Clinical Trial: NCT05077449
A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Xuanzhu Biopharmaceutical Co., Ltd. |
| Information Provided By: | Xuanzhu Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2024-05-24 |
Study Overview
Brief Summary
This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.
Official Title
A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
Conditions
Advanced Breast Cancer
Intervention / Treatment
- Drug: XZP-3287+Fulvestrant
- Drug: Placebo + Fulvestrant
Other Study ID Numbers
- XZP-3287-3001
Start Date (Actual)
2021-11-16
Primary Completion Date (Actual)
2024-02-22
Study Completion Date (Estimated)
2029-11
Enrollment (Estimated)
300
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Xuanzhu Biopharmaceutical Co., Ltd. |
| Information Provided By: | Xuanzhu Biopharmaceutical Co., Ltd. |
| Last Update Posted: | 2024-05-24 |
Study Overview
Brief Summary
This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.
Official Title
A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer
Conditions
Advanced Breast Cancer
Intervention / Treatment
- Drug: XZP-3287+Fulvestrant
- Drug: Placebo + Fulvestrant
Other Study ID Numbers
- XZP-3287-3001
Start Date (Actual)
2021-11-16
Primary Completion Date (Actual)
2024-02-22
Study Completion Date (Estimated)
2029-11
Enrollment (Estimated)
300
Study Type
Interventional
Phase
Phase 3