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NCT Number: NCT07371910

Fluorizoparib Plus Apatinib Versus Chemotherapy in HRD-positive, HER2-negative Advanced Breast Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms HRD-Positive/HER2-Negative Advanced Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy/ADC Regimen

Drug

This is the initial induction phase of the experimental arm. Participants will receive 6 cycles of a standard intravenous or oral chemotherapy regimen or an Antibody-Drug Conjugate (ADC), selected by the investigator from protocol-specified options (e.g., eribulin, vinorelbine, gemcitabine, capecitabine, sacituzumab govitecan, or trastuzumab deruxtecan). Administration follows the standard schedule of the chosen agent. The purpose is to achieve disease control before switching to long-term maintenance therapy.

Fluorizoparib

Drug

This oral PARP inhibitor is administered as part of the maintenance phase. Participants who complete the 6-cycle induction phase without disease progression switch to Fluorizoparib twice daily in continuous 21-day cycles, in combination with Apatinib, until disease progression or unacceptable toxicity.

apatinib

Drug

This oral anti-angiogenic TKI is administered as part of the maintenance phase. Participants who complete the 6-cycle induction phase without disease progression switch to Apatinib once daily in continuous 21-day cycles, in combination with Fluorizoparib, until disease progression or unacceptable toxicity.

Physician's Choice Chemotherapy/ADC Regimen

Drug

Participants receive continuous treatment with a standard chemotherapy regimen or an Antibody-Drug Conjugate (ADC) selected by the investigator from protocol-specified options (e.g., eribulin, vinorelbine, gemcitabine, capecitabine, sacituzumab govitecan, or trastuzumab deruxtecan). Treatment is administered intravenously or orally according to the standard schedule of the chosen agent and continues without a planned switch to the oral targeted combination therapy, until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Primary outcomes

  1. Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

    Time frame: 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)

    Time frame: From randomization until disease progression or death (assessed up to approximately 4 years).

    The time from randomization to the first documented disease progression according to RECIST 1.1 criteria, or death from any cause, whichever occurs first.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From randomization until first documented response or progression (assessed every 6-8 weeks during treatment, up to approximately 2 years)

  2. Overall Survival (OS)

    Time frame: From randomization until death from any cause (assessed up to approximately 7 years, which is the total study duration)

  3. Clinical Benefit Rate (CBR)

    Time frame: From randomization until progression or 24 weeks of stable disease (assessed up to approximately 2 years).

  4. Disease Control Rate (DCR)

    Time frame: From randomization until the end of treatment or progression (assessed up to approximately 2 years)

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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