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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-02

Study Completion Date

2028-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Triple-Negative Breast Cancer (TNBC) Neoadjuvant Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab

Intervention Type 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.

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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PENG YUAN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Xue Wang

Role: CONTACT

86-010-87787242

Facility Contacts

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Xue Wang

Role: primary

86-010-87787242

Other Identifiers

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NCC5182

Identifier Type: -

Identifier Source: org_study_id

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