Re-treatment of pyrotinib in HER2-positive recurrent or metastatic breast cancer: a retrospective study

Phase 4

• Conditions: Treatment for HER2-positive recurrent or metastatic breast cancer; Cancer

• Registration Number: ISRCTN93654271
• Lead Sponsor: The Second Xiangya Hospital, Central South University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Last Update Posted: 15 April 2024
• Study Completion: 2025-02-27

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Patients aged =18 years and <80 years.
2. Patients diagnosed with recurrent or metastatic breast cancer as HER2-positive by pathology testing (HER2-positive is defined as an immunohistochemistry (IHC) score of 3+ or 2+ for HER2 and a positive in-situ hybridization (ISH) test confirmed by a pathology laboratory).
3. Have received at least two lines of pyrotinib-containing regimens in advanced stages.
4. Have at least 2 months or more of follow-up data from the initiation of the pyrotinib-containing regimen to the point of data collection.
5. Presence of a measurable lesion as defined by the revised Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
6. Adequate hematologic, hepatic, and renal functions.

Exclusion Criteria

1. Pyrotinib medication use as neoadjuvant therapy.
2. Severe adverse side effects could not be controlled by dose reductions according to drug instructions.
3. Loss to follow-up for other unknown reasons.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) on the first pyrotinib treatment and PFS on re-treatment with pyrotinib) measured using patient records

Secondary Outcome Measures

Name	Time	Method
Measured using patient records:<br>1. OS (overall survival)<br>2. ORR (objective response rate assessed by RECIST 1.1)<br>3. CBR (clinical benefit rate assessed by RECIST 1.1)