Arnau de Vilanova	Lleida	Lerida
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Clinico Universitario de Valencia	Valencia
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Sarah Cannon Research Institute	London
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	University College Hospital	London
United Kingdom	Macclesfield District General Hospital	Macclesfield
United Kingdom	Nottingham City Hospital	Nottingham
United States	Oncology Hematology Care Inc	Cincinnati	Ohio
United States	Florida Cancer Specialists-Broadway, Fort Myers	Fort Myers	Florida
United States	The Center for Cancer and Blood Disorders - Fort Worth	Fort Worth	Texas
United States	Tennessee Oncology PLLC	Franklin	Tennessee
United States	MD Anderson Cancer Center	Houston	Texas
United States	Yale Cancer Center	New Haven	Connecticut
United States	Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Korea, Republic of,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population	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.	From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Primary	PFS According to RECIST v1.1 in Participants With Estrogen Receptor (ESR)1 Mutations	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.	From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death from any cause.	From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary	Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1	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.	From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary	Duration of Response (DOR) Assessed Using RECIST v1.1	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.	From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary	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)
Secondary	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)
Secondary	GDC-0810 Plasma Concentrations by Visit	Concentration of GDC-0810 measured in plasma after a single dose (Cycle 1 Day 1) and at steady state (Cycle 3 Day 1)	Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days