OncoMatch/Clinical Trials/NCT07017673
Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer
Is NCT07017673 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ivonescimab and Carboplatin for tnbc.
Treatment: Ivonescimab · Carboplatin · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression ≤10% (≤10%)
ER≤10%
Required: PR (PGR) expression ≤10% (≤10%)
PR≤10%
Required: HER2 (ERBB2) negative (by IHC or FISH) (negative)
HER2 negative (by IHC or FISH)
Disease stage
Required: Stage ≥T1CN0, ANY T, N1-2
Clinically ≥T1cN0, or any T, N1-2
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: radiation therapy with curative intent for the current breast cancer also excluded
Prior systemic therapy or radiation therapy with curative intent for the current breast cancer
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)
Cannot have received: definitive ipsilateral breast surgery
A previous definitive ipsilateral breast surgery for the current breast cancer
Lab requirements
Blood counts
anc ≥ 1,500/mm3; platelets ≥ 100,000/mm3; hemoglobin ≥ 9.0 g/dl
Kidney function
creatinine clearance ≥ 30 ml/min
Liver function
total serum bilirubin ≤ 1.5 x uln or direct bilirubin ≤uln for participants with total bilirubin levels >1.5 x uln; ast < 3 x uln; alt < 3 x uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Medical Center · Los Angeles, California
- Cedars-Sinai Medical Center Beverly Hills · Los Angeles, California
- Huntington Cancer Center, an Affiliate of CS Cancer · Pasadena, California
- Hunt Cancer Institute, an Affiliate of CS Cancer · Torrance, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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