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

Completed

• Conditions: Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate; Mucinous Ductal Breast Carcinoma; Central Nervous System Metastases; Invasive Ductal Breast Carcinoma; Recurrent Breast Cancer; Invasive Lobular Breast Carcinoma With Predominant in Situ Component; Lobular Breast Carcinoma in Situ; Papillary Ductal Breast Carcinoma; Invasive Ductal Breast Carcinoma With Predominant Intraductal Component; Invasive Lobular Breast Carcinoma
• Interventions: Radiation: hyperfractionated radiation therapy; Other: laboratory biomarker analysis; Radiation: stereotactic radiosurgery

• Registration Number: NCT01706432
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-06-15
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-15
• Primary Completion: 2024-01-22
• Study Completion: 2024-01-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	hyperfractionated radiation therapy	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
All participants	stereotactic radiosurgery	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
All participants	laboratory biomarker analysis	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 North Chicago, Illinois, United States