Trials / Active Not Recruiting
Active Not RecruitingNCT05257395
A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer
A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 397 (actual)
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XZP-3287+ Letrozole/Anastrozole | XZP-3287 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle |
| DRUG | Placebo + Letrozole/Anastrozole | Placebo 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle |
Timeline
- Start date
- 2022-03-14
- Primary completion
- 2025-12-05
- Completion
- 2030-09-05
- First posted
- 2022-02-25
- Last updated
- 2025-07-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05257395. Inclusion in this directory is not an endorsement.