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PARP Inhibitor

Radiation Therapy + Olaparib for Breast Cancer

Phase 2

Waitlist Available

Led By Reshma Jagsi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients must be >= 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing radiation therapy with or without olaparib to see which is more effective in treating inflammatory breast cancer.

Who is the study for?

This trial is for adults with inflammatory breast cancer without distant metastases who have completed neoadjuvant chemotherapy and mastectomy. They must not have had prior radiation to the chest or certain drug treatments during the study, agree to contraception if of childbearing potential, and cannot be breastfeeding. Participants need proper organ function, no uncontrolled diseases or recent major surgeries, and can't be on strong CYP3A inhibitors/inducers.

What is being tested?

The trial is testing whether adding Olaparib (a PARP inhibitor that prevents cancer cells from repairing DNA damage) to standard radiation therapy improves outcomes in patients with inflammatory breast cancer compared to radiation alone. Patients are randomly assigned to one of these two treatment options.

What are the potential side effects?

Olaparib may cause nausea, vomiting, fatigue, anemia (low red blood cell counts), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), digestive issues like diarrhea or constipation, and increased risk of developing other cancers such as leukemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not planning to receive any other cancer treatments while on the study.

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I am 18 years old or older.

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I haven't had major surgery in the last 2 weeks and have recovered from any past surgeries.

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My inflammatory disease is confirmed by medical history, physical exams, and pathology reports.

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I finished chemotherapy before my breast removal surgery.

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I have not had a blood transfusion in the last 4 months.

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I have inflammatory breast cancer that has not spread to distant parts of my body.

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I have not had radiation therapy on the same side of my chest before.

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I am not planning to take strong or moderate drugs that affect olaparib.

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My kidney function is good, with a creatinine clearance rate of at least 51 mL/min.

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I agree to stop breastfeeding before starting olaparib treatment.

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I do not have any ongoing serious infections or heart problems.

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I can swallow pills and don't have stomach issues affecting medicine absorption.

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I do not have myelodysplastic syndrome or acute myeloid leukemia.

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I don't have recent severe heart issues, uncontrolled seizures, unstable spine problems, specific vein syndrome, or severe lung disease.

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I do not have any visible tumor or cancer cells at the edges of my mastectomy.

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My cancer is positive for ER, PR, or HER2.

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I have not had a bone marrow or cord blood transplant.

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I don't have serious heart conditions or abnormal heart rhythm issues.

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I can take care of myself and am up and about more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Invasive Disease-Free Survival (IDFS)

Secondary study objectives

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

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

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (olaparib, radiation therapy)Experimental Treatment4 Interventions

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.

Group II: Group II (radiation therapy)Active Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Olaparib

2007

Completed Phase 4

~2190