Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer

Sponsor

University of Chicago (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01706432

Collaborator

(none)

Enrollment

Location

155.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central 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	Radiation: hyperfractionated radiation therapy Other: laboratory biomarker analysis Radiation: stereotactic radiosurgery

Study Design

Study Type:

Observational

Actual Enrollment :

4 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 15, 2009

Actual Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
All participants Patients will undergo standard of care radiation therapy and have research blood samples collected at following time points: pre-treatment 3-4 weeks post-treatment every 9-12 weeks post-treatment for 1 year	Radiation: hyperfractionated radiation therapy Undergo hypofractionated radiation therapy Other: laboratory biomarker analysis Correlative studies Radiation: stereotactic radiosurgery Undergo stereotactic radiosurgery

Arm

Intervention/Treatment

All participants

Patients will undergo standard of care radiation therapy and have research blood samples collected at following time points: pre-treatment 3-4 weeks post-treatment every 9-12 weeks post-treatment for 1 year

Radiation: hyperfractionated radiation therapy

Undergo hypofractionated radiation therapy

Other: laboratory biomarker analysis

Correlative studies

Radiation: stereotactic radiosurgery

Undergo stereotactic radiosurgery

Outcome Measures

Primary Outcome Measures

Change in the number of circulating tumor cells [At baseline, 3-4 weeks post-treatment, and every 9-12 weeks for one year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Platelets >= 100,000 cells/mm^3
Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
Total bilirubin within institutional limits
Albumin > 2.9 g/dl
Alkaline phosphatase < 2.5x upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
Room air saturation (saturated oxygen [Sa02]) > 90%
Life expectancy > 3 months
Patient complete study specific informed consent process and sign consent form prior to study entry
Patients with prior metastatic treatment are eligible if they have been disease free for > 3 years; participants may receive hormonal and Herceptin treatment at any time

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
Pregnancy, breast feeding or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for at least three months following completion; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Prior treatment with anti-angiogenic therapy
Significant atelectasis such that CT definition of the gross tumor volume (GTV) is difficult to determine
Exudative, bloody or cytologically malignant effusions
Evidence of pleural or pericardial effusion prior to study start; patients with pleural effusion that is transudative, cytologically negative, and non-bloody are eligible; if a pleural effusion is too small for diagnostic thoracentesis, the patient will be eligible