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Not yet recruiting NCT06910072

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

Phase II / Phase III Interventional Triple-Negative Breast Cancer (TNBC) Neoadjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab.
Who it may be relevant to
Registry conditions: Triple-Negative Breast Cancer (TNBC), Neoadjuvant Therapy. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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

  • Primary endpoint [Time frame: After surgery（within 1 month）]
Secondary outcome measures (3)
  • Objective response rate (ORR) [Time frame: During neoadjuvant therapy before surgery（within 6 months）]
  • The rate of event-free Survival (EFS) [Time frame: 2-year]
  • The incidence of treatment-related adverse event [Time frame: 2-year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06910072 · NCC5182

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗