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RecruitingLast updated: 3 January 2024

OlympiaN: This phase II study is evaluating how safe and effective targeted therapy (olaparib) is alone, and in combination with immunotherapy (durvalumab) is as neoadjuvant therapy in people with BRCA mutations and early stage HER2-negative breast cancerA Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients With BRCA Mutations and Early Stage HER2-Negative Breast Cancer

Clinical summary

Summary

This study has two cohorts. Cohort A will consist of a lower-risk population, and Cohort B will consist of a higher-risk population.

Participants will be allocated to receive 300mg oral olaparib twice daily as monotherapy, or in combination with durvalumab 1500mg via intravenous infusion every 4 weeks for a minimum of 4 and maximum of six 28-day cycles before undergoing definitive surgery.

Each participant will undergo definitive surgery, preferably within 6 weeks after receiving the final dose of neoadjuvant olaparib therapy, followed by standard treatment (radiation therapy, systemic therapy as per institutional standards).

Participants who achieve pCR at surgery will be allowed to continue on treatment with olaparib in the adjuvant setting in lieu of standard adjuvant systemic therapy, per physician's choice. If the physician chooses adjuvant olaparib, then the total duration of olaparib therapy in the neoadjuvant and adjuvant setting should be 12 cycles.

Conditions

This trial is treating patients with HER2- breast cancer

Cancer

Breast Cancers Breast

Age

People18 - 130

Phase

II

Trial Acronym

OlympiaN

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific Title

A Phase II, Multicentre, Open-Label Study to Assess the Efficacy and Safety of Olaparib Monotherapy and Olaparib Plus Durvalumab Combination as Neoadjuvant Therapy in Patients With BRCA Mutations and Early Stage HER2-Negative Breast Cancer

Eligibility

Inclusion

  • Males or Females ≥18 years
  • Minimum body weight of 30 kg
  • Capable of giving signed informed consent.
  • Male and Female participants of childbearing potential must use effective methods of contraception
  • Histologically confirmed, newly diagnosed, primary, operable, nonmetastatic invasive breast cancer with the following characteristics:

    --ER-negative or ER-low defined as IHC nuclear staining ≤10%

  • HER2-negative (not eligible for anti-HER2 therapy) defined as:

    • IHC 0, 1+ without in situ hybridization OR
    • In situ hybridization non-amplified with ratio less than 2.0 OR
    • In situ hybridization average HER2 copy number < 6 signals/cells
  • Clinical TNM staging (per AJCC 8th Edition) as follows:

    • T1b (>5 mm but ≤10 mm), N0, no known metastases (M0 or MX); OR
    • T1c (>10 mm but ≤20 mm), N0, no known metastases (M0 or MX); OR
    • T1 (>1 mm but ≤20 mm), N1, no known metastases (M0 or MX); OR
    • T2 (>20 mm but ≤50 mm), N0, no known metastases (M0 or MX).).
  • Documented deleterious or suspected deleterious mutation in BRCA1 or BRCA2 from local BRCA testing using either a germline or tumour test.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Participants must have adequate organ and bone marrow function
  • Participant must be willing to undergo a baseline research biopsy prior to start of study treatment.
  • Participant must be willing to have any leftover tumour tissue/FFPE from the diagnostic biopsy submitted for research purposes, if available.

Exclusion

  • Any evidence of other diseases (such as severe or uncontrolled systemic diseases or active, uncontrolled infections, including but not limited to, uncontrolled ventricular arrhythmia, uncontrolled hypertension, recent [within 3 months] myocardial infarction, uncontrolled major seizure disorder, renal transplant, active bleeding diseases, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography scan
  • Refractory nausea and vomiting, chronic gastrointestinal disease likely to interfere with absorption of the study medication, inability to swallow the formulated product
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence
  • Participants with MDS or AML
  • For higher risk (Cohort B) participants only: Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis
  • Known active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody
  • Known to have tested positive for human immunodeficiency virus unless currently on effective anti-retroviral therapy with an undetectable viral load within 6 months
  • History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (Common Terminology Criteria for Adverse Events [CTCAE] Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
  • Participant must not have had any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation, or experimental therapy
  • For higher risk (Cohort B) participants only: Prior exposure to anti-PD1, anti-PD-L1, or anti-CTLA4 agents (ICIs); OR an agent directed to other co-inhibitory or co-stimulatory T-cell receptors
  • Any concurrent anticancer treatment
  • Major surgical procedure (excluding placement of vascular access, local surgery of isolated lesions, or diagnostic staging) within 2 weeks of the first dose of study intervention
  • For higher risk (Cohort B) participants only: Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
  • Concomitant use of:

    • Known strong cytochrome P450 (CYP3A) inhibitors or moderate CYP3A inhibitors within 2 weeks prior to first dose of study intervention
    • Known strong CYP3A inducers or moderate CYP3A inducers .The required washout period prior to starting study therapy is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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