Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy for Triple-Negative Breast Cancer

Sponsor
Fudan University
Study ID
NCT06977542
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • TNBC, Triple Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    a PD-1/ VEGF Bispecific Antibody, 20mg/kg, every 2 weeks; Chemotherapy : paclitaxel and carboplatin, followed by epirubicin-cyclophosphamide

Study Details

This study is a multicenter, single-arm, investigator-initiated Phase II clinical trial. Eligible patients with treatment-naive early or locally advanced triple-negative breast cancer (TNBC), clinically staged as Stage II-III, will receive neoadjuvant therapy with ivonescimab in combination with chemotherapy prior to surgery. During the neoadjuvant phase, ivonescimab will be administered for a total of 12 doses. Patients who complete the neoadjuvant treatment and are deemed surgically eligible must undergo definitive surgical intervention. Following surgery and pathological evaluation by the local pathology department at each participating center, patients will continue to receive adjuvant therapy with ivonescimab for an additional 14 doses, in addition to any subsequent treatment recommended by the investigator according to standard clinical practice. The primary endpoint of this study is the pathological complete response rate (pCR). Participants will also be followed for secondary endpoints including event-free survival (EFS), disease-free survival (DFS), and distant disease-free survival (DDFS), with a minimum follow-up duration of 2 years post-surgery.

Key Dates

Start date
Jun 30, 2025
Status verified
May 2025
Primary completion
Jan 31, 2029
Completion
Jan 31, 2032

Study Design

Enrollment
53 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Ivonescimab Plus Chemotherapy

Primary Outcome Measure

pathological complete response rate (pCR) [ Time Frame: Up to approximately 24 weeks ]

Central Contacts

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