Skip to content

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

Efficacy of re-treatment of pyrotinib in HER2-positive recurrent or metastatic breast cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN93654271
Enrollment
360
Registered
2024-04-03
Start date
2023-09-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment for HER2-positive recurrent or metastatic breast cancer Cancer

Interventions

All patients included in the analysis have previously received a pyrotinib-containing regimen, with no restriction on the specific dosing regimen, and are fully guided by the physician's clinical choi

Sponsors

The Second Xiangya Hospital, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS) on the first pyrotinib treatment and PFS on re-treatment with pyrotinib) measured using patient records

Secondary

MeasureTime frame
Measured using patient records: 1. OS (overall survival) 2. ORR (objective response rate assessed by RECIST 1.1) 3. CBR (clinical benefit rate assessed by RECIST 1.1)

Countries

China

Contacts

Public ContactJing Peng
jingpeng@csu.edu.cn+86 15802590050

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026