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

NCT06910072 | Not Yet Recruiting Phase 2

• 1 other identifier: NCC5182
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple-Negative Breast Cancer (TNBC); Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  Pathological complete response (pCR) rates in patients with triple-negative breast cancer

  After surgery（within 1 month）

Secondary Outcomes (3)

• Objective response rate (ORR)

  During neoadjuvant therapy before surgery（within 6 months）

• The rate of event-free Survival (EFS)

  2-year

• The incidence of treatment-related adverse event

  2-year

Study Arms (1)

Chemotherapy combined with immunotherapy

EXPERIMENTAL

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.

Drug: paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab

Interventions

paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab DRUG

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.

Chemotherapy combined with immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Central Study Contacts

Xue Wang

CONTACT

86-010-87787242; wxyxyuki@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: April 4, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)