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

Phase 2

Not yet recruiting

• Conditions: Triple-Negative Breast Cancer (TNBC); Neoadjuvant Therapy
• Interventions: Drug: paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab

• Registration Number: NCT06910072
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study Start: 2025-04-02
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy combined with immunotherapy	paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab	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.

Primary Outcome Measures

Name	Time	Method
Primary endpoint	After surgery（within 1 month）	Pathological complete response (pCR) rates in patients with triple-negative breast cancer

Secondary Outcome Measures

Name	Time	Method
The rate of event-free Survival (EFS)	2-year
Objective response rate (ORR)	During neoadjuvant therapy before surgery（within 6 months）
The incidence of treatment-related adverse event	2-year

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China