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A Study Evaluating the Efficacy and Safety of De Trastuzumab (T-DXd) in Combination with Immunotherapy for the Neoadjuvant Treatment of HR-positive HER2 Low-expressing Chinese Patients with Early-stage Breast Cancer

NCT06733233 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-12-13

No results posted yet for this study

Summary

This is a prospective, open-label, multicenter, single-arm clinical study designed to compare the efficacy and safety of neoadjuvant treatment with T-DXd in combination with an immune checkpoint inhibitor in patients with primary intermediate- to high-risk HR-positive, HER2-overexpressing early-stage breast cancer.

Conditions

  • Breast Cancer, Estrogen Receptor-Positive
  • HER2 Low Breast Cancer

Interventions

DRUG

T-DXd combined with immune checkpoint inhibitor

Subjects who are eligible for the study and have signed informed consent will receive T-DXd in combination with an immune checkpoint inhibitor. The specific dosing regimen is as follows: T-DXd (5.4 mg/kg i.v. q3w) every 3 weeks for a total of 8 courses. Teraplizumab (240 mg/kg i.v. q3w), 1 course every 3 weeks for a total of 8 courses.

Sponsors & Collaborators

  • Guangzhou Women and Children's Medical Center

    lead OTHER

Principal Investigators

  • Li Jie director, Doctor · Women and Children's Medical Center of Guangzhou Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-01-01
Completion
2029-01-01

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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 NCT06733233 on ClinicalTrials.gov