Breast Cancer, Metastatic
Conditions
Keywords
conformal radiotherapy
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREHypofractionated Stereotactic Body Radiation Therapy
Hypofractionated Stereotactic Body Radiation Therapy
Sponsors
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 2 years | The percent of patients that survived from date of enrollment until 2 year follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Lesion Local Control | 6 years | Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure. |
| Number of Participants Who Experienced a Grade 4 or 5 Toxicity | 6 years | Number of participants who experienced a grade 4 or 5 toxicity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy 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. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 10 |
Baseline characteristics
| Characteristic | Hypofractionated Stereotactic Body Radiation Therapy |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 39 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Overall Survival
The percent of patients that survived from date of enrollment until 2 year follow-up visit.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Overall Survival | 74 percentage of participants |
Primary
Overall Survival
The percent of patients that survived from date of enrollment until 4 year follow-up visit
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Overall Survival | 54 percentage of participants |
Primary
Overall Survival
The percent of patients that survived from date of enrollment until 6 year follow-up visit
Time frame: 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Overall Survival | 47 percentage of participants |
Secondary
Number of Participants Who Experienced a Grade 4 or 5 Toxicity
Number of participants who experienced a grade 4 or 5 toxicity
Time frame: 6 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Number of Participants Who Experienced a Grade 4 or 5 Toxicity | 0 Participants |
Secondary
Percent of Patients With Lesion Local Control
Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure.
Time frame: 6 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Percent of Patients With Lesion Local Control | 87 percentage of participants |