Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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