RecruitingPhase 3NCT06954961

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


Sponsor

InventisBio Co., Ltd

Enrollment

640 participants

Start Date

Sep 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called D-0502 in women with estrogen receptor-positive (ER+), HER2-negative breast cancer that has spread or cannot be removed by surgery. D-0502 is a type of selective estrogen receptor degrader (SERD) — it works by blocking and breaking down the estrogen receptor that fuels the cancer's growth. **You may be eligible if...** - You have ER-positive, HER2-negative breast cancer that has come back or spread - Your cancer progressed during or after hormone therapy (either adjuvant or after 1–2 lines of systemic treatment) - You have at least one measurable tumor on imaging, or bone lesions that can be evaluated - Your estimated survival is at least 12 weeks **You may NOT be eligible if...** - You have unstable or growing brain metastases (brain spread) - You have already received more than 2 prior chemotherapy regimens for metastatic disease - Your doctor considers you unsuitable for hormone therapy due to serious fluid buildup around the lungs, heart, or abdomen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGD-0502

* Dosage form: Tablet * Administration route: Oral, once a day

DRUGFulvestrant

* Dosage form: Injection * Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose


Locations(2)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

View Full Details on ClinicalTrials.gov

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NCT06954961


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