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

Phase 2TerminatedNCT02569801

Genentech, Inc.71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (44)

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 25 months)

Secondary Outcomes

Overall Survival (OS)

OS is defined as the time from randomization to death from any cause.

Time frame: 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

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.

Time frame: 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

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.

Time frame: 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

Time frame: 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)

Time frame: From Day 1 to 28 days after last dose of study drug, assessed up to end of study (up to approximately 25 months)

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)

Time frame: Predose (within 30 minutes of GDC-0810 administration) and 3 hours postdose on Day 1 of Cycles 1 and 3; Cycle length=28 days