Evaluating D-0502 for treating advanced 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

This study is testing a new drug called D-0502 to see if it works better than the standard treatment for people with advanced breast cancer that is ER-positive and HER2-negative.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 640 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: InventisBio Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06954961 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, parallel-controlled, open-label study designed to assess the efficacy and safety of D-0502 in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. Participants will receive D-0502, while a control group will be treated with fulvestrant. The study aims to determine how well D-0502 works compared to the standard treatment in this patient population. It involves multiple centers and requires measurable lesions for eligibility.

Who should consider this trial

Good fit: Ideal candidates are individuals with ER-positive, HER2-negative locally advanced or metastatic breast cancer who have experienced disease recurrence or progression after prior endocrine therapy.

Not a fit: Patients with unstable or symptomatic central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer who have limited treatment choices.

How similar studies have performed: Other studies have explored treatments for ER-positive, HER2-negative breast cancer, but the specific approach with D-0502 is novel.

Eligibility criteria

Inclusion Criteria:

* Subjects pathologically confirmed with ER-positive, HER2-negative breast cancer;
* Subjects with locally advanced (unresectable) or metastatic breast cancer who have disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy;
* Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria; in the absence of measurable lesions, subjects with evaluable bone lesions \[osteolytic or mixed (osteolytic + osteogenic) bone lesions\] are also acceptable. Lesions that have been previously treated with radiotherapy or other local therapy can be regarded as measurable lesions only if there is disease progression as confirmed by imaging examination;
* Expected survival time ≥ 12 weeks;

Exclusion Criteria:

* Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases. Subjects with a history of brain metastases who are clinically stable and have no CNS disease progression confirmed by brain MRI or CT (if MRI is not appropriate) can be enrolled (MRI or CT examination must be conducted at least 4 weeks after the last brain radiotherapy);
* Subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy;
* Subjects are unsuitable for endocrine therapy judged by the investigator, including uncontrolled pleural effusion, ascites or pericardial effusion;
* Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
* Prior treatment with a selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA), such as fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn -c5, LX-039, HS234, etc.;
* Pregnant or lactating females;

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)

Study contacts

• Principal investigator: Binghe Xu, MD — Cancer Hospital
• Study coordinator: Yuting Li

Conditions Breast Cancer