Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria * Age ≥ 18 years of age * ECOG ≤ 1 * High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO/CAP guidelines * Clinically ≥T1cN0, or any T, N1-2 * Plan to receive neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery as standard-of-care treatment * Adequate organ function as defined in the following. Specimens must be collected within 14 days prior to the start of study treatment. * ANC ≥ 1,500/mm3 * Platelets ≥ 100,000/mm3 * Hemoglobin ≥ 9.0 g/dL. * 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 * Creatinine clearance ≥ 30 mL/min * INR or PT, aPTT \< 1.5 x ULN * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 14 days of start of study treatment. If the urine test is positive or cannot be confirmed as negativ…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Source