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Spots Global Cancer Trial Database for Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Reshma Jagsi

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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