A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Breast cancer is the most common malignancy in women; approximately 5-10% are hereditary, with 14% of triple-negative breast cancers (TNBC) harboring BRCA mutations. BRCA1/2 are essential for homologous recombination repair of DNA double-strand breaks, whereas PARP mediates base-excision repair of single-strand breaks. PARP inhibitors (PARPi) exploit synthetic lethality to selectively eliminate BRCA-deficient tumor cells. Olaparib and talazoparib have demonstrated superior PFS and ORR versus chemotherapy in BRCA-mutated, HER2-negative advanced breast cancer, leading to FDA approval. In ovarian cancer, PARPi maintenance improves overall survival, with consistent benefits observed in Asian populations. The domestically developed PARPi fluzoparib, engineered with a trifluoromethyl moiety for enhanced stability and tissue penetration, showed in the phase III FABULOUS trial a median PFS of 6.7 vs 3.0 months and an ORR of 43.6% vs 23.3% compared with chemotherapy in gBRCA-mutated, HER2-negative breast cancer, with manageable safety. Data remain limited in Chinese patients and those with BRCA wild-type disease. This study aims to evaluate the efficacy and safety of fluzoparib maintenance monotherapy in advanced TNBC patients-either BRCA1/2-mutated or wild-type-who have derived clinical benefit from prior platinum-based therapy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat w momencie wyrażenia zgody na udział w badaniu
- •Potwierdzony histologicznie rak piersi potrójnie negatywny (bez receptorów hormonalnych i HER2)
- •Ogólny stan zdrowia pozwalający na aktywność życiową (0-1 w skali ECOG)
- •Wcześniejsze leczenie co najmniej dwoma schematami, w tym chemioterapią platynową, z odpowiedzią lub stabilizacją choroby
- •Wrażliwość na platynę - brak wzrostu choroby przez co najmniej 6 miesięcy po leczeniu platynią lub po jej zakończeniu
- •Oczekiwana długość życia co najmniej 3 miesiące
- •Widoczne zmiany nowotworowe w badaniach obrazowych (CT/MRI)
- •Wystarczająca funkcja narządów (wątroba, nerki, krew) w badaniach laboratoryjnych
✗ Disqualifies
- •Uczulenie na fluzoparib lub jego składniki
- •Wcześniejsze leczenie innym inhibitorem PARP
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- August 21, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Trial contact
Weipeng Zhao
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/22/2026.
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