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 range18 Years – 70 Years

SexFEMALE

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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

What they're measuring

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).

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-03

View on ClinicalTrials.gov More Metastatic Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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).

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).