NCT07371910Active, not recruitingPhase 3
Fluorizoparib Plus Apatinib Versus Chemotherapy in HRD-positive, HER2-negative Advanced Breast Cancer
A Randomized, Open-label, Controlled, Multicenter Phase III Study of Fluorizoparib in Combination With Apatinib Versus Investigator's Choice Chemotherapy in Patients With HRD-positive, HER2-negative Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
This is a Phase III clinical trial for patients with a specific type of advanced breast cancer that is HER2-negative and has a biomarker called "Homologous Recombination Deficiency (HRD)-positive." The study aims to compare the effectiveness and safety of two treatment strategies: Experimental Group: Patients will first receive 6 cycles of standard chemotherapy or antibody-drug conjugate (ADC) therapy chosen by their doctor. After completing these 6 cycles, they will switch to a combination of two oral targeted drugs: Fluorizoparib and Apatinib, as long-term maintenance therapy. Control Group: Patients will continue to receive their doctor's choice of standard chemotherapy or ADC therapy without switching to the targeted drug combination. Patients will be randomly assigned (like flipping a coin) to one of the two groups.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 14 Jan 2026
- Start date
- 12 Jun 2024
- Primary completion date
- Mar 2031
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07371910
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- From 12 Jun 2024 to the primary completion date, Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- HR+/HER2- patients who have not received prior endocrine therapy for metastatic disease.
- Have not received any prior systemic therapy for metastatic breast cancer.
- Have received \>2 prior lines of chemotherapy or ADC therapy for metastatic disease.
- Known severe hypersensitivity to any component of the study drugs.
- Pregnant, lactating, or women of childbearing potential unwilling to use effective contraception.
- Uncontrolled or significant cardiovascular disease.
- Any other condition deemed inappropriate for the study by the investigato
Who the study is looking for
- Female patients aged 18-70 years.
- Histologically confirmed HER2-negative metastatic breast cancer.
- Documented HRD-positive status (defined as BRCA1/2 mutation and/or HRD positive).
- HR+/HER2- patients must have received prior endocrine therapy for metastatic disease.
- Have received no more than 2 prior lines of chemotherapy or ADC therapy for metastatic disease.
- At least one measurable lesion per RECIST 1.1.
- ECOG performance status 0-2 and life expectancy ≥3 months.
- Adequate organ function (bone marrow, liver, renal, cardiac).
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.