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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	Female

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02448576
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	wang shusen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Shusen Wang
Principal Investigator Affiliation	Sun Yat-sen University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Brain Metastasis

Additional Details

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.

Arms & Interventions

Arms

Experimental: PCI group

Receiving prophylactic cranial irradiation after response to first line chemotherapy.

No Intervention: observation group

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

Interventions

Radiation: - prophylactic cranial irradiation

Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, Guangdong, China

Status

Address

State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060

Site Contact

fei xu, M.D.

xufei@sysucc.org.cn

862087342693

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