| Eligibility |
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
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