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

Completed · Phase 2/Phase 3

Conditions studied: Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Metastatic Malignant Neoplasm in the Lymph Nodes, Metastatic Malignant Neoplasm in the Spine, Prognostic Stage IV Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8

In brief

This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumor cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

Key facts

Study ID

NCT02364557

Run by

NRG Oncology

People needed

129

Starts

2014-12-24

Expected to finish

2025-09-04

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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 percent volume receiving greater than or equal to 20 Gy (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 cluster of differentiation 4 (CD4) count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol

Where it is running

• CTCA at Western Regional Medical Center — Goodyear, Arizona, United States
• Arizona Center for Cancer Care-Peoria — Peoria, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• The Permanente Medical Group-Roseville Radiation Oncology — Roseville, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• Naval Medical Center -San Diego — San Diego, California, United States
• Kaiser Permanente Cancer Treatment Center — South San Francisco, California, United States
• Saint Joseph's Medical Center — Stockton, California, United States
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California, United States
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Banner North Colorado Medical Center - Loveland Campus — Loveland, Colorado, United States
• Helen F Graham Cancer Center — Newark, Delaware, United States
• UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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