Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer
NCT ID: NCT06910072
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
32 participants
INTERVENTIONAL
2025-04-02
2028-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemotherapy combined with immunotherapy
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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PENG YUAN
Professor
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC5182
Identifier Type: -
Identifier Source: org_study_id
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