This trial is active, not recruiting.

Conditions 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
Treatments hyperfractionated radiation therapy, laboratory biomarker analysis, stereotactic radiosurgery
Sponsor University of Chicago
Collaborator National Cancer Institute (NCI)
Start date June 2009
End date June 2017
Trial size 24 participants
Trial identifier NCT01706432, 16802B, NCI-2011-03193


This pilot clinical trial studies 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

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
Patients with metastases in the lung, liver, abdomen, and extremities undergo 10 fractions or less of hypofractionated radiation therapy and patients with brain metastases undergo a single fraction of stereotactic radiosurgery.
hyperfractionated radiation therapy
Undergo hypofractionated radiation therapy
laboratory biomarker analysis
Correlative studies
stereotactic radiosurgery
Undergo stereotactic radiosurgery

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Biologic Endpoints in the Annihilation of Metastases for Oligometastasis (BEAM ON)
Principal investigator Steven Chmura
Description PRIMARY OBJECTIVES: I. To evaluate the feasibility of correlating changes in the number of circulating tumor cells in metastatic breast cancer patients with time to progression following hypofractionated image guided radiotherapy to all known sites (=< 5) of disease. SECONDARY OBJECTIVES: I. To determine the progression free survival, overall survival, pattern of failure, and toxicity of hypofractionated image guided radiotherapy to all active sites (=< 5) of metastatic disease. II. To assess the feasibility of the Interferon-Related DNA Damage Resistance Gene Signature (IRDS) for its predictive value in treatment failure, both in and out of the radiation field. OUTLINE: Patients with metastases in the lung, liver, abdomen, and extremities undergo 10 fractions or less of hypofractionated radiation therapy and patients with brain metastases undergo a single fraction of stereotactic radiosurgery. After completion of study treatment, patients are followed up every 2 weeks for 2 months, at 3 months, every 3 months for a year, and then every 6 months thereafter.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Chicago.