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

N/AActive Not RecruitingNCT07810634

Beijing 302 Hospital200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Breast Cancer

Interventions

Pyrotinib 400mgDRUG

Pyrotinib (400 mg daily)-based treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Fifth Medical Center of the PLA General Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: 4 years

Secondary Outcomes

Objective response rate (ORR)

ORR was defined as the proportion of patients with a complete response or a partial response

Time frame: 1year

Data from ClinicalTrials.gov

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