Clinical trial NCT02569801: A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intent-to-Treat (ITT) Population
timeFrame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
measure: PFS According to RECIST v1.1 in Participants With Estrogen Receptor (ESR)1 Mutations
timeFrame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 25 months)
measure: Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]) According to RECIST v1.1
timeFrame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
measure: Duration of Response (DOR) Assessed Using RECIST v1.1
timeFrame: From objective response to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
measure: Percentage of Participants With Clinical Benefit (PR, CR, or Stable Disease, Lasting for At Least 24 Weeks) Assessed Using RECIST v1.1
timeFrame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months)
measure: GDC-0810 Plasma Concentrations by Visit
timeFrame: Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists-Broadway, Fort Myers
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
state: Florida
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc
state: Ohio
city: Franklin
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders - Fort Worth
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital; Medical Oncology
state: Tasmania
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Group
state: Victoria
city: Richmond
country: Australia
facility: Epworth HealthCare; Clinical Trials Centre
state: Victoria
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Koblenz
country: Germany
facility: Praxisklinik für Hämatologie und Onkologie Dres. Köppler/Heymans/Weide/Thomalla
city: Krefeld
country: Germany
facility: HELIOS Klinikum Krefeld; Klinik für Frauenheilkunde und Geburtshilfe
city: Muenchen
country: Germany
facility: Rotkreuzklinikum München; Frauenklinik
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Witten
country: Germany
facility: Marien Hospital Witten Gemeinnützige GmbH
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
city: Barcelona
country: Spain
facility: Hospital Clinic
state: Cantabria
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña; Servicio de Endocrinologia
state: LA Coruña
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
state: Lerida
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
city: Macclesfield
country: United Kingdom
facility: Macclesfield District General Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: