We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01706432
Recruitment Status : Active, not recruiting
First Posted : October 15, 2012
Last Update Posted : December 23, 2021
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
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 Radiation: hyperfractionated radiation therapy Other: laboratory biomarker analysis Radiation: stereotactic radiosurgery

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biologic Endpoints in the Annihilation of Metastases for Oligometastasis (BEAM ON)
Actual Study Start Date : June 15, 2009
Actual Primary Completion Date : September 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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
Undergo hypofractionated radiation therapy

Other: laboratory biomarker analysis
Correlative studies

Radiation: stereotactic radiosurgery
Undergo stereotactic radiosurgery


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Progression free survival [ Time Frame: 5 years ]
  2. Overall survival [ Time Frame: 5 years ]
  3. Side effects of hypofractionated image guided radiotherapy [ Time Frame: During treatment (about 21 days) ]
  4. Number of patients with IRDS in tumor sample [ Time Frame: Day 1 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving radiation treatment for breast cancer.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706432


Locations
Layout table for location information
United States, Illinois
University of Chicago
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
University of Chicago
Investigators
Layout table for investigator information
Principal Investigator: Steven Chmura University of Chicago
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01706432    
Other Study ID Numbers: 16802B
NCI-2011-03193 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: December 23, 2021
Last Verified: December 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma in Situ
Breast Neoplasms, Male
Carcinoma, Ductal, Breast
Breast Carcinoma In Situ
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary