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Brief Title: Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer
Official Title: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer
Study ID: NCT03598257
Brief Summary: This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.
Detailed Description: PRIMARY OBJECTIVE: I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes. SECONDARY OBJECTIVE: I. To compare the effect of concurrent administration of olaparib with radiotherapy versus radiotherapy alone on improvement in locoregional control (measured by locoregional recurrence-free interval), distant relapse-free survival, and overall survival in inflammatory breast cancer patients. ADDITIONAL OBJECTIVE: I. To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive olaparib orally (PO) twice daily (BID) the day before standard radiation therapy (RT) commences (Day 0) and throughout the RT course until the last day of RT administration. Olaparib is also continued on weekends (routine days without RT) throughout the RT course. Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. GROUP II: Patients undergo standard radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up within 5 weeks, then every 3 months until 3 years after registration, and then every 6 months for up to 8 years after registration.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas, United States
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States
Epic Care Partners in Cancer Care, Emeryville, California, United States
Los Angeles General Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Fremont - Rideout Cancer Center, Marysville, California, United States
Desert Regional Medical Center, Palm Springs, California, United States
Palo Alto Medical Foundation Health Care, Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Mission Hope Medical Oncology - Santa Maria, Santa Maria, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee, California, United States
Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Shaw Cancer Center, Edwards, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Beebe South Coastal Health Campus, Frankford, Delaware, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, United States
George Washington University Medical Center, Washington, District of Columbia, United States
Mount Sinai Comprehensive Cancer Center at Aventura, Aventura, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Sacred Heart Hospital, Pensacola, Florida, United States
Tampa General Hospital, Tampa, Florida, United States
Grady Health System, Atlanta, Georgia, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
The Cancer Center of Hawaii-Pali Momi, 'Aiea, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
HSHS Saint Elizabeth's Hospital, O'Fallon, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
IU Health West Hospital, Avon, Indiana, United States
IU Health North Hospital, Carmel, Indiana, United States
IU Health Central Indiana Cancer Centers-Fishers, Fishers, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
IU Health Methodist Hospital, Indianapolis, Indiana, United States
McFarland Clinic - Ames, Ames, Iowa, United States
Mercy Cancer Center-West Lakes, Clive, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
Salina Regional Health Center, Salina, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
Wesley Medical Center, Wichita, Kansas, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
LSU Health Sciences Center at Shreveport, Shreveport, Louisiana, United States
Lafayette Family Cancer Center-EMMC, Brewer, Maine, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Trinity Health Medical Center - Brighton, Brighton, Michigan, United States
Trinity Health Medical Center - Canton, Canton, Michigan, United States
Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States
Beaumont Hospital - Dearborn, Dearborn, Michigan, United States
Beaumont Hospital - Farmington Hills, Farmington Hills, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
University of Michigan Health - Sparrow Lansing, Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
Ascension Providence Hospitals - Novi, Novi, Michigan, United States
Michigan Healthcare Professionals Pontiac, Pontiac, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Ascension Providence Hospitals - Southfield, Southfield, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
William Beaumont Hospital - Troy, Troy, Michigan, United States
University of Michigan Health - West, Wyoming, Michigan, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Gulfport Memorial Hospital, Gulfport, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Oxford, Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven, Mississippi, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Saint Luke's Hospital, Chesterfield, Missouri, United States
University of Kansas Cancer Center - North, Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit, Lee's Summit, Missouri, United States
Mercy Hospital South, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Bozeman Health Deaconess Hospital, Bozeman, Montana, United States
Benefis Sletten Cancer Institute, Great Falls, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC, Omaha, Nebraska, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
The Valley Hospital - Luckow Pavilion, Paramus, New Jersey, United States
Capital Health Medical Center-Hopewell, Pennington, New Jersey, United States
Valley Health System Ridgewood Campus, Ridgewood, New Jersey, United States
Lovelace Medical Center-Saint Joseph Square, Albuquerque, New Mexico, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Lovelace Radiation Oncology, Albuquerque, New Mexico, United States
Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Pluta Cancer Center, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
Mission Hospital, Asheville, North Carolina, United States
Hope Women's Cancer Centers-Asheville, Asheville, North Carolina, United States
CaroMont Regional Medical Center, Gastonia, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
UH Seidman Cancer Center at UH Avon Health Center, Avon, Ohio, United States
UHHS-Chagrin Highlands Medical Center, Beachwood, Ohio, United States
Miami Valley Hospital South, Centerville, Ohio, United States
Geauga Hospital, Chardon, Ohio, United States
Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States
Bethesda North Hospital, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Miami Valley Hospital North, Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor, Ohio, United States
UH Seidman Cancer Center at Southwest General Hospital, Middleburg Heights, Ohio, United States
University Hospitals Parma Medical Center, Parma, Ohio, United States
University Hospitals Portage Medical Center, Ravenna, Ohio, United States
UH Seidman Cancer Center at Firelands Regional Medical Center, Sandusky, Ohio, United States
Springfield Regional Cancer Center, Springfield, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
University Hospitals Sharon Health Center, Wadsworth, Ohio, United States
UH Seidman Cancer Center at Saint John Medical Center, Westlake, Ohio, United States
UHHS-Westlake Medical Center, Westlake, Ohio, United States
Cancer Centers of Southwest Oklahoma Research, Lawton, Oklahoma, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City, Oklahoma City, Oklahoma, United States
Clackamas Radiation Oncology Center, Clackamas, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Carlisle Regional Cancer Center, Carlisle, Pennsylvania, United States
Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States
UPMC Hillman Cancer Center Erie, Erie, Pennsylvania, United States
UPMC Cancer Center at UPMC Horizon, Farrell, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus, Harrisburg, Pennsylvania, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion, Mechanicsburg, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital, Sayre, Pennsylvania, United States
UPMC Memorial, York, Pennsylvania, United States
Saint Joseph's/Candler - Bluffton Campus, Bluffton, South Carolina, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
University of Tennessee - Knoxville, Knoxville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, United States
The Don and Sybil Harrington Cancer Center, Amarillo, Texas, United States
MD Anderson in The Woodlands, Conroe, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
MD Anderson West Houston, Houston, Texas, United States
Doctor's Hospital of Laredo, Laredo, Texas, United States
MD Anderson League City, League City, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
Farmington Health Center, Farmington, Utah, United States
University of Utah Sugarhouse Health Center, Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
FHCC South Lake Union, Seattle, Washington, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
PeaceHealth Southwest Medical Center, Vancouver, Washington, United States
United Hospital Center, Bridgeport, West Virginia, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Mayo Clinic Health System-Eau Claire Clinic, Eau Claire, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Mayo Clinic Health System-Franciscan Healthcare, La Crosse, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States
Diagnostic and Treatment Center, Weston, Wisconsin, United States
Marshfield Medical Center - Weston, Weston, Wisconsin, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
San Juan Community Oncology Group, San Juan, , Puerto Rico
Centro Comprensivo de Cancer de UPR, San Juan, , Puerto Rico
Name: Reshma Jagsi
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR