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Prospective Multicenter Single-arm Trial: AK112 + Nab-paclitaxel/Carboplatin Neoadjuvant for TNBC

NCT07103447 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-08-05

No results posted yet for this study

Summary

This prospective, multicenter, single-arm clinical study aims to evaluate the efficacy and safety of AK112 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant treatment in adult women with early or locally advanced triple-negative breast cancer (TNBC). The study seeks to address the pathological complete response (pCR) rate, objective response rate (ORR), breast conservation rate, and invasive disease-free survival (iDFS) following treatment with AK112 combined with albumin-bound paclitaxel and carboplatin in early or locally advanced TNBC.

Conditions

  • Breast Cancer - Female

Interventions

DRUG

AK112, Carboplatin, Paxlitaxel

The combination of AK112, a platinum-based chemotherapy agent, and Paxlitaxel is administered every three weeks as a neoadjuvant treatment for triple-negative breast cancer. After completing six cycles of this regimen, the participant undergoes surgical treatment.

Sponsors & Collaborators

  • Shuangyue Liu

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2027-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103447 on ClinicalTrials.gov