Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival

Inclusion Criteria:

A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
Pathologically confirmed metastatic breast cancer

Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis;

Note: estrogen, progesterone and HER2 status of metastasis preferred for stratification

Number of allowable metastases:

=< 4 metastases seen on standard imaging within 60 days prior to registration when all metastatic disease is located within the following sites:

Peripheral lung
Osseous (bone)
Spine
Central lung
Abdominal-pelvic metastases (lymph node/adrenal gland)
Liver
Mediastinal/cervical lymph node

All known disease amenable to metastasis-directed therapy with either SBRT or resection

NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered
NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites
NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
Maximum diameter of individual metastasis in any dimension =< 5 cm
There are no restrictions on distance between the metastases
Patients must be registered within 365 days of the initial metastatic breast cancer diagnosis; first-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2, or other standard targeted therapy) for metastatic breast cancer must be given or planned to be given; if given before study entry, it cannot have exceeded a duration of 12 months at the time of registration (Note: sequencing of ablative therapy [surgery or SBRT] relative to systemic therapy, for patients randomized to Arm 2, is at the discretion of the treating physician)

The primary tumor site must be controlled prior to registration

For those who present with synchronous primary and oligometastatic disease, primary must be controlled prior to registration
The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference For those who present with local recurrence and oligometastatic disease, local recurrence must be controlled prior to registration
The definition of control is definitive surgery by excision or mastectomy (+/- radiotherapy) per institution preference

Appropriate stage for study entry based on the following diagnostic workup:

History/physical examination within 60 days prior to registration
Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60 days prior to study registration
Zubrod performance status =< 2 within 60 days prior to registration
Blood cell count (CBC)/differential obtained within 60 days prior to registration on study
Absolute neutrophil count (ANC) >= 500 cells/mm^3
Platelets >= 50,000 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)
For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria:

Patients with any of the following conditions are NOT eligible for this study.
Pathologic evidence of active primary disease or local/regional breast tumor recurrence at the time of registration;
Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be reported

Metastases with indistinct borders making targeting not feasible

NOTE: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required
Prior palliative radiation treatment for metastatic disease to be treated on the protocol (including radiopharmaceuticals)

Metastases located within 3 cm of the previously irradiated structures:

Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)
Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)
Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)
Brainstem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)
Whole lung previously irradiated with prior V20Gy > 30% (delivered in =< 3 Gy/fraction)
Primary tumor irradiated with SBRT
Metastasis irradiated with SBRT
Brain metastases
Exudative, bloody, or cytological proven malignant effusions

Severe, active co-morbidity defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
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
Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible
Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol