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NCT02364557

PHASE2/PHASE3

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

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2014-12-24

Completion Date

2025-09-04

Last Updated

2026-07-10

Healthy Volunteers

Conditions

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

Interventions

RADIATION

Stereotactic Body Radiotherapy

Patients receive 1, 3, or 5 fractions of radiation, beginning within 6 weeks of study entry. * For metastases in the peripheral lung, patients receive a single fraction of 30 Gy or 3 fractions for a total of 45 Gy. * For a single liver metastases, patients receive a single fraction of 30 Gy. * For metastases in the abdominal-pelvic or liver (\>1), patients receive 3 fractions for a total of 45 Gy. * For metastases in the central lung or mediastinal/ cervical lymph nodes, patients receive 5 fractions for a total of 50 Gy. * For spinal metastases, patients receive 1 fraction of 20 Gy. * For non-spinal osseous metastases, patients receive 3 fractions for a total of 30 Gy. * For thoracic/cervical spine metastases, patients receive 5 fractions for a total of 35 Gy.

PROCEDURE

Surgery

All surgical resections will be approached with intent of an R0 resection (rendering the patient with no evidence of measureable disease and pathologic negative margin) and must occur within 6 weeks of study entry. Approach to surgery will be based upon the treating surgeon. An open, laparoscopic, or thorascopic approach is acceptable.

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 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

Locations (162)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

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

Mayo Clinic in Florida

Jacksonville, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Memorial Hospital West

Pembroke Pines, Florida, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, United States

Lewis Hall Singletary Oncology Center

Thomasville, Georgia, United States

Queen's Medical Center

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Northwestern University

Chicago, Illinois, United States

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Midwestern Regional Medical Center

Zion, Illinois, United States

Ascension Saint Vincent Anderson

Anderson, Indiana, United States

Parkview Hospital Randallia

Fort Wayne, Indiana, United States

Parkview Regional Medical Center

Fort Wayne, Indiana, United States

IU Health Ball Memorial Hospital

Muncie, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, United States

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, United States

MaineHealth Maine Medical Center - Biddeford

Biddeford, Maine, United States

MaineHealth Maine Medical Center - Portland

Portland, Maine, United States

MaineHealth Cancer Care and IV Therapy - Sanford

Sanford, Maine, United States

MaineHealth Cancer Care Center of York County

Sanford, Maine, United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Lowell General Hospital

Lowell, Massachusetts, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Michigan Healthcare Professionals Troy

Troy, Michigan, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Saint Luke's Hospital of Duluth

Duluth, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Renown Regional Medical Center

Reno, Nevada, United States

Wentworth-Douglass Hospital

Dover, New Hampshire, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Virtua Memorial

Mount Holly, New Jersey, United States

Community Medical Center

Toms River, New Jersey, United States

Virtua Voorhees

Voorhees Township, New Jersey, United States

Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

And 62 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (162)