A Prospective Randomized Controlled Clinical Trial of Prophylactic Cranial Irradiation in Metastatic HER-2 positive Breast Cancer.

Phase 3

Recruiting

• Conditions: Metastatic HER- 2 positive breast cancer patientsRisk of brain metastasis; PCI; HER2 positive; Metastatic breast cancer

• Registration Number: TCTR20170612001
• Lead Sponsor: Ratchadapiseksompotch research fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-12
• Study Completion: 2019-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

1.MetastaticHER-2 positive breast cancer patients who had HER-2 positive on immunohistochemistry or fluorescence in situ hybridization test.
2.No brain metastasis is noted
3.Eastern Cooperative Oncology Group (ECOG) performance status <=2
4.More than 18 years of age.
5.General physical conditions must be compatible with the radio-therapeutic treatment.
6.Patients give permissions literally in the study informed consent form prior to participation.
7. The blood tests have to be fulfilled of WBC >=3000, platelet >=100,000, creatinine <=1.5 mg/do, creatinine clearance >=60ml/min

Exclusion Criteria

1. History of previous cranial radiation or neurosurgery
2 .History of cerebrovascular disease or neurological disorder including seizure.
3 .Known or suspected brain or meningeal metastasis by present of signs of raised intra-cranial pressure, seizure, focal symptom, cognitive dysfunction and proved by MRI to have brain metastases.
4 .Patient with CNS disease.
5 .Active untreated infection which increases risk of treatment complication.
6 .Major medical or psychiatric illnesses that would affect to the outcome, completion of therapy, the follow up and without potential in understand the side effects and risks of the therapy.
7 .pregnant women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of symptomatic brain metastasis patients have sign/symptom suggesting brain metastasis MRI brain

Secondary Outcome Measures

Name	Time	Method
CNS relapse free survival 1 and 2 year Follow up patients without symptom and sign of brain metastasis,overall survival 1 and 2 year Follow up ,cognitive function every 3 months MOCA test ,neurologic toxicity every 3 months CTCAE