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

NCT07810634 | Active Not Recruiting

• 1 other identifier: PYROTINIB-HER2 POSITIVE BREAST
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival(PFS)

  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 Outcomes (1)

• Objective response rate (ORR)

  1year

Study Arms (1)

Pyrotinib

Pyrotinib-treated patients with prior trastuzumab and pertuzumab exposure

Drug: Pyrotinib 400mg

Interventions

Pyrotinib 400mg DRUG

Pyrotinib (400 mg daily)-based treatment

Pyrotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \. 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

You may not qualify if:

• \. Incomplete clinical case data

Sponsors & Collaborators

• Beijing 302 Hospital: lead

Study Sites (1)

The Fifth Medical Center of the PLA General Hospital

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tao Wang

  Beijing 302 Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

CN (1)