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

NCT02569801 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: GO296892015-000106-19
• Study Type: interventional
• Target: 71
• Locations: 6 countries
• Sites: 44

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• Overall Survival (OS)

  From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Fulvestrant

ACTIVE COMPARATOR

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.

Drug: Fulvestrant

GDC-0810

EXPERIMENTAL

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.

Drug: GDC-0810

Interventions

Fulvestrant DRUG

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.

Fulvestrant

GDC-0810 DRUG

GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.

Also known as: RO7056118

GDC-0810

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (44)

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Florida Cancer Specialists-Broadway, Fort Myers

Fort Myers, Florida, 33908, United States

Location

Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

St. Petersburg, Florida, 33705, United States

Location

Oncology Hematology Care Inc

Cincinnati, Ohio, 45242, United States

Location

Tennessee Oncology PLLC

Franklin, Tennessee, 37067, United States

Location

The Center for Cancer and Blood Disorders - Fort Worth

Fort Worth, Texas, 76104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Port Macquarie Base Hospital

Port Macquarie, New South Wales, 2444, Australia

Location

Adelaide Cancer Centre

Kurralta Park, South Australia, 5037, Australia

Location

Royal Hobart Hospital; Medical Oncology

Hobart, Tasmania, 7000, Australia

Location

Footscray Hospital

Footscray, Victoria, 3011, Australia

Location

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

Location

Epworth HealthCare; Clinical Trials Centre

Richmond, Victoria, 3121, Australia

Location

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Praxisklinik für Hämatologie und Onkologie Dres. Köppler/Heymans/Weide/Thomalla

Koblenz, 56068, Germany

Location

HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe

Krefeld, 47805, Germany

Location

Rotkreuzklinikum München; Frauenklinik

München, 80637, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Marien Hospital Witten Gemeinnützige GmbH

Witten, 58452, Germany

Location

Kyungpook National University Medical Center

Daegu, 41404, South Korea

Location

National Cancer Center

Goyang-si, 10408, South Korea

Location

Samsung Medical Center

Seoul, (0)6351, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Ulsan University Hosiptal

Ulsan, 44033, South Korea

Location

Hospital Clinic

Barcelona, Cantabria, 08036, Spain

Location

Complejo Hospitalario Universitario A Coruña; Servicio de Endocrinologia

A Coruña, LA Coruña, 15006, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, Lerida, 25198, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

University College Hospital

London, N7 9NH, United Kingdom

Location

Sarah Cannon Research Institute

London, W1G 6AD, United Kingdom

Location

Macclesfield District General Hospital

Macclesfield, SK10 3BL, United Kingdom

Location

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; 3-(4-(2-(2-chloro-4-fluorophenyl)-1-(1H-indazol-5-yl)but-1-en-1-yl)phenyl)acrylic acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 7, 2015
• Study Start: December 4, 2015
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: April 23, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-04

Locations

ES (10); AU (7); KR (6); GB (7); US (7); DE (7)