GB491 with Letrozole for Advanced Breast Cancer

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

Recruiting Phase 3 Interventional Study
Breast Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Genor Biopharma Co., Ltd. · Industry
Who this trial is looking for

This trial is looking for patients with advanced breast cancer that is hormone receptor-positive and HER2-negative. Participants will receive a treatment combining GB491 and Letrozole or a placebo with Letrozole.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 75 years old.
  • I have been diagnosed with hormone receptor-positive breast cancer.
  • I have not had previous treatment for locally advanced or metastatic breast cancer.
  • I have good organ and marrow function.
  • I agree to participate by signing an informed consent.

You may not be able to join if

  • I have taken other CDK4/6 inhibitors.
  • I am allergic to GB491 or Letrozole.
  • I have been diagnosed with HER2 positive breast cancer.
  • I have uncontrolled brain metastases.
  • I had major surgery or treatment in the last 4 weeks.
  • I have previously received chemotherapy for recurrent or metastatic breast cancer.
  • I have significant heart or blood vessel issues.
  • I have a history of HIV infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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

Trial Locations
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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; * Eas…
Contacts

Yankun Fu, Master

021-60751991

yankun.fu@genorbio.com

CONTACT