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

Launched by WANG SHUSEN · May 14, 2015

Keywords

ClinConnect Summary

This clinical trial is looking at whether a specific type of radiation treatment, called prophylactic cranial irradiation, can help women with advanced triple negative breast cancer who have responded well to their first round of chemotherapy. The main goal is to see if this treatment can help prevent cancer from spreading to the brain. The trial is not yet recruiting participants, but when it does, it will include women aged 18 to 65 who have been diagnosed with advanced breast cancer and have shown a positive response after receiving four to eight cycles of chemotherapy.

To be eligible for this trial, participants must be generally healthy with a good performance status (meaning they can carry out daily activities without much trouble) and have no major health issues that could interfere with the study. They should not have any other cancers, serious heart problems, or active brain cancer. If you or someone you know fits these criteria and is interested in learning more about this trial, it's important to discuss it with a healthcare provider to understand all the details and options available.

Gender

FEMALE

Eligibility 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)