Male Breast CarcinomaPhase 1NCT02206334
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
A Phase 1 study testing Stereotactic Body Radiation Therapy (SBRT) in people with Male Breast Carcinoma and Prostate Adenocarcinoma, run by NRG Oncology at 78 sites in 3 countries.
Trial summary
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Male Breast Carcinoma, Prostate Adenocarcinoma, Recurrent Breast Carcinoma
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 78 sitesin 3 countries
- Study dates
- Aug 2014to 20 May 2022
- Phase
- Phase 1
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR metastatic adenocarcinoma of the prostate; the sites of allowed metastases are: peripheral lung, central lung, mediastinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic
- NOTE: after the required number of evaluable patients have been accrued for a given dose level, the accrual for that metastatic location will be temporarily suspended while the safety of that dose level is assessed; a patient can only be entered onto the trial if all of their metastatic locations are open to accrual (e.g. if central lung is temporarily suspended for safety assessment and the patient has a central lung metastases, regardless of other metastases, they cannot enroll until the safety of dose to central lung is determined)
- Primary tumor site without progression at registration
- All metastases not resected must be amenable to SBRT
- The patient must meet ONE of the three following criteria:
- 3-4 radiographically distinct metastases of any distribution in the allowed anatomical sites OR
Show all 21Show fewer
- 2 radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR
- 3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s) having been surgically removed
- Evaluation by a radiation oncologist within 45 days prior to study registration
- Evaluation by a medical oncologist within 45 days prior to study registration
- The following imaging workup to document metastases within 45 days prior to study registration:
- Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT
- History/physical examination within 45 days prior to study registration
- Zubrod performance status =< 2 within 45 days prior to study registration
- Age >= 18 years
- Absolute neutrophil count (ANC) >= 500 cells/mm^3
- Platelets >= 50,000 /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)
- If liver metastases present, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 3 x upper limit of normal (ULN)
- Patient must provide study specific informed consent prior to study entry
- For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration
Who cannot join
- Progression of primary tumor site (breast, prostate, or lung) at time of registration
- Metastases with indistinct borders making targeting not feasible
- Known brain metastases
- Prior palliative radiotherapy to metastases
- Metastases located within 3 cm of the previously irradiated structures:
- Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)
Show all 21Show fewer
- 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)
- Brain stem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)
- Whole lung previously irradiated with prior volume 20 Gy (V20Gy) > 30% (delivered in =< 3 Gy/fraction)
- Primary tumor irradiated with SBRT
- Metastasis irradiated with SBRT
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
- Transmural myocardial infarction within the last 6 months prior to registration
- 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 within 30 days prior to registration
- Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
- 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
- End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
- Pregnancy or women of childbearing potential not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment
Trial locations and contacts
78 sites in 3 countries.
78 sites in 3 countries
United States74 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Ascension Saint Vincent Anderson
Anderson, Indiana, 46016
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Northwest Community Hospital
Arlington Heights, Illinois, 60005
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Boston Medical Center
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan, 48346
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Mercy Hospital
Coon Rapids, Minnesota, 55433
Decatur Memorial Hospital
Decatur, Illinois, 62526
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Henry Ford Hospital
Detroit, Michigan, 48202
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27710
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan, 48334
McLaren Cancer Institute-Flint
Flint, Michigan, 48532
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610
Self Regional Healthcare
Greenwood, South Carolina, 29646
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043
Virtua Memorial
Mount Holly, New Jersey, 08060
Cooper CyberKnife Center
Mount Laurel, New Jersey, 08054
Ogden Regional Medical Center
Ogden, Utah, 84405
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, 49770
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
Sutter Medical Center Sacramento
Sacramento, California, 95816
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Springfield Memorial Hospital
Springfield, Illinois, 62781
Washington University School of Medicine
St Louis, Missouri, 63110
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Community Medical Center
Toms River, New Jersey, 08755
Michigan Healthcare Professionals Troy
Troy, Michigan, 48098
Banner University Medical Center - Tucson
Tucson, Arizona, 85719
Virtua Voorhees
Voorhees Township, New Jersey, 08043
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069
Reading Hospital
West Reading, Pennsylvania, 19611
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the recommended stereotactic body radiation therapy (SBRT) dose for each of the metastatic locations being treated given the individual and overlapping fields when multiple metastases are treated with SBRT in a national clinical trials network setting.
SECONDARY OBJECTIVES:
- To estimate rates of >= grade 3 Common Terminology Criteria for Adverse Events (CTCAE), version (v.) 4.0 adverse events other than a dose-limiting toxicity (DLT) which is possibly, probably, or definitely related to treatment and which occurs within 6 months from the start of SBRT to multiple metastases.
II. To estimate the rates of long-term adverse events occurring up to 2 years from the end of SBRT.
III. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.
OUTLINE:
Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis.
After completion of study treatment, patients are followed up at 35-45 days and then every 3 months for 2 years.
- Conditions
- Male Breast Carcinoma, Prostate Adenocarcinoma, Recurrent Breast Carcinoma, Recurrent Non-Small Cell Lung Carcinoma, Recurrent Prostate Carcinoma, Stage IV Breast Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, Stereotactic Radiation Therapy, stereotactic radiosurgery
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Patients undergo 3-5 fractions of image-guided stereotactic body radiation therapy to all existing metastases over 1-3 weeks with at least 40 hours between treatments for an individual metastasis. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) scored according to the National Cancer Institute (NCI) CTCAE version 4.0 for each of 7 metastatic locations when multiple metastases are treated with SBRT
Adverse events outlined by metastatic location (full detail in protocol) reported as being probably or definitely related to protocol treatment.
Measured: Within 6 months from the start of treatment; for each of the 7 metastatic locations, analysis occurs after 6 evaluable patients have been followed for a minimum of 6 months from the start of treatment
Secondary outcomes (2)
Rate of long-term adverse events, scored according to the NCI CTCAE v. 4.0
Adverse events reported as being possibly, probably, or definitely related to protocol treatment.
Measured: Up to 2 years from end of treatment; analysis occurs after all patients have been potentially followed for 2 years from registration
Rates of >= grade 3 adverse events, scored according to NCI CTCAE v. 4.0
Adverse events (other than DLTs) reported as being possibly, probably, or definitely related to protocol treatment.
Measured: Within 6 months from the start of treatment; analysis occurs after all patients have been followed for a minimum of 6 months from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2018
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male Breast CarcinomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 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 Chmura, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206334
- Sponsor's protocol ID
- NRG-BR001
- Other IDs
- NCI-2014-00702, NRG-BR001, NRG-BR001, U10CA180868, U10CA021661
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2014
- Last updated
- 25 Jun 2026
- Results posted
- No
- 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
Chmura S, Winter KA, Robinson C, Pisansky TM, Borges V, Al-Hallaq H, Matuszak M, Park SS, Yi S, Hasan Y, Bazan J, Wong P, Yoon HA, Horton J, Gan G, Milano MT, Sigurdson ER, Moughan J, Salama JK, White J. Evaluation of Safety of Stereotactic Body Radiotherapy for the Treatment of Patients With Multiple Metastases: Findings From the NRG-BR001 Phase 1 Trial. JAMA Oncol. 2021 Jun 1;7(6):845-852. doi: 10.1001/jamaoncol.2021.0687.
PubMed 33885704