MedTrace Logo

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

NCT06954961 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-03-31

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • InventisBio Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Binghe Xu, MD · Cancer Hospital

  • Qingyuan Zhang, MD · Harbin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2026-11-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06954961 on ClinicalTrials.gov