NCT04767828

A Single Arm Study of Brain Metastasis in Patients With HER2-positive Breast Cancer

A Single Arm Study of Brain Metastasis in Patients With HER2-positive Breast Cancer Treated With Pyrrolidine Maleate and Capecitabine Combined With Brain Radiotherapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the progression time and efficacy of brain tumors in patients with brain metastases from HER2-positive breast cancer treated with Pyrrolidine and Capecitabine combined with brain radiotherapy.

Detailed description

Brain metastases are very common in HER2-positive breast cancer patients. The vast majority of patients with metastatic brain tumors are in advanced stages of the disease. If not treated in time, the natural course of the disease is extremely short. At present, the main treatment of brain metastases from breast cancer is radiotherapy, combined with chemotherapy and targeted therapy drugs. On the basis of previous clinical studies, the aim of this study was to explore the efficacy and safety of combined brachytherapy with Pyrrotidine and Capecitabine in patients with brain metastases from HER2-positive breast cancer, in order to provide a new, safer and more effective treatment for patients with brain metastases from breast cancer.

Conditions

• TTP

Interventions

Type	Name	Description
DRUG	PYRROTINI	CAPECITABINE: 800 mg/m2 twice daily, taken orally within 30 minutes after meal (one in the morning and one in the evening, 12 hours apart, equal to a daily dose of 1600 mg/m2, with one dose in the morning and one dose in the morning) .
RADIATION	Brain radiation therapy	Brain radiation therapy: the dose and frequency of brain radiation therapy are determined by the doctor according to the patient's condition.

Timeline

• Start date: 2020-05-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-02-23
• Last updated: 2021-02-23

Locations

1 site across 1 country: China