PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC
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
In TNBC patients who have completed neoadjuvant immunotherapy and local treatment, a 9-cycle regimen of PD-1 inhibitor adjuvant immunotherapy is currently considered the standard approach. Based on the classification according to their BRCA mutation status, patients with BRCA mutations choose the PD-1 inhibitor + PARPi regimen, while patients without BRCA mutations opt for the PD-1 inhibitor + capecitabine regimen. Compared to monotherapy with PD-1 inhibitors, these combination regimens may offer improved efficacy and acceptable tolerability. This study is designed as a prospective, randomized, controlled, open-label, single-center phase III trial aimed at assessing the efficacy and safety of selecting PARPi or capecitabine in combination with PD-1 inhibitors based on germline BRCA1/2 mutations as adjuvant therapy in high-risk TNBC patients who have achieved non-pCR after completion of neoadjuvant immunotherapy in conjunction with chemotherapy and local treatment.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony na podstawie biopsji zaawansowany rak piersi.
- •Brak receptorów hormonalnych (receptory estrogenowe i progesteronowe są ujemne).
- •Brak nadmiaru białka HER2 (określone metodami laboratoryjnymi).
- •Zaawansowanie nowotworu w stadiums: T1c-T4 z węzłami chłonnymi N0-N2.
- •Wystarczająca funkcja wątroby i nerek (badania krwi spełniające określone normy).
- •Prawidłowa liczba krwinek białych i płytek krwi (w normie lub nieznacznie poniżej).
- •Prawidłowa funkcja serca (wymiotowanie lewej komory ≥55%).
- •Kobiety w wieku rozrodczym muszą być ujemne w teście ciąży i stosować antykoncepcję przez 6 miesięcy.
✗ Disqualifies
- •Znana alergia na składniki badanego leku.
- •Wcześniejsze leczenie raka lub napromienianie (z wyjątkiem wyleczonego raka szyjki macicy).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- November 4, 2024
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University
Guangzhou, China
Trial contact
Liulu Zhang, MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.