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Immunotherapy

Olaparib + Durvalumab for Breast Cancer (OlympiaN Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or Females ≥18 years
Minimum body weight of 30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 3 years
Awards & highlights
No Placebo-Only Group

OlympiaN Trial Summary

This trialexplores a new drug combination to treat breast cancer. Olaparib and durvalumab being tested to see if they can better treat and understand the disease.

Who is the study for?
This trial is for adults over 18 with newly diagnosed, operable breast cancer that's not spread and has specific characteristics including a BRCA1 or BRCA2 mutation. Participants must be able to use contraception, provide consent, have good organ function, weigh at least 30 kg, and have an ECOG status of 0 or 1. Exclusions include those with certain heart conditions, active hepatitis or autoimmune diseases, HIV unless well-controlled on therapy, prior breast cancer treatments or exposure to certain drugs.Check my eligibility
What is being tested?
The study tests Olaparib alone and in combination with Durvalumab in treating HER2 negative BRCA-mutated breast cancer. Olaparib is a PARP inhibitor approved for metastatic cases; Durvalumab is an immunotherapy approved for some lung cancers. Their combined use in breast cancer treatment remains experimental.See study design
What are the potential side effects?
Olaparib may cause nausea, vomiting, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Durvalumab can lead to immune system-related side effects like inflammation of organs (colitis), skin reactions (rash), hormonal gland issues (thyroid dysfunction) and infusion-related reactions.

OlympiaN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I weigh at least 30 kg.
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I am able to understand and sign the consent form.
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I am using effective birth control methods.
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I have a new diagnosis of operable breast cancer that has not spread.
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My tests show a harmful change in my BRCA1 or BRCA2 gene.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs and bone marrow are functioning well.
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I am willing to have a biopsy before starting the study treatment.

OlympiaN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 3 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
To evaluate the efficacy, measured by pCR (pathological complete response) rate, of olaparib monotherapy and olaparib plus durvalumab combination therapy, as assessed by central pathology review.
Secondary outcome measures
Body Temperature
Pulse rate (heart rate)
Combined Modality Therapy
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

OlympiaN Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
Cohort B will consist of a higher-risk population of participants with HER2-negative ER-negative or ER-low defined as having a tumour size of >20 mm but ≤50 mm and N0 (T2/N0), or having a tumour size of >1 mm but ≤20 mm and N1 (T1/N1).
Group II: Cohort AExperimental Treatment1 Intervention
Cohort A will consist of a lower-risk population of participants with HER2-negative ER-negative or ER-low defined as having a tumour size >5 mm and ≤20 mm and N0 (T1b-c/N0).

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,221 Previous Clinical Trials
289,742,386 Total Patients Enrolled
173 Trials studying Breast Cancer
1,246,989 Patients Enrolled for Breast Cancer
Anitra Fielding, MBChBStudy DirectorAstraZeneca

Media Library

Durvalumab (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05498155 — Phase 2
Breast Cancer Research Study Groups: Cohort A, Cohort B
Breast Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT05498155 — Phase 2
Durvalumab (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05498155 — Phase 2

Frequently Asked Questions

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

Could I potentially be a candidate for this research study?

"Eligibility requirements for this study include a diagnosis of breast cancer and being between 18-130 years old. So far, 80 people have been enrolled in the trial."

Answered by AI

What is the regulatory status of Cohort B?

"Cohort B's safety was given a score of 2 out of 3 because, at this stage in the clinical trial process, there is only data supporting its safety and no evidence yet of efficacy."

Answered by AI

If I am over 35, can I participate in this clinical trial?

"Out of the 3452 clinical trials registered, this one falls in the middle with an age limit of 18-130. There are 76 trials for patients under the age of 18 and 2600 for patients over 65."

Answered by AI

Are there still positions available for this clinical trial?

"According to the clinicaltrials.gov website, this particular trial is not looking for new patients at the moment. This study was originally posted on October 21st 2020 and was last updated on October 11th 2020. Although this research isn't recruiting right now, there are 2698 other trials that are actively searching for participants."

Answered by AI
~3 spots leftby Apr 2024