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

NCT01706432 | Completed

• 2 other identifiers: 16802BNCI-2011-03193
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in the number of circulating tumor cells

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

Secondary Outcomes (4)

• 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

Study Arms (1)

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; Other: laboratory biomarker analysis; Radiation: stereotactic radiosurgery

Interventions

hyperfractionated radiation therapy RADIATION

Undergo hypofractionated radiation therapy

All participants

laboratory biomarker analysis OTHER

Correlative studies

All participants

stereotactic radiosurgery RADIATION

Undergo stereotactic radiosurgery

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving radiation treatment for breast cancer.

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

North Chicago, Illinois, 60064, United States

Location

MeSH Terms

Conditions

Carcinoma, Ductal, Breast; Carcinoma, Lobular; Breast Carcinoma In Situ; Breast Neoplasms, Male; Breast Neoplasms; Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Steven Chmura

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 15, 2012
• Study Start: June 15, 2009
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (1)