PCI in Advanced Triple Negative Breast Cancer Patients Who Response to 1st Line Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study is to compare whether prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy could prolong brain-metastasis free survival.

Detailed Description
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This is a phase III, randomized, controlled, open, multicenter clinical trial, designed to assess the efficacy and safety of prophylactic cranial irradiation (PCI) in advanced triple negative breast cancer who response to the first line chemotherapy. Compare the PCI group with the observation group to evaluate brain metastasis-free survival,cumulative risk of brain metastases within 1 year,progression-free survival,overall survival,quality of life measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-cancer 30 (EORTC-QLQ-C30) questionnaire score and function of central nervous measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-brain cancer 20 (EORTC-QLQ-BN20) questionnaire score in women with advanced triple negative breast cancer who response to the first line chemotherapy.

Official Title
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A Phase III Randomized Controlled Trial of Prophylactic Cranial Irradiation in Patients With Advanced Triple Negative Breast Cancer Who Had a Response to First Line Chemotherapy

Conditions
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Breast Cancer, Brain Metastasis

Intervention / Treatment
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* Radiation: prophylactic cranial irradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent; Age of 18 to 65 years; Documented advanced breast cancer, clinical and pathological confirmed; Immunohistochemical examination:ER<1%+, progestin receptor (PR)<1%+, HER-2 -/+ or HER-2(++)with negative result of FISH; A response after four to eight cycles of first line chemotherapy; Life expectancy longer than six months evaluated by investigator; A performance status of 0 to 2, according to the criteria of the World Health Organization (with a higher score indicating a poorer performance status) Less than grade 1( Common Terminology Criteria grade version 4.0) of treatment-related toxicities; Adequate baseline organ function. Exclusion Criteria: History of another malignancy. Pregnancy or gestation Definite diagnosed of central nervous system (CNS)or leptomeningeal metastases Serious cardiac illness or medical condition Known history of related central nervous system or leptomeningeal disease Cognition impairment or suffering from mental illness Demand a long-term oral administration of psychotropic drugs Have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCI group<br>Receiving prophylactic cranial irradiation after response to first line chemotherapy. | Radiation: prophylactic cranial irradiation<br>* Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy<br>|
| No Intervention: observation group<br>Patients in the observation group do not receive prophylactic cranial irradiation after response to first line chemotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain metastasis-free survival | time from randomization to brain metastasis | eight years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative risk of brain metastases within 1 year | the percent of subjects occurring brain metastases with 1 year | one year | 
| progression-free survival | time from randomization to disease progression or death(upon which happen earlier) | eight years | 
| overall survival | time from randomization to death | eight years | 
| life quality score | quality of life measured by the EORTC-QLQ-C30 questionnaire score | eight years | 
| central nervous function score | function of central nervous measured by the EORTC-QLQ-BN20 questionnaire score | eight years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phase 3 randomized controlled trial, prophylactic cranial irradiation, triple negative breast cancer, brain metastasis, advanced breast cancer