NCT06954961

A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer

A Randomized, Parallel-controlled, Open-label, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of D-0502 With Fulvestrant in Patients With Previously Treated ER-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 640 (estimated)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	D-0502	* Dosage form: Tablet * Administration route: Oral, once a day
DRUG	Fulvestrant	* Dosage form: Injection * Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose

Timeline

• Start date: 2022-09-15
• Primary completion: 2026-11-30
• Completion: 2028-12-31
• First posted: 2025-05-02
• Last updated: 2026-03-31

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study