Biologic Endpoints in the Annihilation of Metastases for Oligometastasis (BEAM ON)

University of Chicago1 site in 1 country4 target enrollmentJune 15, 2009

ConditionsCentral Nervous System Metastases Invasive Ductal Breast Carcinoma Invasive Ductal Breast Carcinoma With Predominant Intraductal Component Invasive Lobular Breast Carcinoma Invasive Lobular Breast Carcinoma With Predominant in Situ Component Liver Metastases Lobular Breast Carcinoma in Situ Lung Metastases Male Breast Cancer Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate Mucinous Ductal Breast Carcinoma Papillary Ductal Breast Carcinoma Recurrent Breast Cancer Stage IV Breast Cancer Tubular Ductal Breast Carcinoma Tumors Metastatic to Brain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Central Nervous System Metastases
Sponsor: University of Chicago
Enrollment: 4
Locations: 1
Primary Endpoint: Change in the number of circulating tumor cells
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This pilot clinical trial studies new ways to monitor the impact of hypofractionated image guided radiation therapy in treating patients with stage IV breast cancer. Radiation therapy uses high energy x rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

Registry

clinicaltrials.gov

Start Date

June 15, 2009

End Date

January 22, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically proven diagnosis of breast cancer (invasive ductal, lobular, medullary, papillary, colloid, tubular)
•Completion of standard of care treatment for local and regional disease with no known residual
•American Joint Committee on Cancer (AJCC) (6th edition, 2002) Stage IV ( Any T, Any N, M1) based upon the following minimum diagnostic workup:
•History/physical examination within 8 weeks prior to registration
•Computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET) CT of the whole body within 60 days prior to registration
•MRI of the brain, if clinically indicated
•Documentation of 1-5 sites of metastatic tumor; each individual site of tumor must be =\< 10 cm or \< 500 cc volume and amenable to radiation therapy as seen on standard imaging (CT, MRI, bone scan)
•Pathology from at least one metastatic site confirming breast primary is recommended
•Zubrod performance status =\< 2 (Karnofsky \>= 60%)
•Absolute neutrophil count (ANC) \>= 1,800 cells/mm\^3

Exclusion Criteria

•Patients are ineligible if they have had prior treatment for their metastatic disease within 3 years
•Prior radiotherapy that would result in overlap of radiation therapy fields
•Co-existing or prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
•Severe, active co-morbidity, defined as follows:
•Clinically significant pulmonary dysfunction, cardiomyopathy, any history of clinically significant congestive heart failure (CHF), unstable angina pectoris, or cardiac arrhythmia
•Transmural myocardial infarction within the last 6 months
•Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
•Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
•Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
•Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immunocompromised patients

Outcomes

Primary Outcomes

Change in the number of circulating tumor cells

Time Frame: At baseline, 3-4 weeks post-treatment, and every 9-12 weeks for one year

Secondary Outcomes

Progression free survival(5 years)
Overall survival(5 years)
Side effects of hypofractionated image guided radiotherapy(During treatment (about 21 days))
Number of patients with IRDS in tumor sample(Day 1)