Standard of Care Therapy with or without Stereotactic Radiosurgery and / or Surgery in Treating Patients with Limited Metastatic Breast Cancer

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 205-934-0220
Email: tmyrick@uab.edu

Arizona

Goodyear
CTCA at Western Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 623-207-3000
Tucson
Banner University Medical Center - Tucson
Status: Active
Contact: Site Public Contact
Email: aselegue@email.arizona.edu
University of Arizona Cancer Center-North Campus
Status: Active
Contact: Site Public Contact
Phone: 800-327-2873
University of Arizona Cancer Center-Orange Grove Campus
Status: Active
Contact: Site Public Contact
Phone: 520-694-8900

California

Berkeley
Alta Bates Summit Medical Center-Herrick Campus
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
Los Angeles
Los Angeles County-USC Medical Center
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 323-865-0451
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Sutter Medical Center Sacramento
Status: Active
Contact: Site Public Contact
Phone: 415-209-2686
Email: bernicl@sutterhealth.org
University of California Davis Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 916-734-3089
South San Francisco
Kaiser Permanente Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Saint Joseph's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 209-461-5257
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 530-582-6450

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650
Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Fort Collins
Poudre Valley Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 970-297-6150
Loveland
McKee Medical Center
Status: Active
Contact: Site Public Contact
Phone: 303-777-2663
Email: ccrp@co-cancerresearch.org

Delaware

Newark
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: Active
Contact: Site Public Contact
Phone: 954-265-1847
Email: OHR@mhs.net
Jacksonville
Mayo Clinic in Florida
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Orlando
UF Cancer Center at Orlando Health
Status: Active
Contact: Site Public Contact
Phone: 321-841-7246
Email: CancerClinicalTrials@orlandohealth.com
Pembroke Pines
Memorial Hospital West
Status: Active
Contact: Site Public Contact
Phone: 954-265-4325

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: Active
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
Status: Active
Contact: Site Public Contact
Phone: 888-946-7447
Columbus
John B Amos Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 706-478-7968
Email: cdean@iacthealth.com
Newnan
CTCA at Southeastern Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 770-400-6629
Thomasville
Lewis Hall Singletary Oncology Center
Status: Active
Contact: Site Public Contact
Phone: 888-823-5923
Email: ctsucontact@westat.com

Hawaii

Honolulu
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-545-8548
The Cancer Center of Hawaii-Liliha
Status: Active
Contact: Site Public Contact
Phone: 808-547-6881

Illinois

Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Rush University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Decatur
Decatur Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Maywood
Loyola University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 708-226-4357
Springfield
Memorial Medical Center
Status: Active
Contact: Site Public Contact
Phone: 217-788-3528
Swansea
Southwest Illinois Health Services LLP
Status: Active
Contact: Site Public Contact
Phone: 618-236-1000
Email: lynns@thecancercenter.com
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Active
Contact: Site Public Contact
Phone: 630-315-1918
Email: Claudine.Gamster@CadenceHealth.org
Zion
Midwestern Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Indiana

Anderson
Saint Vincent Anderson Regional Hospital / Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 317-338-2194
Email: research@stvincent.org
Muncie
IU Health Ball Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 765-751-5850
South Bend
Memorial Hospital of South Bend
Status: Active
Contact: Site Public Contact
Phone: 800-284-7370

Kansas

Wichita
Ascension Via Christi Hospitals Wichita
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org

Maine

Bath
MaineHealth Coastal Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org
Biddeford
MaineHealth / SMHC Cancer Care and Blood Disorders-Biddeford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org
Portland
Maine Medical Center-Bramhall Campus
Status: Active
Contact: Site Public Contact
Phone: 207-885-7565
Sanford
MaineHealth / SMHC Cancer Care and Blood Disorders-Sanford
Status: Active
Contact: Site Public Contact
Email: LLemire@mmc.org
MaineHealth Cancer Care Center of York County
Status: Active
Contact: Site Public Contact
Phone: 207-459-1600
Scarborough
Maine Medical Center- Scarborough Campus
Status: Active
Contact: Site Public Contact
Phone: 207-396-8090
Email: wrighd@mmc.org

Maryland

Baltimore
Greater Baltimore Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-849-3706
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-888-8823
Bel Air
UM Upper Chesapeake Medical Center
Status: Active
Contact: Site Public Contact
Phone: 443-643-3010
Columbia
Central Maryland Radiation Oncology in Howard County
Status: Active
Contact: Site Public Contact
Phone: 443-546-1300

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 781-744-8027
Lowell
Lowell General Hospital
Status: Active
Contact: Site Public Contact
Phone: 978-788-7084
Email: ghincks@lowellgeneral.org

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Brownstown
Henry Ford Cancer Institute-Downriver
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Clarkston
21st Century Oncology MHP - Clarkston
Status: Active
Contact: Site Public Contact
Phone: 248-338-0663
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Farmington Hills
21st Century Oncology MHP - Farmington
Status: Active
Contact: Site Public Contact
Phone: 248-338-0663
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Pontiac
Saint Joseph Mercy Oakland
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Royal Oak
William Beaumont Hospital-Royal Oak
Status: Active
Contact: Site Public Contact
Phone: 248-551-7695
Troy
21st Century Oncology MHP - Troy
Status: Active
Contact: Site Public Contact
Phone: 248-338-0663
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org

Minnesota

Coon Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Duluth
Saint Luke's Hospital of Duluth
Status: Active
Contact: Site Public Contact
Phone: 218-249-7825
Email: kdean@slhduluth.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: Active
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Saint Louis
Mercy Hospital South
Status: Active
Contact: Site Public Contact
Email: janet.lesko@mercy.net
Missouri Baptist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 314-996-5569
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu

Montana

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nevada

Reno
Renown Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org

New Hampshire

Dover
Wentworth-Douglass Hospital
Status: Active
Contact: Site Public Contact
Phone: 603-740-2150

New Jersey

Toms River
Community Medical Center
Status: Active
Contact: Site Public Contact
Phone: 732-818-3882

New Mexico

Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 505-272-0530
Email: AYost@nmcca.org
Lovelace Radiation Oncology
Status: Active
Contact: Site Public Contact
Phone: 505-272-0530
Email: AYost@nmcca.org
New Mexico Oncology Hematology Consultants
Status: Active
Contact: Site Public Contact
Phone: 505-272-0530
Email: CLee@nmcca.org
University of New Mexico Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 505-925-0366
Email: LByatt@nmcca.org
Santa Fe
Christus Saint Vincent Regional Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 505-913-8933
Email: Olivia.Sloan@nmcancercare.com

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 212-305-6361
Email: nr2616@cumc.columbia.edu
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Cary
Rex Hematology Oncology Associates-Cary
Status: Active
Contact: Site Public Contact
Phone: 919-784-7209
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Garner
Rex Hematology Oncology Associates-Garner
Status: Active
Contact: Site Public Contact
Phone: 919-784-7209
Raleigh
Rex Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 919-784-7209
Rex Cancer Center of Wakefield
Status: Active
Contact: Site Public Contact
Phone: 919-784-7209
Rex Hematology Oncology Associates-Blue Ridge
Status: Active
Contact: Site Public Contact
Phone: 919-784-7209
Supply
NHRMC Radiation Oncology - Supply
Status: Active
Contact: Site Public Contact
Phone: 910-754-4716
Wilmington
New Hanover Regional Medical Center / Zimmer Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 910-342-3000
NHRMC Radiation Oncology - 16th Street
Status: Active
Contact: Site Public Contact
Phone: 910-251-1839
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

Ohio

Akron
Cleveland Clinic Akron General
Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Email: CancerAnswer@ccf.org
Cleveland
Case Western Reserve University
Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Email: CTUReferral@UHhospitals.org
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-220-4937
Email: cancer@lhs.org
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Pennsylvania

Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: Active
Contact: Site Public Contact
Phone: 717-724-6765
Email: klitchfield@PINNACLEHEALTH.org
Pittsburgh
Allegheny General Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-284-2000
UPMC-Shadyside Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-621-2334
Sayre
Guthrie Medical Group PC-Robert Packer Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-836-0388

South Carolina

Greenwood
Self Regional Healthcare
Status: Active
Contact: Site Public Contact
Phone: 864-725-4771
Email: nmcgaha@selfregional.org
Greer
Gibbs Cancer Center-Pelham
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org
Spartanburg
Spartanburg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Email: kmertz-rivera@gibbscc.org

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: Active
Contact: Site Public Contact
Phone: 214-648-7097
Email: canceranswerline@UTSouthwestern.edu
Houston
M D Anderson Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Email: askmdanderson@mdanderson.org

Utah

Ogden
Ogden Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Email: Roster@nrgoncology.org

Virginia

Falls Church
Inova Fairfax Hospital
Status: Active
Contact: Site Public Contact
Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org
Richmond
Bon Secours Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Phone: 804-893-8611
Email: Melissa_Godsey@bshsi.org

Washington

Vancouver
Legacy Salmon Creek Hospital
Status: Active
Contact: Site Public Contact
Phone: 503-413-2150

West Virginia

Huntington
Edwards Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 304-399-6617
Morgantown
West Virginia University Healthcare
Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Email: cancertrialsinfo@hsc.wvu.edu

Wisconsin

Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
Saint Vincent Hospital Cancer Center Green Bay
Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Email: Christy.Gilchrist@hshs.org
La Crosse
Gundersen Lutheran Medical Center
Status: Active
Contact: Site Public Contact
Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org
Milwaukee
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-4380
Stevens Point
Marshfield Clinic Stevens Point Center
Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org
West Bend
The Alyce and Elmore Kraemer Cancer Care Center
Status: Active
Contact: Site Public Contact
Phone: 866-680-0505
Weston
Diagnostic and Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 888-799-3989
Email: oncology.clinical.trials@marshfieldresearch.org

Alberta

Calgary
Tom Baker Cancer Centre
Status: Active
Contact: Site Public Contact
Phone: 403-521-3433
Edmonton
Cross Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 780-432-8500

Ontario

London
London Regional Cancer Program
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 519-685-8600
Ottawa
Ottawa Hospital and Cancer Center-General Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 613-761-4395

Quebec

Montreal
CHUM - Centre Hospitalier de l'Universite de Montreal
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 514-890-8000ext12725
Email: info.cr.chum@ssss.gouv.qc.ca
CHUM - Hopital Notre-Dame
Status: Active
Contact: Giuseppina Laura Masucci
Phone: 514-890-8000ext23611
Email: sylvie.beaudoin.chum@ssss.gouv.qc.ca
Jewish General Hospital
Status: Active
Contact: Site Public Contact
Phone: 514-340-8222ext8248
McGill University Department of Oncology
Status: Active
Contact: Tarek Hijal
Phone: 514-934-1934ext42953
Email: evelyn.ortega@muhc.mcgill.ca

Korea, Republic of

Seoul
Yonsei University Health System-Severance Hospital
Status: Active
Contact: Site Public Contact
Email: ihcc@yuhs.ac

Saudi Arabia

Riyadh
King Faisal Specialist Hospital and Research Centre
Status: Active
Contact: Site Public Contact
Phone: 011-966-1-464-7272 ext 38005

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. 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. (Phase II-R)

II. To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS). (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate treated metastasis control according to tumor receptor status (estrogen receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor [HER]-2), 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.

TERTIARY OBJECTIVES:

I. 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.

II. 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.

III. 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.

IV. 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.

V. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS.

VI. To store material for retrospective analysis of circulating tumor deoxyribonucleic acid (ctDNA).

VII. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician.

ARM 2: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician. Patients also undergo stereotactic radiosurgery in 1, 3, or 5 fractions within 3 weeks and/or surgery at the discretion of the treating physician.

ARM 1: Patients are followed every 3 months from randomization to 2 years.

ARM 2: Patients are followed 25-35 days post-ablation, every 3 months from randomization to 2 years, and then yearly thereafter.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
NRG Oncology

Principal Investigator
Steven J. Chmura

Trial IDs

Primary ID NRG-BR002
Secondary IDs NCI-2014-01810
Clinicaltrials.gov ID NCT02364557