A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma
- To evaluate skin, breast, and chest wall adverse events occurring within 1 year after
completion of 3D-conformal partial-breast re-irradiation following repeat
breast-preserving surgery in patients with locally recurrent breast carcinoma.
- To evaluate the adverse events at 1 year and at any time of this regimen in these
- To evaluate in-breast control rate in patients treated with this regimen.
- To evaluate freedom-from-mastectomy rate in these patients.
- To evaluate the rate of circulating tumor cells (CTCs) in this patient population and
to document eradication of CTCs by locoregional therapy.
- To determine whether translational objective will correlate with eradication or
presence of CTCs with in-breast recurrence and distant metastasis-free survival.
- To evaluate cosmesis as judged by the patient and independent evaluation.
- To evaluate distant metastasis-free survival, mastectomy-free survival, and overall
survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily,
5 days a week, for 3 weeks.
Some patients undergo blood sample collection at baseline and within 3 weeks after
completion of radiotherapy for circulating tumor cells analysis.
Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following
After completion of study therapy, patients are followed up periodically for 4-5 years and
then every year thereafter.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Grade 3+ treatment-related skin, fibrosis, and breast pain adverse events
From the end of radiation to 1 year.
Douglas W. Arthur, MD
Massey Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Saint Joseph Mercy Cancer Center||Ann Arbor, Michigan 48106-0995|
|Van Elslander Cancer Center at St. John Hospital and Medical Center||Grosse Pointe Woods, Michigan 48236|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|Cape Cod Hospital||Hyannis, Massachusetts 02601|
|Albert Einstein Cancer Center||Philadelphia, Pennsylvania 19141|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Monmouth Medical Center||Long Branch, New Jersey 07740-6395|
|McDowell Cancer Center at Akron General Medical Center||Akron, Ohio 44307|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Battle Creek Health System Cancer Care Center||Battle Creek, Michigan 49017|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Butterworth Hospital at Spectrum Health||Grand Rapids, Michigan 49503-2560|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|St. Barnabas Medical Center Cancer Center||Livingston, New Jersey 07039|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||New York, New York 10032|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton||Marlton, New Jersey 08053|
|Rosenfeld Cancer Center at Abington Memorial Hospital||Abington, Pennsylvania 19001|
|Fox Chase Cancer Center - Philadelphia||Philadelphia, Pennsylvania 19111-2497|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Highland Hospital of Rochester||Rochester, New York 14620|
|Delaware County Regional Cancer Center at Delaware County Memorial Hospital||Drexel Hill, Pennsylvania 19026|
|Seton Cancer Institute at Saint Mary's - Saginaw||Saginaw, Michigan 48601|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Barberton Citizens Hospital||Barberton, Ohio 44203|
|Flower Hospital Cancer Center||Sylvania, Ohio 43560|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||Reading, Pennsylvania 19612-6052|
|Community Memorial Hospital Cancer Care Center||Menomonee Falls, Wisconsin 53051|
|Cancer Institute at St. John's Hospital||Springfield, Illinois 62701|
|JFK Medical Center||Atlantis, Florida 33462|
|Lacks Cancer Center at Saint Mary's Health Care||Grand Rapids, Michigan 49503|
|University of Colorado Cancer Center at UC Health Sciences Center||Aurora, Colorado 80045|
|Central Maryland Oncology Center||Columbia, Maryland 21044|
|Columbia Saint Mary's Hospital - Ozaukee||Mequon, Wisconsin 53097|
|Columbia-Saint Mary's Cancer Care Center||Milwaukee, Wisconsin 53211|
|St. Agnes Hospital Cancer Center||Baltimore, Maryland 21229|
|Barnes-Jewish West County Hospital||Saint Louis, Missouri 63141|
|Sands Cancer Center||Canandiaqua, New York 14424|
|University Radiation Oncology at Parkridge Hospital||Rochester, New York 14626|
|Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center||Burbank, California 91505|
|Arizona Center for Cancer Care - Peoria||Peoria, Arizona 85381|
|McLaren Cancer Institute||Flint, Michigan 48532|
|Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center||Sleepy Hollow, New York 10591|
|Tate Cancer Center at Baltimore Washington Medical Center||Glen Burnie, Maryland 21061|
|Memorial Sloan-Kettering Cancer Center - Basking Ridge||Basking Ridge, New Jersey 07920|
|Memorial Sloan-Kettering Cancer Center - Rockville Centre||Rockville Centre, New York 11570|