A Study of the Experimental Combination of Radiation Therapy and Olaparib For Inflammatory Breast Cancer

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Inflammatory Breast Cancer, breast cancer, breast cancer treatment
Type: Drug study, Phase 2
Target:
10 Participants
Investigator:
Description
The purpose of this study is to test adding the study drug (olaparib) to standard treatment. The addition of olaparib to standard treatment may or may not prevent your cancer from returning.

This study will help study doctors learn if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients.

The drug olaparib is approved by the FDA for use in other cancers. Olaparib is not approved for inflammatory breast cancer and is considered experimental in this study.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

ELIGIBILITY CRITERIA

Each of the criteria in the following section must be met in order for a patient to be considered eligible for registration.

Disease Related Criteria

a. Patients must have inflammatory breast cancer without distant metastases. All biomarker subtype groups (ER, PR, HER2) are eligible. Inflammatory disease will be defined per AJCC 8th edition with documentation by history/exam and pathology at the time of diagnosis.

Prior/Concurrent Therapy Criteria

a. 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 postsurgery prior to randomization.

b. 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.

c. 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.

d. 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.

e. 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.

f. Patients must not have a known hypersensitivity to olaparib or any of the excipients of the product.

g. 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.

h. 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.

i. Patients must not be planning to receive live virus or live bacterial vaccines while receiving olaparib and during the 30 day follow up period.

j. 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.

Clinical/Laboratory Criteria

a. Patients must be ≥ 18 years of age.

b. Patients must have Zubrod Performance Status 0-2.

c. Patients must have adequate hematologic function as evidenced by all of the following within 28 days prior to registration:

  • Absolute Neutrophil Count (ANC) ≥1000/mm3

  • Platelet Count ≥ 100,000/mm3

  • Hemoglobin ≥ 9.0 g/dL (after transfusion if required)

d. 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.

e. Patients must have adequate hepatic function as evidenced by all of the following within 28 days prior to registration:

  • Total bilirubin ≤ 1.5 x ULN

  • SGOT ≤ 2.5 x ULN

  • SGPT ≤ 2.5 x ULN

  • Alkaline Phosphatase ≤ 2.5 x ULN *Patients with documented Gilbert's disease may have bilirubin up to 2.5 mg/dL.

f. 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.

g. 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).

h. 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.

i. Patients must not have active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.

j. 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

k. Patients must not have a history of a resting ECG indicating uncontrolled, potentially reversible cardiac conditions (such as unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances) or congenital long QCYP3T syndrome.

l. Patients must not have myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML

m. 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

n. 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.

o. Patients must not have had previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).

p. Patients must not have had whole blood transfusions in the last 120 days prior to randomization.

Specimen Submission

a. 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

Regulatory Criteria

a. 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.

b. 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.

Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will receive 6 weeks of study treatment. You will then be asked to come in for a follow-up visit 5 weeks after your last radiation treatment. After that, you will be seen about every 3 months for up to 3 years after you started taking part in this study or until your disease comes back. You will then be asked to come in for a follow-up visit every 6 months until up to 8 years.
Recruitment period
From Aug. 5, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Inflammatory Breast Carcinoma

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