Pyrotinib for HER2-Positive Advanced Breast Cancer Previously Treated With Trastuzumab and Pertuzumab

September 3, 2026 updated by: Beijing 302 Hospital

Retrospective Analysis of Pyrotinib in the Treatment of HER2-Positive Advanced Breast Cancer Previously Treated With Trastuzumab and Pertuzumab

In China, pyrotinib is used for patients with HER2-positive advanced breast cancer who have progressed on trastuzumab. As anti-HER2 antibody therapy has advanced from trastuzumab monotherapy to trastuzumab-pertuzumab dual-target treatment, few clinical studies have investigated pyrotinib's efficacy among patients pre-treated with this dual-antibody regimen. This is a retrospective observational cohort study, which aims to assess the efficacy and safety of pyrotinib in this patient cohort.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100071
        • The Fifth Medical Center of the PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with HER2-positive advanced breast cancer who had previously been treated with either trastuzumab or pertuzumab, and who subsequently received pyrotinib-based therapy

Description

Inclusion Criteria:

  • 1. Diagnosis of unresectable locally advanced or metastatic breast cancer 2. Confirmed HER2-positive status, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with positive in situ hybridization (ISH) results 3. Prior systemic treatment of trastuzumab and pertuzumab 4. Adequate baseline cardiac, bone marrow, renal, hepatic, and blood coagulation functions 5. Life expectancy > 3 months 6. ECOG ≤3

Exclusion Criteria:

  • 1. Incomplete clinical case data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pyrotinib
Pyrotinib-treated patients with prior trastuzumab and pertuzumab exposure
Drug: Pyrotinib 400mg
Pyrotinib (400 mg daily)-based treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival(PFS)
Time Frame: 4 years
PFS was defined as the time from the start of treatment to either the first documented disease progression or death from any cause
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 1year
ORR was defined as the proportion of patients with a complete response or a partial response
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Investigators

  • Study Director: Tao Wang, Beijing 302 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PYROTINIB-HER2 POSITIVE BREAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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