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

wang shusen

Status: Not yet enrolling

Conditions: Breast Cancer; Brain Metastasis

Treatments: Radiation: prophylactic cranial irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02448576

SYSU-5010-TNBC-PCI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 326 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent;
2. Age of 18 to 65 years;
3. Documented advanced breast cancer, clinical and pathological confirmed;
4. Immunohistochemical examination:ER<1%+, progestin receptor (PR)<1%+, HER-2 -/+ or HER-2(++)with negative result of FISH;
5. A response after four to eight cycles of first line chemotherapy;
6. Life expectancy longer than six months evaluated by investigator;
7. 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)
8. Less than grade 1( Common Terminology Criteria grade version 4.0) of treatment-related toxicities;
9. Adequate baseline organ function.

Exclusion criteria

1. History of another malignancy.
2. Pregnancy or gestation
3. Definite diagnosed of central nervous system (CNS)or leptomeningeal metastases
4. Serious cardiac illness or medical condition
5. Known history of related central nervous system or leptomeningeal disease
6. Cognition impairment or suffering from mental illness
7. Demand a long-term oral administration of psychotropic drugs
8. 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

PCI group

Experimental group

Description:

Receiving prophylactic cranial irradiation after response to first line chemotherapy.

Treatment:

Radiation: prophylactic cranial irradiation

observation group

No Intervention group

Description:

Patients in the observation group do not receive prophylactic cranial irradiation after response to first line chemotherapy.