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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-30

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

NCT03691051

HER2 Positive Metastatic Breast Cancer

UNKNOWN PHASE2

A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases

NCT05042791

HER2-positive Metastatic Breast Cancer

RECRUITING PHASE2

Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis

NCT06015100

Breast Cancer

UNKNOWN NA

Study Evaluating Pyrotinib in Combination With Capecitabine In Patients With HER2 Positive Metastatic Breast Cancer

NCT02361112

Metastatic Breast Cancer

COMPLETED PHASE1

Pyrotinib Combined With Capecitabine and Bevacizumab for Patients With HER2 Positive Breast Cancer and Brain Metastases

NCT06152822

Breast Cancer With Brain Metastases

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to assess the risk of HER2-positive advanced breast cancer patients with brain metastases. Efficacy of pyrotinib combined with capecitabine regimen in the real world, while evaluating the overall survival benefit of local therapy and drug therapy in patients with brain metastases.

The estimated sample size is 300 cases, and at least one group of cohort A, cohort B and cohort C is planned to exceed 100 cases; Cohort A - patients with 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 - group of patients with pyrotinib plus capecitabine after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy)。

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cohort A

new brain metastases directly treated with pyrotinib combined with capecitabine

No interventions assigned to this group

cohort B

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

No interventions assigned to this group

cohort C

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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;
2. 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;
3. 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
4. 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;
5. There are traceable medical history data.

Exclusion Criteria

1. Patients enrolled in the previous PERMEATE study;
2. The research program is receiving other anti-tumor drug treatment at the same time;
3. 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;
4. Pyrotinib combined with capecitabine in the treatment of non-brain metastases and progressive patients;
5. The investigator believes that the patient is not suitable to enter this study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No