What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as Olaparib (a PARP inhibitor) and Durvalumab (an immunotherapy), have distinct side effect profiles. Olaparib is associated with nausea, fatigue, vomiting, and anemia. Durvalumab can cause immune-related adverse events, including skin reactions, colitis, hepatitis, endocrinopathies, and pneumonitis. Patients undergoing these treatments should discuss potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Olaparib, a PARP inhibitor, has been approved by the FDA for treating women with BRCA-mutated, HER2-negative metastatic breast cancer. This approval is based on its ability to target cancer cells deficient in DNA repair mechanisms. Durvalumab, an immunotherapy drug, is approved for treating patients with locally advanced non-small cell lung cancer and extensive-stage small cell lung cancer, but it is still under investigation for breast cancer treatment. These drugs represent targeted and immune-based approaches in cancer therapy, focusing on exploiting specific vulnerabilities in cancer cells and enhancing the body's immune response against them.

What other types of research exist?

Promising novel alternatives to Olaparib and Durvalumab for breast cancer patients include: 1) Niraparib, another PARP inhibitor showing efficacy in ovarian and breast cancers. 2) Pembrolizumab, an immunotherapy approved for various cancers, including breast cancer with specific biomarkers. 3) Combination therapies such as Abiraterone plus Olaparib, which have shown promising results in clinical trials for cancers with homologous recombination repair deficiencies. 4) Antibody-drug conjugates like Trastuzumab Deruxtecan, which target HER2-positive breast cancer cells. These alternatives offer new avenues for treatment and may be considered based on individual patient profiles and genetic markers.

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Immunotherapy

Olaparib + Durvalumab for Breast Cancer (OlympiaN Trial)

Phase 2

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Documented deleterious or suspected deleterious mutation in BRCA1 or BRCA2 from local BRCA testing

Must not have

Major surgical procedure within 2 weeks of the first dose of study intervention

Participant must not have had any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation, or experimental therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approx. 3 years

Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My tests show a harmful change in my BRCA1 or BRCA2 gene.

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I have a new diagnosis of operable breast cancer that has not spread.

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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.

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I weigh at least 30 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery in the last 2 weeks.

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I have not received any treatment for my current breast cancer.

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I am not taking any strong or moderate drugs that affect liver enzymes.

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I have a history of irregular heartbeats or uncontrolled heart rhythm problems.

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I have or had an autoimmune or inflammatory disorder.

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I have been diagnosed with MDS or AML.

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I have been treated with specific medications before.

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I am not on any cancer treatments right now.

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I haven't taken strong or moderate CYP3A inhibitors in the last 2 weeks.

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I do not have severe diseases or uncontrolled infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approx. 3 years

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

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).

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

PARP inhibitors, such as Olaparib, work by blocking the PARP enzyme, which is crucial for repairing DNA damage in cells. This is particularly effective in cancer cells with BRCA mutations, as these cells already have compromised DNA repair mechanisms, leading to cell death. Immunotherapy, like Durvalumab, enhances the body's immune response against cancer cells by blocking the PD-L1 protein, which normally helps cancer cells evade immune detection. These treatments are significant for breast cancer patients as they offer targeted approaches that can improve outcomes, especially in cases where traditional therapies may be less effective.

The safety of antiangiogenic agents and PARP inhibitors in platinum-sensitive recurrent ovarian cancer.