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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01706432
First received: October 5, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

This pilot clinical trial studies 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 Intervention
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 Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biologic Endpoints in the Annihilation of Metastases for Oligometastasis (BEAM ON)

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Side effects of hypofractionated image guided radiotherapy [ Time Frame: During treatment (about 21 days) ] [ Designated as safety issue: Yes ]
  • Number of patients with IRDS in tumor sample [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2009
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (radiation therapy)
Patients with metastases in the lung, liver, abdomen, and extremities undergo 10 fractions or less of hypofractionated radiation therapy and patients with brain metastases undergo a single fraction of stereotactic radiosurgery.
Radiation: hyperfractionated radiation therapy
Undergo hypofractionated radiation therapy
Other: laboratory biomarker analysis
Correlative studies
Radiation: stereotactic radiosurgery
Undergo stereotactic radiosurgery

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of correlating changes in the number of circulating tumor cells in metastatic breast cancer patients with time to progression following hypofractionated image guided radiotherapy to all known sites (=< 5) of disease.

SECONDARY OBJECTIVES:

I. To determine the progression free survival, overall survival, pattern of failure, and toxicity of hypofractionated image guided radiotherapy to all active sites (=< 5) of metastatic disease.

II. To assess the feasibility of the Interferon-Related DNA Damage Resistance Gene Signature (IRDS) for its predictive value in treatment failure, both in and out of the radiation field.

OUTLINE:

Patients with metastases in the lung, liver, abdomen, and extremities undergo 10 fractions or less of hypofractionated radiation therapy and patients with brain metastases undergo a single fraction of stereotactic radiosurgery.

After completion of study treatment, patients are followed up every 2 weeks for 2 months, at 3 months, every 3 months for a year, and then every 6 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706432

Locations
United States, Illinois
University of Chicago
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Steven Chmura University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01706432     History of Changes
Other Study ID Numbers: 16802B, NCI-2011-03193
Study First Received: October 5, 2012
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Breast Neoplasms
Carcinoma in Situ
Breast Neoplasms, Male
Carcinoma, Ductal, Breast
Carcinoma
Carcinoma, Lobular
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on September 22, 2014