Status:
NOT_YET_RECRUITING
Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Triple-Negative Breast Cancer (TNBC)
Neoadjuvant Therapy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06910072
Start Date
April 2 2025
End Date
October 1 2028
Last Update
April 4 2025
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021