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

NCT05077449 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Xuanzhu Biopharmaceutical Co., Ltd.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	300
Start date	2021-11-16
Completion	2029-11

Conditions

• Advanced Breast Cancer

Interventions

• XZP-3287+Fulvestrant
• Placebo + Fulvestrant

Primary outcomes

• Investigator-assessed progression free survival (PFS) — Up to approximately 24 months
  An interim analysis will be performed in this study. The primary endpoint of the study is PFS. An interim analysis is scheduled upon the collection of 70%(approximately 125) PFS events, and the final PFS analysis will be conducted after 178 PFS events have been collected.

Countries

China