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SHR-A1811 Combine With Pyrotinib for Locally Advanced/Metastatic HER2 Positive Breast Cancer

NCT07132242 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-08-20

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if SHR-A1811 combine with Pyrotinib is safe and tolerable for patients with HER2 positive breast cancer. It will also learn about the anti-tumor efficacy of this combination therapy. Participants will take SHR-A1811 and pyrotinib every three weeks, until disease progression or intolerable toxicity.

Conditions

  • Metastatic Breast Cancer With HER2 Positive

Interventions

DRUG

SHR-A1811 4.0mg/kg

SHR-A1811 4.0mg/kg, IV, Day 1, Q3W

DRUG

Pyrotinib 240mg

Pyrotinib 240mg, po, QD, from Day 8 to Day 21,Q3W

DRUG

SHR-A1811 4.8mg/kg

SHR-A1811 4.8mg/kg, IV, D1, Q3W

DRUG

Pyrotinib 320mg

Pyrotinib 320mg, po, QD, from Day 8 to Day 21, Q3W

Sponsors & Collaborators

  • Yunnan Cancer Hospital

    collaborator OTHER

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2028-08-30
Completion
2028-12-31

More Related Trials

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 NCT07132242 on ClinicalTrials.gov