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Radiation Therapy with or without Olaparib in Treating Patients with Inflammatory Breast Cancer

Trial Status: Active

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 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

Inclusion Criteria

  • 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) 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 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 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)
  • Hemoglobin >= 9.0 g/dL (after transfusion if required and within 28 days prior to registration)
  • Patients must have adequate renal function as evidenced by calculated creatinine clearance >= 51 mL/min by Cockcroft-Gault equation, within 28 days prior to registration.
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 28 days prior to registration) * Patients with documented Gilbert's disease may have bilirubin up to 2.5 mg/dL
  • Serum glutamic-oxaloacetic transaminase (SGOT) =< 2.5 x ULN (within 28 days prior to registration)
  • Serum glutamate pyruvate transaminase (SGPT) =< 2.5 x ULN (within 28 days prior to registration)
  • Alkaline phosphatase =< 2.5 x ULN (within 28 days prior to registration)
  • Patients must not have a history of other prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Female patients must be postmenopausal or have a negative urine or serum pregnancy test within 14 days prior to registration. Female patients of childbearing potential and male patients with partners of childbearing potential, who are sexually active, must agree to the use of two highly effective forms of contraception during protocol treatment (groups 1 and 2) and for 6 months following the last dose of olaparib (group 1).
  • Patients who are breastfeeding must agree to discontinue breastfeeding before receiving olaparib due to potential risk for adverse events in nursing infants secondary to treatment of the mother with olaparib.
  • Patients must not have active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
  • Patients must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Patients must not have a history of a resting electrocardiography (ECG) indicating uncontrolled, potentially reversible cardiac conditions (such as unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, Fridericia's formula corrected QT interval [QTcF] prolongation > 500 ms, electrolyte disturbances) or congenital long QCYP3T syndrome.
  • Patients must not have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
  • Patient must not have had major surgery within 2 weeks of starting study treatments and patients must have recovered from any effects of any major surgery.
  • Patients must not have a history of uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan.
  • Patients must not have had previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • Patients must not have had whole blood transfusions in the last 120 days prior to randomization.
  • Patients must be offered the opportunity to participate in specimen submission for banking. * Note: Germline and somatic BRCA status will be evaluated using patient specimens submitted as part of the correlative scientific studies and considered at the time of study analysis, but this information will not be used for patient selection or stratification.
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Alaska

Anchorage
Alaska Oncology and Hematology LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Associates in Radiation Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Anchorage Oncology Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Katmai Oncology Group
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871
Providence Alaska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 907-212-6871

Arizona

Tucson
University of Arizona Cancer Center-North Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-327-2873
University of Arizona Cancer Center-Orange Grove Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 520-694-8900

Arkansas

Jonesboro
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 870-936-7067

California

Emeryville
Epic Care Partners in Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 510-629-6682
Palo Alto
Palo Alto Medical Foundation Health Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089
Vallejo
Sutter Solano Medical Center / Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 415-209-2686

Colorado

Edwards
Shaw Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 970-569-7429

Delaware

Newark
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100
Seaford
Nanticoke Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100

Florida

Pensacola
Sacred Heart Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 850-416-4611

Georgia

Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704

Hawaii

Aiea
The Cancer Center of Hawaii-Pali Momi
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-678-9000
Honolulu
Hawaii Cancer Care Inc-POB II
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-524-6115
Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-545-8548
The Cancer Center of Hawaii-Liliha
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-547-6881

Illinois

Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Decatur
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532

Indiana

Avon
IU Health West Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Fishers
IU Health Central Indiana Cancer Centers-Fishers
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-356-2422
Indianapolis
IU Health Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632

Iowa

Ames
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Clive
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Des Moines
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-945-7552
Overland Park
University of Kansas Cancer Center-Overland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-945-7552
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-945-7552

Maine

Brewer
Lafayette Family Cancer Center-EMMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-987-3005

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-442-3324

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Brighton
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Canton
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Lansing
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Livonia
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Novi
Ascension Providence Hospitals - Novi
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332
Royal Oak
William Beaumont Hospital-Royal Oak
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695
Southfield
Ascension Providence Hospitals - Southfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-849-5332
Troy
William Beaumont Hospital - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 248-551-7695

Minnesota

Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Rochester
Mayo Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Mississippi

Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Chesterfield
Saint Luke's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-205-6936
Kansas City
The University of Kansas Cancer Center-North
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-945-7552
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-945-7552
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

Nebraska

Omaha
Nebraska Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-354-5144

New Mexico

Albuquerque
Lovelace Medical Center-Saint Joseph Square
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 505-272-0530
Lovelace Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-272-0530
University of New Mexico Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 505-925-0366

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Asheville
Hope Women's Cancer Centers-Asheville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 828-213-2539
Mission Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 828-213-2539
Gastonia
CaroMont Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 704-834-2810

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Springfield
Springfield Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-775-1350

Oklahoma

Lawton
Cancer Centers of Southwest Oklahoma Research
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-231-4440
Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Portland
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614

Pennsylvania

Chadds Ford
Christiana Care Health System-Concord Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450

South Carolina

Greenville
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066

South Dakota

Sioux Falls
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366

Texas

Amarillo
The Don and Sybil Harrington Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 806-212-1985
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-632-6789

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100

Wisconsin

Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
La Crosse
Mayo Clinic Health System-Franciscan Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Marshfield
Marshfield Medical Center-Marshfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Minocqua
Marshfield Clinic-Minocqua Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Rice Lake
Marshfield Medical Center-Rice Lake
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Marshfield Clinic Stevens Point Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Weston
Diagnostic and Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-799-3989

Saskatchewan

Regina
Allan Blair Cancer Centre
Status: ACTIVE
Contact: Site Public Contact
Phone: 306-766-2213

PRIMARY OBJECTIVES:

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 OBJECTIVES:

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 OBJECTIVES:

I. To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants 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. Participants undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unaccepted toxicity.

GROUP II: Participants undergo standard radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unaccepted toxicity.

After completion of study treatment, participants 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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
SWOG

Principal Investigator
Reshma Jagsi

  • Primary ID S1706
  • Secondary IDs NCI-2018-01519
  • Clinicaltrials.gov ID NCT03598257