Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer
Breast Inflammatory Carcinoma
About this trial
This is an interventional treatment trial for Breast Inflammatory Carcinoma focused on measuring Inflammatory breast cancer, Olaparib, Radiation therapy
Eligibility Criteria
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 [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)
- 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 female partners who are of childbearing potential or pregnant) who are sexually active, must agree to the use of two highly effective forms of contraception during protocol treatment and for 6 months following the last dose of olaparib. Note: The efficacy of hormonal contraceptives may be reduced if co-administered with olaparib. Male patients must agree not to donate sperm during protocol treatment and for 6 months after the last dose of olaparib.
- 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 (genetic testing) are planned for future correlative evaluation, in order to examine treatment and circulating tumor deoxyribonucleic acid (ctDNA) response as stratified by BRCA 1/2 mutational status. Since this is future planned correlative research, any mutational status results would not be returned to the patient or the treating physician. There is no Clinical Laboratory Improvement Act (CLIA)-certified clinical genetic testing being performed for patients as part of the S1706 study. A forthcoming revision or separate corelative sciences proposal would be submitted to and approved by National Cancer Institute (NCI) prior to conduct of any planned future translational medicine objectives.
- Patients who can complete the patient-reported outcomes (PRO) Quality of Life (QOL) and PRO-CTCAE questionnaires in English must be offered the opportunity to participate in the optional PRO substudy. Patients who are not able to complete questionnaires in English need not be offered the opportunity to participate.
- 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.
Sites / Locations
- Anchorage Associates in Radiation MedicineRecruiting
- Alaska Oncology and Hematology LLCRecruiting
- Anchorage Oncology CentreRecruiting
- Katmai Oncology GroupRecruiting
- Providence Alaska Medical CenterRecruiting
- University of Arizona Cancer Center-Orange Grove CampusRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroRecruiting
- Alta Bates Summit Medical Center-Herrick Campus
- Epic Care Partners in Cancer CareRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Desert Regional Medical CenterRecruiting
- Palo Alto Medical Foundation Health Care
- University of California Davis Comprehensive Cancer CenterRecruiting
- Mission Hope Medical Oncology - Santa MariaRecruiting
- Gene Upshaw Memorial Tahoe Forest Cancer CenterRecruiting
- Sutter Solano Medical Center/Cancer Center
- Penrose-Saint Francis HealthcareRecruiting
- Porter Adventist HospitalRecruiting
- Shaw Cancer CenterRecruiting
- Littleton Adventist HospitalRecruiting
- Parker Adventist HospitalRecruiting
- Beebe South Coastal Health CampusRecruiting
- Helen F Graham Cancer CenterRecruiting
- Beebe Health CampusRecruiting
- TidalHealth Nanticoke / Allen Cancer Center
- George Washington University Medical CenterRecruiting
- Mount Sinai Comprehensive Cancer Center at AventuraRecruiting
- Mount Sinai Medical CenterRecruiting
- Sacred Heart HospitalRecruiting
- Tampa General HospitalRecruiting
- Grady Health SystemRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Memorial Health University Medical CenterRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- The Cancer Center of Hawaii-Pali MomiRecruiting
- Hawaii Cancer Care Inc - Waterfront PlazaRecruiting
- Queen's Medical CenterRecruiting
- The Cancer Center of Hawaii-LilihaRecruiting
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Rush - Copley Medical CenterRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical Center
- University of Illinois
- Decatur Memorial HospitalRecruiting
- Crossroads Cancer CenterRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- IU Health West HospitalRecruiting
- IU Health North HospitalRecruiting
- IU Health Central Indiana Cancer Centers-FishersRecruiting
- Indiana University/Melvin and Bren Simon Cancer CenterRecruiting
- IU Health Methodist HospitalRecruiting
- McFarland Clinic - AmesRecruiting
- Mercy Cancer Center-West LakesRecruiting
- Iowa Methodist Medical CenterRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- Salina Regional Health CenterRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- Wesley Medical CenterRecruiting
- University Medical Center New OrleansRecruiting
- LSU Health Sciences Center at ShreveportRecruiting
- Lafayette Family Cancer Center-EMMCRecruiting
- Greater Baltimore Medical CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Saint Joseph Mercy CantonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Beaumont Hospital - DearbornRecruiting
- Beaumont Hospital - Farmington HillsRecruiting
- Spectrum Health at Butterworth CampusRecruiting
- West Michigan Cancer CenterRecruiting
- Sparrow HospitalRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- Ascension Providence Hospitals - NoviRecruiting
- 21st Century Oncology-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Ascension Providence Hospitals - SouthfieldRecruiting
- Munson Medical CenterRecruiting
- William Beaumont Hospital - TroyRecruiting
- University of Michigan Health - WestRecruiting
- Sanford Joe Lueken Cancer CenterRecruiting
- Fairview Ridges Hospital
- Fairview Southdale HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Mayo Clinic in RochesterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Gulfport Memorial HospitalRecruiting
- Baptist Memorial Hospital and Cancer Center-OxfordRecruiting
- Baptist Memorial Hospital and Cancer Center-DesotoRecruiting
- Saint Francis Medical CenterRecruiting
- Saint Luke's HospitalRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- Missouri Baptist Medical CenterRecruiting
- Mercy Hospital Saint LouisRecruiting
- Mercy Hospital SpringfieldRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Kalispell Regional Medical CenterRecruiting
- Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
- Nebraska Methodist HospitalRecruiting
- The Valley Hospital-Luckow Pavilion
- Capital Health Medical Center-HopewellRecruiting
- Valley Hospital
- Lovelace Medical Center-Saint Joseph SquareRecruiting
- University of New Mexico Cancer CenterRecruiting
- Lovelace Radiation OncologyRecruiting
- Memorial Medical Center - Las CrucesRecruiting
- Roswell Park Cancer InstituteRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- Pluta Cancer CenterRecruiting
- University of RochesterRecruiting
- Mission Hospital
- Hope Women's Cancer Centers-Asheville
- CaroMont Regional Medical CenterRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Altru Cancer Center
- UH Seidman Cancer Center at UH Avon Health CenterRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Miami Valley Hospital SouthRecruiting
- Geauga HospitalRecruiting
- Good Samaritan Hospital - CincinnatiRecruiting
- Case Western Reserve UniversityRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Miami Valley Hospital NorthRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- University Hospitals Parma Medical CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- UH Seidman Cancer Center at Firelands Regional Medical CenterRecruiting
- Springfield Regional Cancer Center
- ProMedica Flower HospitalRecruiting
- ProMedica Toledo Hospital/Russell J Ebeid Children's HospitalRecruiting
- Upper Valley Medical CenterRecruiting
- University Hospitals Sharon Health CenterRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- UHHS-Westlake Medical CenterRecruiting
- Cancer Centers of Southwest Oklahoma ResearchRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Clackamas Radiation Oncology CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Carlisle Regional Cancer CenterRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- Guthrie Medical Group PC-Robert Packer HospitalRecruiting
- UPMC MemorialRecruiting
- Saint Joseph's/Candler - Bluffton CampusRecruiting
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South CarolinaRecruiting
- Prisma Health Cancer Institute - FarisRecruiting
- Prisma Health Cancer Institute - EastsideRecruiting
- Prisma Health Cancer Institute - GreerRecruiting
- Gibbs Cancer Center-PelhamRecruiting
- Prisma Health Cancer Institute - SenecaRecruiting
- Spartanburg Medical CenterRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- University of Tennessee - KnoxvilleRecruiting
- Baptist Memorial Hospital and Cancer Center-MemphisRecruiting
- The Don and Sybil Harrington Cancer CenterRecruiting
- MD Anderson in The WoodlandsRecruiting
- M D Anderson Cancer CenterRecruiting
- MD Anderson West HoustonRecruiting
- Doctor's Hospital of LaredoRecruiting
- MD Anderson League CityRecruiting
- MD Anderson in Sugar LandRecruiting
- Farmington Health CenterRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- FHCC South Lake UnionRecruiting
- PeaceHealth Southwest Medical CenterRecruiting
- United Hospital CenterRecruiting
- West Virginia University HealthcareRecruiting
- ThedaCare Regional Cancer CenterRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Mayo Clinic Health System-Eau Claire ClinicRecruiting
- Gundersen Lutheran Medical CenterRecruiting
- Mayo Clinic Health System-Franciscan Healthcare
- Marshfield Medical Center-MarshfieldRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Diagnostic and Treatment CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Odette Cancer Centre- Sunnybrook Health Sciences CentreRecruiting
- Jewish General HospitalRecruiting
- Allan Blair Cancer CentreRecruiting
- San Juan Community Oncology GroupRecruiting
- Centro Comprensivo de Cancer de UPRRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Group I (olaparib, radiation therapy)
Group II (radiation therapy)
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.
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.