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

Phase 2

Not yet recruiting

• Conditions: TNBC; TNBC - Triple-Negative Breast Cancer; Early Stage Triple-Negative Breast Carcinoma
• Interventions: Drug: Ivonescimab; Drug: Carboplatin; Drug: Docetaxel

• Registration Number: NCT07017673
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Study Start: 2025-07
• Primary Completion: 2027-12
• Study Completion: 2032-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Carboplatin and Ivonescimab	Ivonescimab	Carboplatin AUC6 and docetaxel 75 mg/m2 every 3 weeks x 6 cycles plus ivonescimab 20 mg/kg iv every 3 weeks x 6 cycles. Each cycle is 21 days. Trial interventions may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons (after all safety assessments have been completed).
Carboplatin and Ivonescimab	Carboplatin	Carboplatin AUC6 and docetaxel 75 mg/m2 every 3 weeks x 6 cycles plus ivonescimab 20 mg/kg iv every 3 weeks x 6 cycles. Each cycle is 21 days. Trial interventions may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons (after all safety assessments have been completed).
Carboplatin and Ivonescimab	Docetaxel	Carboplatin AUC6 and docetaxel 75 mg/m2 every 3 weeks x 6 cycles plus ivonescimab 20 mg/kg iv every 3 weeks x 6 cycles. Each cycle is 21 days. Trial interventions may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons (after all safety assessments have been completed).

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR) rate	6 months (From cycle 1 day 1 till surgery)	Pathological complete response (pCR) will be defined as the absence of invasive disease in the breast and lymph nodes at the time of SOC curative-intent surgery. This will be assessed at time of surgery. Pathological responses will be evaluated using residual cancer burden (RCB) classifier defined by ASCO/CAP guideline.

Secondary Outcome Measures

Name	Time	Method
To determine the overall safety of ivonescimab in combination with carboplatin and docetaxel in patients with early-stage TNBC by CTCAE v5.0.	9 months (From Cycle 1 until 90 days post last dose of study treatment)	Frequency and severity of treatment-emergent adverse events, evaluated by CTCAE v5.0.
Event-free survival (EFS)	From cycle 1 day 1 till end of follow up (up to 5 years)	Event-free survival (EFS) measured from start of study treatment to the first occurrence of recurrent disease, or death due to breast cancer.
Overall survival (OS)	From cycle 1 day 1 till end of follow up (up to 5 years)	Overall survival (OS) measured from start of study treatment to death or last contact (censored)
Patient-reported outcomes (PRO)	9 months	Patient-reported outcomes (PRO) will be measured by changes in the PROMIS Fatigue 7a measured at start of study treatment and End of Treatment. The PROMIS 7a scoring system uses a standardized T-score with a mean of 50 and a standard deviation of 10, allowing for comparison of individuals to the general population. A higher T-score generally indicates a higher level of the specific trait being measured (e.g., fatigue, anxiety, depression).

Trial Locations

Locations (4)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center Beverly Hills; 🇺🇸 Los Angeles, California, United States

Huntington Cancer Center, an Affiliate of CS Cancer; 🇺🇸 Pasadena, California, United States

Hunt Cancer Institute, an Affiliate of CS Cancer; 🇺🇸 Torrance, California, United States