Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8Phase 2/3NCT02364557
Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival
A Phase 2/3 study testing Stereotactic Body Radiotherapy and Surgery in people with Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8 and Metastatic Breast Carcinoma, run by NRG Oncology at 162 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone
- What is being tested?
- Stereotactic Body Radiotherapy and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 162 sitesin 4 countries
- Study dates
- 24 Dec 2014to 4 Sep 2025
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
162 sites in 4 countries.
162 sites in 4 countries
United States153 sites
Cleveland Clinic Akron General
Akron, Ohio, 44307
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Lovelace Radiation Oncology
Albuquerque, New Mexico, 87109
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Ascension Saint Vincent Anderson
Anderson, Indiana, 46016
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Hospital
Atlanta, Georgia, 30309
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Texas Oncology-Austin Midtown
Austin, Texas, 78705
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
UNC Health Cancer Care Cary
Cary, North Carolina, 27518
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612
University of Illinois
Chicago, Illinois, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan, 48346
Case Western Reserve University
Cleveland, Ohio, 44106
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044
John B Amos Cancer Center
Columbus, Georgia, 31904
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mercy Hospital
Coon Rapids, Minnesota, 55433
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Decatur Memorial Hospital
Decatur, Illinois, 62526
Henry Ford Hospital
Detroit, Michigan, 48202
Wentworth-Douglass Hospital
Dover, New Hampshire, 03820
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805
Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan, 48334
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
UNC Health Cancer Care Garner
Garner, North Carolina, 27529
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Self Regional Healthcare
Greenwood, South Carolina, 29646
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Queen's Medical Center
Honolulu, Hawaii, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
UT MD Anderson Cancer Center
Houston, Texas, 77030
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Logan Health Medical Center
Kalispell, Montana, 59901
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Los Angeles General Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539
Lowell General Hospital
Lowell, Massachusetts, 01854
Loyola University Medical Center
Maywood, Illinois, 60153
Miami Cancer Institute
Miami, Florida, 33176
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Virtua Memorial
Mount Holly, New Jersey, 08060
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Helen F Graham Cancer Center
Newark, Delaware, 19713
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, 30265
Ogden Regional Medical Center
Ogden, Utah, 84405
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Orlando Health Cancer Institute
Orlando, Florida, 32806
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303
Memorial Hospital West
Pembroke Pines, Florida, 33028
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Rex Hematology Oncology Associates-Blue Ridge
Raleigh, North Carolina, 27607
UNC Health Cancer Care Raleigh
Raleigh, North Carolina, 27607
UNC Health Cancer Care Wakefield
Raleigh, North Carolina, 27614
Renown Regional Medical Center
Reno, Nevada, 89502
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Sutter Medical Center Sacramento
Sacramento, California, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Regions Hospital
Saint Paul, Minnesota, 55101
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Naval Medical Center -San Diego
San Diego, California, 92134
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, 04073
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Springfield Memorial Hospital
Springfield, Illinois, 62781
Washington University School of Medicine
St Louis, Missouri, 63110
Mercy Hospital South
St Louis, Missouri, 63128
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Saint Joseph's Medical Center
Stockton, California, 95204
Novant Cancer Institute Radiation Oncology - Supply
Supply, North Carolina, 28462
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226
ProMedica Flower Hospital
Sylvania, Ohio, 43560
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Lewis Hall Singletary Oncology Center
Thomasville, Georgia, 31792
Community Medical Center
Toms River, New Jersey, 08755
Michigan Healthcare Professionals Troy
Troy, Michigan, 48098
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Carle Cancer Center
Urbana, Illinois, 61801
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686
Virtua Voorhees
Voorhees Township, New Jersey, 08043
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Reading Hospital
West Reading, Pennsylvania, 19611
Dickstein Cancer Treatment Center
White Plains, New York, 10601
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, 28401
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Midwestern Regional Medical Center
Zion, Illinois, 60099
Canada7 sites
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
London Regional Cancer Program
London, Ontario, N6A 4L6
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211
South Korea1 site
Yonsei University Health System-Severance Hospital
Seoul, 120-752
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Phase II: To determine whether ablation [through stereotactic body radiation therapy (SBRT) (stereotactic radiosurgery) and/or surgical resection of all known metastases] in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial.
II. Phase III: To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS).
SECONDARY OBJECTIVES:
- To evaluate treated metastasis control according to tumor receptor status [estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2)], use of chemotherapy, surgery versus (vs.) ablative therapy, and number of metastases.
II. To evaluate whether the addition of ablative metastasis directed therapy significantly reduces the number of distant recurrences (new metastases) in patients who progress according to tumor receptor status (ER, PR, HER-2); use of chemotherapy, and number of metastases.
III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy compared with those treated with standard medical therapy alone.
EXPLORATORY OBJECTIVE:
- To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout the radiation therapy processes, including imaging, simulation, target and critical structure definition, treatment planning, image guidance, and delivery.
TRANSLATIONAL RESEARCH OBJECTIVES:
- To determine whether < 5 circulating tumor cells (CTCs) (per 7.5 ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer.
II. To determine whether < 5 CTCs (per 7.5 ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer.
III. To determine whether eliminating CTCs (0/7.5 ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS.
IV. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS.
- To store material for retrospective analysis of circulating tumor deoxyribonucleic acid (ctDNA).
VI. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA).
- 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
- Being tested
- Stereotactic Body Radiotherapy, Surgery
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiotherapyRadiation
Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, Stereotactic Radiosurgery
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.
SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | Standard of care systemic therapy at the discretion of the treating physician. |
| Standard of Care + Ablation | Experimental | Standard of care systemic therapy plus ablation of all metastases by stereotactic body radiotherapy or surgery at the discretion of the treating physician. Receives: Radiation: Stereotactic Body Radiotherapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (Phase II)
Progression (failure) is defined as any of the following: progression of metastases, new metastases, or death. Progression-free survival (PFS) time is defined as time from randomization to the date of first progression, death, or last contact when participant had a documented clinical assessment (censored). PFS rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Median PFS is provided.
Measured: From randomization to last follow-up. Follow-up schedule: 3 mos after randomization and every 3 months to 24 months, then every six months to five years, then annually. Maximum follow-up at time of analysis was 63 months.
Overall Survival (Phase III)
Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored).
Measured: From randomization to last follow-up. Follow-up schedule: 3 mos after randomization and every 3 months to 24 months and then annually. Maximum follow-up at time of analysis was 63 months.
Secondary outcomes (4)
Percentage of Participants With Treated Metastasis Progression on the SOC + Ablation Arm
Metastasis progression (failure) is defined as the clearance and subsequent recurrence or the development of new metastases in the treated area. Failure time is defined as time from randomization to the date of first failure, last contact when participant had a documented clinical assessment (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. Two-year failure rates are provided here.
Measured: From randomization to last follow-up. Follow-up schedule: 3 months after randomization, every 3 months up to 24 months, every six months up to five years, then annually. Maximum follow-up at time of analysis was 63 months. Two-year rates are provide here.
Percentage of Participants With New Metastases
New metastases (failure) is defined as the appearance of any new metastases. Failure time is measured from randomization to the date of first failure, last contact when participant had a documented clinical assessment (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year failure rates are provided here
Measured: From randomization to last follow-up. Follow-up schedule: 3 months after randomization, every 3 months up to 24 months, every six months up to five years, then annually. Maximum follow-up at time of analysis was 63 months.Two-year rates are provided here.
Number of Patients by Highest Grade Adverse Event Reported
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Measured: From randomization to last follow-up. Follow-up schedule: Arm 1: 3 mos. after randomization / Arm 2: weekly during SBRT and the last day of SBRT; both arms: then every 3 mos. to 24 mos., then annually. Maximum follow-up at time of analysis was 63 months.
Progression-free Survival in the Presence or Absence of Circulating Tumor Cells (CTCs)
The presence of CTCs is defined as ≥ 5 CTCs (per 7.5ml of blood). Progression (failure) is defined as any of the following: progression of metastases, new metastases, or death. Progression-free survival (PFS) time is defined as time from randomization to the date of first progression, death, or last contact when participant had a documented clinical assessment (censored). PFS rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the groups, which is reported in the statistical analysis results. Two-year PFS rates are provided here
Measured: From randomization to last follow-up. Follow-up schedule: 3 months after randomization, every 3 months up to 24 months, every six months up to five years, then annually. Maximum follow-up at time of analysis was 63 months.Two-year rates are provided here.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study start24 Dec 2014
- Primary completion20 Dec 2021
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8Studies of the same condition, open and under way.
- More trials run by NRG OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- NRG Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven J Chmura, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364557
- Sponsor's protocol ID
- NRG-BR002
- Other IDs
- NCI-2014-01810, NRG-BR002, NRG-BR002, NRG-BR002, U10CA180868
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2015
- Last updated
- 10 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Publications
Petrelli F, Ghidini A, Ghidini M, Bukovec R, Trevisan F, Turati L, Indini A, Seghezzi S, Lonati V, Moleri G, Tomasello G, Zaniboni A. Better survival of patients with oligo- compared with polymetastatic cancers: a systematic review and meta-analysis of 173 studies. F1000Res. 2021 May 27;10:423. doi: 10.12688/f1000research.52546.4. eCollection 2021.
PubMed 35602670