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

NCT05851014 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-05-09

No results posted yet for this study

Summary

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

Conditions

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)

Sponsors & Collaborators

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xichun Hu, Ph.D · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-14
Primary Completion
2026-01-30
Completion
2027-01-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851014 on ClinicalTrials.gov