Clinical trial · Interventional
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GB491 combined with Letrozole | Drug | — | UNRESOLVED |
| Placebo combined with Letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GB491 combined with Letrozole
- interventionNames
- Drug: GB491 combined with Letrozole
- type
- PLACEBO_COMPARATOR
- label
- Placebo combined with Letrozole
- interventionNames
- Drug: Placebo combined with Letrozole
Primary outcomes (1)
- measure
- Investigator-assessed PFS based on RECIST v1.1
- timeFrame
- Approximately 60 months
- description
- To evaluate progression-free survival (PFS) of GB491 plus Letrozole versus placebo plus Letrozole in HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy (as assessed by the investigator).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available