Actively Recruiting

Phase 3
Age: 18Years - 75Years
FEMALE
NCT06954961

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

Led by InventisBio Co., Ltd · Updated on 2026-03-31

640

Participants Needed

2

Research Sites

328 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with breast cancer confirmed as ER-positive and HER2-negative
  • Locally advanced or metastatic breast cancer with disease recurrence during or after adjuvant endocrine therapy, or progression after 1-2 lines of systemic endocrine therapy
  • At least one measurable lesion by CT or MRI based on RECIST V1.1 criteria, or evaluable bone lesions if no measurable lesions
  • Expected survival time of at least 12 weeks
Not Eligible

You will not qualify if you...

  • Unstable, symptomatic, or progressive central nervous system metastases
  • More than 2 prior systemic chemotherapy treatments for locally advanced or metastatic breast cancer
  • Unsuitable for endocrine therapy due to uncontrolled pleural effusion, ascites, or pericardial effusion
  • Serious cardiovascular, respiratory, or neurological diseases increasing risk of toxicity
  • Prior treatment with selective estrogen receptor degraders or covalent antagonists such as fulvestrant
  • Pregnant or breastfeeding females

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

2

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150081

Actively Recruiting

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Research Team

Y

Yuting Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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