Pyrotinib Combined With Capecitabine in HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)

NCT05359120 | Unknown

• 1 other identifier: HNCH-MBC09-BM03
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases.

Conditions

Breast Cancer

Keywords

HER-2 positive advanced breast cancer; pyrotinib; capecitabine

Outcome Measures

Primary Outcomes (1)

• Time to Failure(TTF)

  Time from initiation of study protocol treatment to treatment failure or study protocol discontinuation for any reason (including discontinuation due to patient request, disease progression, adverse events, or death)

  up to 2 years

Secondary Outcomes (7)

• Progression-free survival(PFS)

  up to 2 years

• CNS-DCR

  up to 2 years

• CNS-CBR

  up to 2 years

• CNS-ORR

  up to 2 years

• CNS-DOR

  up to 2 years

Study Arms (3)

cohort A

new brain metastases directly treated with pyrotinib combined with capecitabine

cohort B

whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine

cohort C

after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy) treated with pyrotinib combined with capecitabine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases of patients with brain metastases from HER2-positive advanced breast cancer who received pyrotinib combined with capecitabine from July 2018 to December 2022.

You may qualify if:

• Pathologically diagnosed patients with HER-2 expression-positive advanced breast cancer; Note: Positive HER2 expression refers to at least one tumor cell immunohistochemical staining intensity of 3+ or fluorescence in situ hybridization \[FISH\] in the pathological detection/recheck of the primary or metastatic lesions performed by the pathology department of the participating central hospital confirmed positive;
• Brain metastases are diagnosed by MRI/enhanced CT imaging, according to RECIST 1.1 criteria, with or without measurable lesions and with or without symptoms of brain metastases;
• Pyrotinib combined with capecitabine in the treatment of brain metastases with non-PD evaluation at the first treatment, at least ≥ 2 continuous imaging reports or assessments
• For previous treatment regimens, no previous use of capecitabine or progression after capecitabine discontinuation for 6 months, or progression after discontinuation of capecitabine adjuvant therapy for one year or more;
• There are traceable medical history data.

You may not qualify if:

• Patients enrolled in the previous PERMEATE study;
• The research program is receiving other anti-tumor drug treatment at the same time;
• The initial dose of pyrotinib is lower than the minimum dose in the instructions (240 mg), and the capecitabine is 50% lower than the standard dose;
• Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;
• The investigator believes that the patient is not suitable to enter this study.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Min Yan

CONTACT

15713857388; ym200678@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 3, 2022
• Study Start: May 30, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Three years from publication
• Access Criteria: Please contact Central contact person by Email

Locations

CN (1)