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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
13mo left

Started Jan 2019

Longer than P75 for phase_2

Geographic Reach
3 countries

220 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2019Jun 2027

First Submitted

Initial submission to the registry

July 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 18, 2019

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

8.4 years

First QC Date

July 24, 2018

Last Update Submit

April 9, 2026

Conditions

Keywords

Inflammatory breast cancerOlaparibRadiation therapy

Outcome Measures

Primary Outcomes (1)

  • Invasive Disease-Free Survival (IDFS)

    Time from date of registration to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. Analysis will be on an intent-to-treat basis and will estimate the survival endpoints using the product-limit method of Kaplan-Meier and will compare the time-to-event distributions using log-rank test statistics. Hazard ratios will be calculated from Cox regression analyses. Effect modification by the stratification variables will be tested as interactions with treatment and separate hazard ratios with 95% confidence intervals by major subgroups will be displayed in a forest plot to examine for consistency of the treatment effect over these subgroups.

    Up to 8 years

Secondary Outcomes (3)

  • Locoregional Recurrence-Free Interval (Local Disease-Free Interval [LDFI])

    Up to 8 years

  • Distant Relapse-Free Survival (Distant Recurrence-Free Survival)

    Up to 8 years

  • Overall Survival

    Up to 8 years

Study Arms (2)

Group I (olaparib, radiation therapy)

EXPERIMENTAL

Patients receive olaparib PO BID the day before standard 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 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.

Procedure: Biospecimen CollectionDrug: OlaparibRadiation: Radiation TherapyOther: Survey Administration

Group II (radiation therapy)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen CollectionRadiation: Radiation TherapyOther: Survey Administration

Interventions

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Group I (olaparib, radiation therapy)Group II (radiation therapy)

Given PO

Also known as: AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281
Group I (olaparib, radiation therapy)

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Group I (olaparib, radiation therapy)Group II (radiation therapy)

Ancillary study

Group I (olaparib, radiation therapy)Group II (radiation therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have inflammatory breast cancer without distant metastases. All biomarker subtype groups (estrogen receptor \[ER\], progesterone receptor \[PR\], HER2) are eligible. Inflammatory disease will be defined per American Joint Committee on Cancer (AJCC) 8th edition with documentation by history/exam and pathology at the time of diagnosis.
  • All patients must have completed neoadjuvant chemotherapy prior to mastectomy. The chemotherapy regimen is at the discretion of the treating physician but it is recommended that it include at least 4 cycles of anthracycline and/or taxane-based therapy (plus targeted therapy for patients with HER2+ disease). Response to chemotherapy is not a criterion for eligibility (both complete responders and those with residual disease are eligible). Please note that although pathologic complete response (pCR) is not required or excluded, pCR status must be determined post-surgery prior to randomization.
  • All patients must have undergone modified radical mastectomy (with negative margins on ink) with pathologic nodal evaluation (from level I and II axillary lymph node dissection \[ALND\]) at least 3 weeks and no more than 12 weeks prior to randomization, unless they receive additional chemotherapy after mastectomy. Patients must not have gross residual tumor or positive microscopic margins after mastectomy.
  • Additional adjuvant chemotherapy after surgery is allowed at the discretion of the treating physician, either completed prior to randomization or planned for after completion of protocol treatment. If adjuvant chemotherapy is administered after mastectomy, the patient must be randomized at least 3 weeks but no more than 12 weeks after the last dose of adjuvant chemotherapy.
  • Patients must not have a history of radiation therapy to the ipsilateral chest wall and/or regional nodes. Prior radiation therapy to other body sites is allowed.
  • Patients must not be planning to receive any other investigational agents during radiation therapy. Prior therapy, including prior treatment with olaparib or other PARP inhibitor, is allowed.
  • Patients must not have a known hypersensitivity to olaparib or any of the excipients of the product.
  • Patients must not have unresolved or unstable grade 2 or greater toxicity (with the exception of alopecia) from prior administration of another investigational drug and/or prior anti-cancer treatment.
  • Patients must not be planning to receive strong or moderate CYP3A inhibitors or inducers while on olaparib treatment. Patients receiving strong or moderate CYP3A inhibitors must agree to discontinue use at least 2 weeks prior to receiving olaparib. Patients receiving strong or moderate CYP3A inducers must agree to discontinue use at least 5 weeks prior to receiving olaparib.
  • Patients must not be planning to receive live virus or live bacterial vaccines while receiving olaparib and during the 30 day follow up period
  • Patients must not be planning to receive any additional anti-cancer therapy (chemotherapy, endocrine therapy, immunotherapy, biological therapy or other novel agent) while receiving radiotherapy with or without study medication. If a patient is receiving concurrent anti-HER2 targeted therapies, they must not take these medications during the period of radiotherapy (with or without study drug) while enrolled on the study.
  • Patients must be \>= 18 years of age
  • Patients must have Zubrod performance status 0-2.
  • Absolute neutrophil count (ANC) \>= 1000/mm\^3 (within 28 days prior to registration)
  • Platelet count \>= 100,000/mm\^3 (within 28 days prior to registration)
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (220)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508, United States

Location

Anchorage Oncology Centre

Anchorage, Alaska, 99508, United States

Location

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

Location

Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, 85704, United States

Location

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

Location

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

Location

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States

Location

Epic Care Partners in Cancer Care

Emeryville, California, 94608, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Fremont - Rideout Cancer Center

Marysville, California, 95901, United States

Location

Desert Regional Medical Center

Palm Springs, California, 92262, United States

Location

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

Location

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, 93444, United States

Location

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

AdventHealth Porter

Denver, Colorado, 80210, United States

Location

Shaw Cancer Center

Edwards, Colorado, 81632, United States

Location

AdventHealth Littleton

Littleton, Colorado, 80122, United States

Location

AdventHealth Parker

Parker, Colorado, 80138, United States

Location

Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, 19973, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Sacred Heart Hospital

Pensacola, Florida, 32504, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

Location

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687, United States

Location

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush MD Anderson Cancer Center

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

IU Health West Hospital

Avon, Indiana, 46123, United States

Location

IU Health North Hospital

Carmel, Indiana, 46032, United States

Location

IU Health Central Indiana Cancer Centers-Fishers

Fishers, Indiana, 46037, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

Location

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States

Location

Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States

Location

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States

Location

Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States

Location

Chelsea Hospital

Chelsea, Michigan, 48118, United States

Location

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States

Location

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, 48336, United States

Location

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States

Location

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States

Location

Henry Ford Health Providence Novi Hospital

Novi, Michigan, 48374, United States

Location

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341, United States

Location

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States

Location

Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085, United States

Location

University of Michigan Health - West

Wyoming, Michigan, 49519, United States

Location

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

Location

Fairview Ridges Hospital

Burnsville, Minnesota, 55337, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Gulfport Memorial Hospital

Gulfport, Mississippi, 39502, United States

Location

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655, United States

Location

Baptist Memorial Hospital and Cancer Center-Desoto

Southhaven, Mississippi, 38671, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Saint Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

Mercy Hospital South

St Louis, Missouri, 63128, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Logan Health Medical Center

Kalispell, Montana, 59901, United States

Location

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, 68114, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, 07652, United States

Location

Capital Health Medical Center-Hopewell

Pennington, New Jersey, 08534, United States

Location

Valley Health System Ridgewood Campus

Ridgewood, New Jersey, 07450, United States

Location

Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Lovelace Radiation Oncology

Albuquerque, New Mexico, 87109, United States

Location

Memorial Medical Center-Las Cruces

Las Cruces, New Mexico, 88011, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Pluta Cancer Center

Rochester, New York, 14623, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Hope Women's Cancer Centers-Asheville

Asheville, North Carolina, 28816, United States

Location

CaroMont Regional Medical Center

Gastonia, North Carolina, 28054, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Altru Cancer Center

Grand Forks, North Dakota, 58201, United States

Location

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011, United States

Location

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States

Location

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

Location

Geauga Hospital

Chardon, Ohio, 44024, United States

Location

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

Location

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, 44130, United States

Location

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

Location

University Hospitals Portage Medical Center

Ravenna, Ohio, 44266, United States

Location

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

Springfield Regional Cancer Center

Springfield, Ohio, 45504, United States

Location

ProMedica Flower Hospital

Sylvania, Ohio, 43560, United States

Location

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606, United States

Location

Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

University Hospitals Sharon Health Center

Wadsworth, Ohio, 44281, United States

Location

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, 44145, United States

Location

UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, 17015, United States

Location

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States

Location

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States

Location

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, 16121, United States

Location

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601, United States

Location

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109, United States

Location

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050, United States

Location

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

UPMC Memorial

York, Pennsylvania, 17408, United States

Location

Saint Joseph's/Candler - Bluffton Campus

Bluffton, South Carolina, 29910, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134, United States

Location

University of Tennessee - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Baptist Memorial Hospital and Cancer Center-Memphis

Memphis, Tennessee, 38120, United States

Location

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson West Houston

Houston, Texas, 77079, United States

Location

Doctor's Hospital of Laredo

Laredo, Texas, 78041, United States

Location

MD Anderson League City

League City, Texas, 77573, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

Farmington Health Center

Farmington, Utah, 84025, United States

Location

University of Utah Sugarhouse Health Center

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States

Location

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664, United States

Location

United Hospital Center

Bridgeport, West Virginia, 26330, United States

Location

West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States

Location

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911, United States

Location

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States

Location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

Location

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States

Location

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017, United States

Location

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States

Location

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States

Location

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States

Location

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

Québec, Quebec, G1R 2J6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

San Juan Community Oncology Group

San Juan, 00917, Puerto Rico

Location

Centro Comprensivo de Cancer de UPR

San Juan, 00927, Puerto Rico

Location

Related Publications (1)

  • Michmerhuizen AR, Pesch AM, Moubadder L, Chandler BC, Wilder-Romans K, Cameron M, Olsen E, Thomas DG, Zhang A, Hirsh N, Ritter CL, Liu M, Nyati S, Pierce LJ, Jagsi R, Speers C. PARP1 Inhibition Radiosensitizes Models of Inflammatory Breast Cancer to Ionizing Radiation. Mol Cancer Ther. 2019 Nov;18(11):2063-2073. doi: 10.1158/1535-7163.MCT-19-0520. Epub 2019 Aug 14.

MeSH Terms

Conditions

Inflammatory Breast Neoplasms

Interventions

Specimen HandlingolaparibRadiotherapyRadiation

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesTherapeuticsPhysical Phenomena

Study Officials

  • Reshma Jagsi

    SWOG Cancer Research Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2018

First Posted

July 26, 2018

Study Start

January 18, 2019

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-03

Locations