RecruitingPhase 3NCT06255392

Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer


Sponsor

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

Enrollment

200 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study develops a new therapeutic approach for HER2-negative advanced breast cancer patients without precise treatment targets. The trial aims at extending the combination target therapy involving PARP inhibitors and anti-angiogenesis from only BRCA mutation carriers to all patients with homologous recombination repair defects (HRD-positive). The phase III randomized clinical study will investigate the effectiveness of the combination therapy of PARP inhibitor "fludzoparib" and anti-angiogenic "apatinib" in treating HRD-positive/HER2-negative advanced breast cancers.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a maintenance treatment strategy for women with HER2-negative, HRD-positive metastatic breast cancer who have already benefited from chemotherapy. HRD-positive means there is a DNA repair defect in the tumor that may respond to specific targeted drugs. The study evaluates whether continuing a targeted maintenance therapy after an initial chemo response extends how long the disease stays controlled. **You may be eligible if...** - You are a woman aged 18–70 with HER2-negative, HRD-positive metastatic breast cancer - Your tumor has a BRCA mutation or a high HRD score (42+) - You achieved a clinical benefit (tumor shrinkage or stabilization) after 6–8 cycles of chemo - You have received no more than two prior lines of chemotherapy for metastatic disease **You may NOT be eligible if...** - Your tumor is HER2-positive or HRD-negative - You have not responded to initial chemotherapy - You have received more than two prior lines of chemotherapy - Your general health or organ function is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFluzoparib

Fluzoparib capsules appropriate dose oral, each treatment cycle defined as 3 weeks (21 days).

DRUGApatinib Mesylate

Apatinib Mesylate oral; each treatment cycle defined as 3 weeks (21 days).

DRUGCapecitabine tablets

Capecitabine tablets, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).

DRUGVinorelbine Tartrate Oral

For the first three courses: reasonable dosage with reference to guidelines. After 3 courses of medication, it is recommended to increase the dose of vinorelbine tartrate once a week. Each treatment cycle defined as 3 weeks (21 days).

DRUGEribulin mesylate injection

Eribulin, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).

DRUGGemcitabine Hydrochloride

Gemcitabine, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).

DRUGPaclitaxel-albumin

Paclitaxel-albumin, reasonable dosage with reference to guidelines, each treatment cycle defined as 3 weeks (21 days).


Locations(1)

Sun Yat Sen Memorial Hospital,Sun Yat sen University

Guangzhou, Guangdong, China

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NCT06255392