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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20170612001

Enrollment

235

Registered

2017-06-12

Start date

2017-06-06

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Metastatic HER&#45

Interventions

observe brain metastatic symptoms and cognitive function every 3 months,PCI dose of 30 gray in 15 fractions with hippocampal sparing technique. Treatments are delivered once daily&#44

5 fractions per week over 3 weeks with minimal interruptions.

No Intervention No treatment,Experimental Radiation

observe,Prophylactic Cranial irradiation

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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 =3000, platelet >=100,000, creatinine =60ml/min

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
incidence of symptomatic brain metastasis patients have sign/symptom suggesting brain metastasis MRI brain	—

Secondary

Measure	Time frame
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	—

Countries

Thailand

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026

A Prospective Randomized Controlled Clinical Trial of Prophylactic Cranial Irradiation in Metastatic HER&#45;2 positive Breast Cancer.