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NCT Number: NCT06910072

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

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.

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Key information

Conditions

Triple-Negative Breast Cancer (TNBC) Breast Diseases Breast Neoplasms Neoadjuvant Therapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Primary endpoint

    Time frame: After surgery（within 1 month）

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

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: During neoadjuvant therapy before surgery（within 6 months）

  2. The rate of event-free Survival (EFS)

    Time frame: 2-year

  3. The incidence of treatment-related adverse event

    Time frame: 2-year

Study contacts

Contact information is provided by the study sponsor or research team.

Xue Wang

CONTACT

[email protected]

86-010-87787242

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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