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Recruiting NCT05851014

A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Phase III Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GB491 combined with Letrozole, Placebo combined with Letrozole.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting

Overview

The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy

Interventions

  • Drug GB491 combined with Letrozole
    Patients were randomized to receive GB491 150 mg orally twice daily, depending on their assignment. Letrozole 2.5 mg orally once a day from the first day of cycle 1 (one cycle every 28 days)
  • Drug Placebo combined with Letrozole
    Patients were randomized to receive placebo orally twice daily, depending on their assignment. Letrozole 2.5 mg orally once a day from the first day of cycle 1 (one cycle every 28 days)

Primary outcome measures

  • Investigator-assessed PFS based on RECIST v1.1 [Time frame: Approximately 60 months]
Secondary outcome measures (7)
  • BICR-assessed PFS based on RECIST v1.1. [Time frame: Approximately 60 months]
  • OS [Time frame: Approximately 60 months]
  • ORR [Time frame: Approximately 60 months]
  • DOR [Time frame: Approximately 60 months]
  • DCR [Time frame: Approximately 60 months]
  • CBR [Time frame: Approximately 60 months]
  • Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0 [Time frame: Approximately 60 months]

Eligibility criteria

Inclusion criteria

  • 1\. Age: 18-75 years old;
  • Have a pathologically-confirmed diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer;
  • No previous systematic antitumor therapy for locally advanced or metastatic breast cancer;
  • Eastern Cooperative Oncology Group \[ECOG\] 0-1;
  • Have adequate organ and marrow function;
  • Agree to sign the informed consent;

Exclusion criteria

  • Systematic treatment with any other CDK4/6 inhibitor；
  • Subjects with known allergy to GB491 or any component of Letrozole；
  • Confirmed diagnosis of HER2 positive disease;
  • Known uncontrolled, or symptomatic central nervous system metastases;
  • Had major surgery (or is expected to require major surgery during the study period), chemotherapy, radiation, any investigational drug, or other antitumor therapy within 4 weeks prior to randomization;
  • Have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer;
  • Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure, or ventricular arrhythmia which need medical intervention；
  • Known history of HIV infection or HIV seropositivity (including HIV antibody positive at the time of screening)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 52 centers
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu
  • The First Hospital of Anhui Medical University — Hefei
  • Anhui Cancer Hospital — Hefei
  • The Second Hosptial of Anhui Medical University — Hefei
  • Betjing Tiantan Hosptial，Capital Medical University — Beijing
  • Chinese PLA General Hospial — Beijing
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing
  • Chongqing University Cancer Hospital — Chongqing
  • … and 44 more centers

Identifiers

NCT: NCT05851014 · GB491-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗