Fluorizoparib Plus Apatinib Versus Chemotherapy in HRD-positive, HER2-negative Advanced Breast Ca… (NCT07371910) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Fluorizoparib Plus Apatinib Versus Chemotherapy in HRD-positive, HER2-negative Advanced Breast Cancer
China200 participantsStarted 2024-06-12
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: From randomization until disease progression or death (assessed up to approximately 4 years).
2
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: From randomization until disease progression or death (assessed up to approximately 4 years).
Trial details
NCT IDNCT07371910
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University