Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
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
The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci z nawrotowym lub rozsinanym rakiem piersi potrójnie negatywnym (TNBC)
- •Rak TNBC potwierdzony badaniem immunohistochemicznym: brak receptorów estrogenowych i progesteronowych, oraz ujemny HER2
- •Poprzednie leczenie: brak lub tylko pierwsza linia chemioterapii dla raka nawrotowego/rozsinanego
- •Wiek 18-75 lat w momencie podpisania zgody
- •Dobry stan ogólny (ECOG 0-1)
- •Spodziewana przeżywalność co najmniej 3 miesiące
- •Co najmniej jeden mierzalny guz
- •Prawidłowa funkcja nerek i wątroby
✗ Disqualifies
- •Wcześniejsze leczenie inhibitorami punktów kontrolnych (anty-PD-1, anty-PD-L1 lub anty-CTLA-4)
- •Przerzuty do mózgu lub opon mózgowych
- •Aktywna choroba autoimmunologiczna wymagająca leczenia w ciągu ostatnich 2 lat
- •Pierwotny niedobór immunologiczny
- •Ciąża lub karmienie piersią
- •Inne choroby lub anomalie mogące wpłynąć na wyniki badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Last updated (source)
- May 20, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Trial contact
Jie Xiong, PhD
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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