Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Neoadjuvant Therapy; Triple-Negative Breast Cancer (TNBC)

Treatments: Drug: paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06910072

NCC5182

Details and patient eligibility

About

This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. The main endpoint of the study is pCR, 32 patients are scheduled to be enrolled.

Enrollment: 32 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Triple-negative breast cancer
• The diameter of the primary tumor must be greater than 2cm, and the clinical stage should be II-III
• There is sufficient primary organ function
• The ECOG (PS) score is 0 or 1
• Expected survival ≥ 6 months
• The serum pregnancy test was negative. Use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug, and do not breastfeed

Exclusion criteria

• Bilateral breast cancer
• There is a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
• A history of invasive or metastatic breast cancer
• Any malignancy diagnosed within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma
• There is an immune deficiency disease
• The presence of any autoimmune disease that still requires treatment or a history of prior autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Chemotherapy combined with immunotherapy

Experimental group

Description:

paclitaxel polymeric micelles 300mg/m2, d1 carboplatin AUC=5, d1 iparomilimab and tuvonralimab 5mg/kg, d1 Every 3 weeks (Q3W) is a cycle, a total of 6 cycles.

Treatment:

Drug: paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab