This trial is active, not recruiting.

Condition breast cancer, metastatic
Treatments hypofractionated stereotactic body radiation therapy
Phase phase 2
Sponsor University of Rochester
Start date December 2000
End date October 2021
Trial size 49 participants
Trial identifier NCT00167414, URCC 8700


The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.
hypofractionated stereotactic body radiation therapy
Hypofractionated Stereotactic Body Radiation Therapy
hypofractionated stereotactic body radiation therapy
Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.

Primary Outcomes

Overall survival
time frame: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years

Secondary Outcomes

Response (clinical, chemical [CA 27-29] and radiological), and quality of life correlation with pro-apoptotic, inflammatory, and anabolic cytokine profiles
time frame: 30 months from date of registration

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Age: no limit - Karnofsky performance status (KPS) ≥ 70 - No more than 5 metastatic sites involving one or more different organs (liver, lung or bone). - The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol. - Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. - Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist. - Informed consent must be obtained. - Pregnancy test must be negative for women of child bearing potential Exclusion Criteria: - Inability of patient to be followed longitudinally as specified by protocol. - Technical inability to achieve required dose based on safe dose constraints required for radiosurgery. - Women who are pregnant or nursing. - Failure to meet requirements in Inclusion Criteria - Contraindications to radiation.

Additional Information

Official title A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
Principal investigator Hong Zhang, MD
Description Before treatment begins, you will have a physical exam and blood tests. Physical evaluations and blood tests will be done each week while you are receiving treatment, and at follow-up visits. You will be seen for follow-up evaluations 4 weeks after treatment is completed, and every three months thereafter. You will be asked to fill out a Quality of Life questionnaire, which should take 5-10 minutes to complete. This will be done prior to treatment and at your follow-up visits. You will receive high dose radiation therapy directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Rochester.