Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage 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
This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg/kg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg/m2 on Day 1 of each cycle for 6 cycles. Cycles will be 21 days for a total of 6 cycles. Curative intent surgery will be performed within 6 weeks (maximum 12 weeks) time frame upon completion of last dose of chemoimmunotherapy. The surgical pathology information will be used for assessment of pathological response, which serve as the primary endpoint of this study. Patients will undergo assessment at baseline, C1D1 of each cycle and end of treatment visit for collection of treatment-emergent adverse events, evaluated by CTCAE v5.0. Patient reported outcomes will be collected at cycles 1, 4, and 6, and at EOT. All study patients will be followed for at least 5 years for EFS and OS follow up. Research biopsies, peripheral blood and stool samples will be collected at the following time points: baseline, C4D1 (+/-14 days), and surgery (+/-14 days). Baseline and EOT breast MRI will be performed as standard of care for assessment of clinical response. Mid treatment breast ultrasound (C4D1 +/-14 days) will be repeated as standard of care to assess clinical response to treatment. Mid-treatment C4D1 tumor biopsy may be omitted if the primary tumor is no longer visible or the tumor deemed too small for biopsy by radiologist.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potrójnie negatywny nowotwór piersi we wczesnym stadium, wysokiego ryzyka (negatywny na receptory estrogenowe, progesteronowe i HER2)
- •Guz o rozmiarze co najmniej T1c lub każdy rozmiar z przerzutami do węzłów chłonnych N1-2
- •Zaplanowana chemioterapia przed operacją wraz z immunoterapią
- •Prawidłowe wyniki badań krwi: liczba białych krwinek ≥1500, płytki ≥100000, hemoglobina ≥9.0
- •Prawidłowa czynność wątroby i nerek
- •Kobiety mogą uczestniczyć tylko jeśli nie są w ciąży, nie karmią piersią i stosują antykoncepcję przez 120 dni po leczeniu
- •Podpisana świadoma zgoda uczestnika na udział w badaniu
✗ Disqualifies
- •Przerzuty nowotworu poza pierś
- •Uczestnictwo w innym badaniu klinicznym w ciągu ostatnich 4 tygodni
- •Historia zaburzeń krwawienia lub skrzepów krwi, w tym kaszel z krwią, krwawienia z nosa lub inne krwawienia w ciągu 4 tygodni
- •Stosowanie leków przeciw zwijaniu się krwi, które nie są stabilne przed rozpoczęciem badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (4)
Cedars-Sinai Medical Center
Los Angeles, United States
Cedars-Sinai Medical Center Beverly Hills
Los Angeles, United States
Huntington Cancer Center, an Affiliate of CS Cancer
Pasadena, United States
Hunt Cancer Institute, an Affiliate of CS Cancer
Torrance, United States
Trial contact
Clinical Trial Navigator
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.