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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is researching a combination of treatments to see how effective and safe they are for women with triple-negative breast cancer, a type of breast cancer that doesn't respond to some common hormones. The study will use a combination of paclitaxel polymeric micelles, carboplatin, iparomilimab, and tuvonralimab as neoadjuvant therapy, which means these treatments will be given before surgery to shrink the tumor. The main goal is to find out how many patients achieve a complete pathologic response (pCR), which means there is no detectable cancer in the tissue after treatment. The trial plans to enroll 32 women aged between 18 and 75.

To be eligible for this study, participants must have triple-negative breast cancer with a tumor larger than 2 cm and be in stages II or III. They should also be in generally good health with an expected survival of at least six months. It's important to note that women who are pregnant or breastfeeding cannot participate. While the trial is not yet recruiting, it aims to provide insights into new treatment options for this challenging cancer type. Participants can expect close monitoring and support throughout the study.

Gender

FEMALE

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