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PARP Inhibitor

Radiation Therapy + Olaparib for Breast Cancer

Phase 2

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Invasive Disease-Free Survival (IDFS)

Secondary outcome measures

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

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

Overall Survival

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 2

~1730

Olaparib

2007

Completed Phase 4

~2140

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,221 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Reshma JagsiPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03598257 — Phase 2

Breast Cancer Research Study Groups: Group I (olaparib, radiation therapy), Group II (radiation therapy)

Breast Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03598257 — Phase 2

Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03598257 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any pre-existing reports concerning Radiation Therapy?

"Presently, 188 active studies are researching Radiation Therapy with 27 trials in Phase 3. While the majority of these research projects occur in Houston, Texas, there exists 9250 centers examining this therapy."

Answered by AI

In what medical scenarios is Radiation Therapy commonly utilized?

"Radiation Therapy is a common course of treatment for advanced cancer. It can also be utilized to treat ovary malignancies, primary peritoneal cancer, auditory or visual hallucinations and bodily aches."

Answered by AI

Are new participants being enrolled in this experiment?

"Agreed. Evidence from the clinicaltrials.gov website indicates that this research is actively searching for participants, with 300 patients sought out of 100 sites since its inception on September 12th 2018."

Answered by AI

How many healthcare centers are administering this trial?

"This clinical trial is presently underway at 100 sites, with locations such as Farmington Hills, Spartanburg and Nampa included. It would be prudent to select the nearest site in order to reduce travelling requirements if you decide to participate."

Answered by AI

What is the current capacity for this clinical trial's participants?

"Indeed, the information available on clinicaltrials.gov demonstrates that this medical trial is currently enrolling participants. It was initially shared on September 12th 2018 and has had a recent update made to it in November 2022. This study requires 300 patients from 100 distinct sites for participation."

Answered by AI

Does this medical experiment mark a new breakthrough in the field?

"At present, there are 188 live investigations into the efficacy of Radiation Therapy in 1468 cities and 59 countries. This research first began back in 2005 with a Phase 1 clinical trial sponsored by AstraZeneca that included 98 participants. Since then, 169 trials have been successfully concluded."

Answered by AI

Has the FDA sanctioned Radiation Therapy for medical use?

"According to the evaluation by Power, Radiation Therapy received a rating of 2 on a scale from 1-3 since there is existing evidence indicating its safety but none confirming its efficacy."

Answered by AI

Recent research and studies

Molecular Cancer TherapeuticsJournal

PARP1 Inhibition Radiosensitizes Models of Inflammatory Breast Cancer to Ionizing Radiation

Michmerhuizen, Anna R., Andrea M. Pesch, Leah Moubadder, Benjamin C. Chandler, Kari Wilder-Romans, Meleah Cameron, Eric Olsen, et al.. 2019. “PARP1 Inhibition Radiosensitizes Models of Inflammatory Breast Cancer to Ionizing Radiation”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-19-0520.

clinicaltrials.govStudy

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

2019. "Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03598257.

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