Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy
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
This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment. Secondary endpoints include invasive disease- free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), as well as safety and patient-reported outcomes. These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients. The study anticipates a total sample size of 375 patients, who will be randomly assigned to either the experimental group or the control group. The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab. The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo. This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Podpisana świadoma zgoda na uczestnictwo w badaniu
- •Kobieta w wieku co najmniej 18 lat
- •Potwierdzony zaawansowany rak piersi (odpowiednie stadium zaawansowania)
- •Rak piersi potrójnie negatywny potwierdzona badaniem próbki tkanki
- •Przeprowadzona chemioterapia przedoperacyjna i leczenie camrelizumabem
- •Brak całkowitej odpowiedzi na leczenie przed operacją
- •Całkowite usunięcie wszystkich widocznych zmian w piersi i węzłach chłonnych
- •Dobry stan ogólny (skala ECOG 0-1) i prawidłowe parametry serca, krwi i narządów
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- March 15, 2024
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Trial contact
Shicheng Su
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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