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Evaluation of Neoadjuvant Therapy With Trastuzumab, Pertuzumab, Docetaxel, and QL1706 in Early or Locally Advanced HER2+ Breast Cancer

NCT07246317 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-11-28

No results posted yet for this study

Summary

This study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer.

Conditions

Interventions

DRUG

QL1706 injection

On Day 1 of each cycle at a dose of 5 mg/kg, IV infusion

DRUG

Trastuzumab (or biosimilar)

On Day 1 of each cycle; 8 mg/kg IV loading dose followed by 6 mg/kg IV every 3 weeks

DRUG

Pertuzumab (or biosimilar)

On Day 1 of each cycle; 840 mg IV loading dose followed by 420 mg IV every 3 weeks

DRUG

Docetaxel

On Day 1 of each cycle at a dose of 75 mg/m², IV infusion

DRUG

Carboplatin

On Day 1 of each cycle at a dose of AUC = 4, IV infusion

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2027-12-31
Completion
2032-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT07246317 on ClinicalTrials.gov