The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
Official Title: A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma
Study ID: NCT01082211
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
Detailed Description: OBJECTIVES: Primary * 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. Secondary * To evaluate the adverse events occurring after 1 year from the completion of re-irradiation and at any time. * 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 radiotherapy. After completion of study therapy, patients are followed up periodically for 4-5 years and then every year thereafter.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Arizona Center for Cancer Care - Peoria, Peoria, Arizona, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center, Burbank, California, United States
University of Colorado Cancer Center at UC Health Sciences Center, Aurora, Colorado, United States
JFK Medical Center, Atlantis, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States
Cancer Institute at St. John's Hospital, Springfield, Illinois, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
St. Agnes Hospital Cancer Center, Baltimore, Maryland, United States
Central Maryland Oncology Center, Columbia, Maryland, United States
Tate Cancer Center at Baltimore Washington Medical Center, Glen Burnie, Maryland, United States
Cape Cod Hospital, Hyannis, Massachusetts, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
McLaren Cancer Institute, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
Barnes-Jewish West County Hospital, Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center - Basking Ridge, Basking Ridge, New Jersey, United States
St. Barnabas Medical Center Cancer Center, Livingston, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States
Sands Cancer Center, Canandaigua, New York, United States
Memorial Sloan-Kettering Cancer Center, Commack, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York, United States
Highland Hospital of Rochester, Rochester, New York, United States
University Radiation Oncology at Parkridge Hospital, Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
Memorial Sloan-Kettering Cancer Center - Rockville Centre, Rockville Centre, New York, United States
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Barberton Citizens Hospital, Barberton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Flower Hospital Cancer Center, Sylvania, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital, Abington, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Community Memorial Hospital Cancer Care Center, Menomonee Falls, Wisconsin, United States
Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin, United States
Columbia-Saint Mary's Cancer Care Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
Name: Douglas W. Arthur, MD
Affiliation: Massey Cancer Center
Role: PRINCIPAL_INVESTIGATOR