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

NCT ID: NCT01706432

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-15
• Study Completion Date: 2024-01-22

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

hyperfractionated radiation therapy

Intervention Type: RADIATION

Undergo hypofractionated radiation therapy

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

stereotactic radiosurgery

Intervention Type: RADIATION

Undergo stereotactic radiosurgery

Interventions

hyperfractionated radiation therapy

Undergo hypofractionated radiation therapy

Intervention Type: RADIATION

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

stereotactic radiosurgery

Undergo stereotactic radiosurgery

Intervention Type: RADIATION

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Chmura

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

North Chicago, Illinois, United States

Countries

United States

Other Identifiers

NCI-2011-03193

Identifier Type: REGISTRY

Identifier Source: secondary_id

16802B

Identifier Type: -

Identifier Source: org_study_id