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

• ClinicalTrials.gov Identifier: NCT01706432
• Recruitment Status: Active, not recruiting
• First Posted: October 15, 2012
• Last Update Posted: December 23, 2021
• Sponsor: University of Chicago
• Information provided by (Responsible Party): University of Chicago

Tracking Information

• First Submitted Date: October 5, 2012
• First Posted Date: October 15, 2012
• Last Update Posted Date: December 23, 2021
• Actual Study Start Date: June 15, 2009
• Actual Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 11, 2012): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 11, 2012)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Hypofractionated Image Guided Radiation Therapy in Treating Patients With Stage IV Breast Cancer
• Official Title: Biologic Endpoints in the Annihilation of Metastases for Oligometastasis (BEAM ON)
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients receiving radiation treatment for breast cancer.

Condition

• 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

Intervention

• Radiation: hyperfractionated radiation therapy
  Undergo hypofractionated radiation therapy
• Other: laboratory biomarker analysis
  Correlative studies
• Radiation: stereotactic radiosurgery
  Undergo stereotactic radiosurgery

Study Groups/Cohorts

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

Interventions:

• Radiation: hyperfractionated radiation therapy
• Other: laboratory biomarker analysis
• Radiation: stereotactic radiosurgery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 16, 2020): 4
• Original Estimated Enrollment (submitted: October 11, 2012): 24
• Estimated Study Completion Date: June 2022
• Actual Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01706432
• Other Study ID Numbers: 16802B; NCI-2011-03193 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Chicago
• Original Responsible Party: Steven Chmura, MD, University of Chicago, Asst Prof Radiation & Cellular Oncology
• Current Study Sponsor: University of Chicago
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Steven Chmura; University of Chicago

• PRS Account: University of Chicago
• Verification Date: December 2021