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A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer

NCT06057610 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 868

Last updated 2026-03-11

No results posted yet for this study

Summary

To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer

Conditions

  • HER2-PositiveRecurrent or Metastatic Breast Cancer

Interventions

DRUG

SHR-A1811 Injection

SHR-A1811 Injection

DRUG

SHR-A1811 Injection ； Pertuzumab Injection

SHR-A1811 Injection ； Pertuzumab Injection

DRUG

Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection

Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2027-10-31
Completion
2032-10-31

Countries

  • China

Study Locations

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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 NCT06057610 on ClinicalTrials.gov