Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

Running, not enrolling · Phase 2

Conditions studied: Breast Inflammatory Carcinoma

In brief

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.

Key facts

Study ID

NCT03598257

Run by

National Cancer Institute (NCI)

People needed

300

Starts

2019-01-18

Expected to finish

2027-06-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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.

Where it is running

• 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
• AdventHealth Porter — Denver, Colorado, United States
• Shaw Cancer Center — Edwards, Colorado, United States
• AdventHealth Littleton — Littleton, Colorado, United States
• AdventHealth Parker — Parker, Colorado, United States
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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