NCT05851014 A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
| NCT ID | NCT05851014 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Genor Biopharma Co., Ltd. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2022-01-14 |
| Primary Completion | 2026-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 350 participants in total. It began in 2022-01-14 with a primary completion date of 2026-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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)
Contact & Investigator
Xichun Hu, Ph.D
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05851014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05851014 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 350 participants.
Is NCT05851014 currently recruiting?
Yes, NCT05851014 is actively recruiting participants. Contact the research team at yankun.fu@genorbio.com for enrollment information.
Where is the NCT05851014 trial being conducted?
This trial is being conducted at Bengbu, China, Hefei, China, Hefei, China, Hefei, China and 11 additional locations.
Who is sponsoring the NCT05851014 clinical trial?
NCT05851014 is sponsored by Genor Biopharma Co., Ltd.. The principal investigator is Xichun Hu, Ph.D at Fudan University. The trial plans to enroll 350 participants.
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