Sponsor:
SWOG Cancer Research Network
Code:
NCT07578116
Conditions
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic HER2-Positive Breast Carcinoma
Oligometastatic Breast Carcinoma
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Biopsy Procedure
Biospecimen Collection
Breast Conservation Treatment
Computed Tomography
Cyclin-Dependent Kinase 4 Inhibitor
Brief summary:
Conditions
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic HER2-Positive Breast Carcinoma
Oligometastatic Breast Carcinoma
Study ID
NCT07578116
Start date
Mar 9, 2027
Status verified date
Oct, 2026
Completion date
May 31, 2033
Anticipated
Primary completion date
May 31, 2032
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
562 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Treatment
Arms
experimental: Step 1 (HER2-targeted systemic therapy, STS/SRT)
experimental: Step 2 Cohort A, Arm 1 (locoregional, SBRT, systemic therapy)
experimental: Step 2 Cohort A, Arm 2 (systemic therapy)
experimental: Step 2 Cohort B (systemic therapy)
Interventions
Biopsy Procedure
Biospecimen Collection
Breast Conservation Treatment
Computed Tomography
Cyclin-Dependent Kinase 4 Inhibitor
Cyclin-Dependent Kinase 6 Inhibitor
Echocardiography Test
HER2-targeted Therapy
Hormone Therapy
Magnetic Resonance Imaging
Mammography
Pertuzumab
Positron Emission Tomography
Radiation Boost
Radiation Therapy
Stereotactic Body Radiation Therapy
Stereotactic Radiosurgery
Taxane Compound
Total Mastectomy
Trastuzumab
Trastuzumab Deruxtecan
Trastuzumab Emtansine
Ultrasound Imaging
Primary outcome measure
Locations
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Recruiting
Jonesboro, Arkansas, United States, 72401
Contacts
Principal Investigator:
Philip E. Lammers
Smilow Cancer Hospital-Derby Care Center
Recruiting
Derby, Connecticut, United States, 06418
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital Care Center-Fairfield
Recruiting
Fairfield, Connecticut, United States, 06824
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital Care Center at Greenwich
Recruiting
Greenwich, Connecticut, United States, 06830
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital Care Center - Guilford
Recruiting
Guilford, Connecticut, United States, 06437
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital-Hamden Care Center
Recruiting
Hamden, Connecticut, United States, 06518
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Center/Yale-New Haven Hospital
Recruiting
New Haven, Connecticut, United States, 06510
Contacts
Principal Investigator:
Mariya Rozenblit
Yale University
Recruiting
New Haven, Connecticut, United States, 06520
Contacts
Principal Investigator:
Mariya Rozenblit
Yale-New Haven Hospital North Haven Medical Center
Recruiting
North Haven, Connecticut, United States, 06473
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital Care Center at Long Ridge
Recruiting
Stamford, Connecticut, United States, 06902
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital-Torrington Care Center
Recruiting
Torrington, Connecticut, United States, 06790
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital Care Center-Trumbull
Recruiting
Trumbull, Connecticut, United States, 06611
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital-Waterbury Care Center
Recruiting
Waterbury, Connecticut, United States, 06708
Contacts
Principal Investigator:
Mariya Rozenblit
Smilow Cancer Hospital Care Center - Waterford
Recruiting
Waterford, Connecticut, United States, 06385
Contacts
Principal Investigator:
Mariya Rozenblit
Orlando Health Cancer Institute
Recruiting
Orlando, Florida, United States, 32806
Contacts
Principal Investigator:
Shane R. Stecklein
OSF Saint Joseph Medical Center
Recruiting
Bloomington, Illinois, United States, 61701
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Bloomington
Recruiting
Bloomington, Illinois, United States, 61704
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Canton
Recruiting
Canton, Illinois, United States, 61520
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Carthage
Recruiting
Carthage, Illinois, United States, 62321
Contacts
Principal Investigator:
Bryan A. Faller
Cancer Care Specialists of Illinois - Decatur
Recruiting
Decatur, Illinois, United States, 62526
Contacts
Principal Investigator:
Bryan A. Faller
Decatur Memorial Hospital
Recruiting
Decatur, Illinois, United States, 62526
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Eureka
Recruiting
Eureka, Illinois, United States, 61530
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Galesburg
Recruiting
Galesburg, Illinois, United States, 61401
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Kewanee Clinic
Recruiting
Kewanee, Illinois, United States, 61443
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Macomb
Recruiting
Macomb, Illinois, United States, 61455
Contacts
Principal Investigator:
Bryan A. Faller
Cancer Care Center of O'Fallon
Recruiting
O'Fallon, Illinois, United States, 62269
Contacts
Principal Investigator:
Bryan A. Faller
HSHS Saint Elizabeth's Hospital
Recruiting
O'Fallon, Illinois, United States, 62269
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Ottawa Clinic
Recruiting
Ottawa, Illinois, United States, 61350
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Pekin
Recruiting
Pekin, Illinois, United States, 61554
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Peoria
Recruiting
Peoria, Illinois, United States, 61615
Contacts
Principal Investigator:
Bryan A. Faller
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Recruiting
Peoria, Illinois, United States, 61615
Contacts
Principal Investigator:
Bryan A. Faller
OSF Saint Francis Medical Center
Recruiting
Peoria, Illinois, United States, 61637
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Peru
Recruiting
Peru, Illinois, United States, 61354
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare-Princeton
Recruiting
Princeton, Illinois, United States, 61356
Contacts
Principal Investigator:
Bryan A. Faller
Southern Illinois University School of Medicine
Recruiting
Springfield, Illinois, United States, 62702
Contacts
Site Public Contact
217-545-7929Principal Investigator:
Bryan A. Faller
Springfield Clinic
Recruiting
Springfield, Illinois, United States, 62702
Contacts
Site Public Contact
800-444-7541Principal Investigator:
Bryan A. Faller
Springfield Memorial Hospital
Recruiting
Springfield, Illinois, United States, 62781
Contacts
Principal Investigator:
Bryan A. Faller
Illinois CancerCare - Washington
Recruiting
Washington, Illinois, United States, 61571
Contacts
Principal Investigator:
Bryan A. Faller
Mercy Cancer Center-West Lakes
Recruiting
Clive, Iowa, United States, 50325
Contacts
Site Public Contact
515-241-3305Principal Investigator:
Richard L. Deming
Iowa Methodist Medical Center
Recruiting
Des Moines, Iowa, United States, 50309
Contacts
Site Public Contact
515-241-6727Principal Investigator:
Seema Harichand-Herdt
Broadlawns Medical Center
Recruiting
Des Moines, Iowa, United States, 50314
Contacts
Site Public Contact
515-282-2200Principal Investigator:
Seema Harichand-Herdt
Mercy Medical Center - Des Moines
Recruiting
Des Moines, Iowa, United States, 50314
Contacts
Site Public Contact
515-241-3305Principal Investigator:
Richard L. Deming
Mercy Medical Center-West Lakes
Recruiting
West Des Moines, Iowa, United States, 50266
Contacts
Site Public Contact
515-241-3305Principal Investigator:
Richard L. Deming
Ascension Via Christi Hospitals Wichita
Recruiting
Wichita, Kansas, United States, 67214
Contacts
Principal Investigator:
Dennis F. Moore
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Recruiting
Columbus, Mississippi, United States, 39705
Contacts
Principal Investigator:
Philip E. Lammers
Baptist Cancer Center-Grenada
Recruiting
Grenada, Mississippi, United States, 38901
Contacts
Principal Investigator:
Philip E. Lammers
Baptist Memorial Hospital and Cancer Center-Union County
Recruiting
New Albany, Mississippi, United States, 38652
Contacts
Principal Investigator:
Philip E. Lammers
Baptist Memorial Hospital and Cancer Center-Oxford
Recruiting
Oxford, Mississippi, United States, 38655
Contacts
Principal Investigator:
Philip E. Lammers
Saint Francis Medical Center
Recruiting
Cape Girardeau, Missouri, United States, 63703
Contacts
Principal Investigator:
Bryan A. Faller
Thomas Jefferson University Hospital
Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contacts
Principal Investigator:
Elena Shagisultanova
Asplundh Cancer Pavilion
Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contacts
Principal Investigator:
Elena Shagisultanova
Smilow Cancer Hospital Care Center - Westerly
Recruiting
Westerly, Rhode Island, United States, 02891
Contacts
Principal Investigator:
Mariya Rozenblit
Lexington Health
Recruiting
West Columbia, South Carolina, United States, 29169
Contacts
Principal Investigator:
Steven A. Madden
Baptist Memorial Hospital and Cancer Center-Collierville
Recruiting
Collierville, Tennessee, United States, 38017
Contacts
Principal Investigator:
Philip E. Lammers
Baptist Memorial Hospital and Cancer Center-Memphis
Recruiting
Memphis, Tennessee, United States, 38120
Contacts
Principal Investigator:
Philip E. Lammers
Bon Secours Memorial Regional Medical Center
Recruiting
Mechanicsville, Virginia, United States, 23116
Contacts
Principal Investigator:
William J. Irvin
Bon Secours Saint Francis Medical Center
Recruiting
Midlothian, Virginia, United States, 23114
Contacts
Principal Investigator:
William J. Irvin
Bon Secours Saint Mary's Hospital
Recruiting
Richmond, Virginia, United States, 23226
Contacts
Principal Investigator:
William J. Irvin
Bon Secours Cancer Institute at Reynolds Crossing
Recruiting
Richmond, Virginia, United States, 23230
Contacts
Principal Investigator:
William J. Irvin
Sponsor
SWOG Cancer Research Network
Last update posted
Oct 13, 2026
Last verified
Oct, 2026
Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.