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Olaparib for Breast Cancer (OlympiA Trial)

Phase 3

Waitlist Available

Led By Charles Geyer, Doctor of Medicine

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious

Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both

Must not have

Any previous treatment with a PARP inhibitor, including olaparib

Evidence of metastatic breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomisation to data cut off: 27 march 2020 (approximately 5 years 11 months)

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new drug for breast cancer patients who have a BRCA1/2 mutation and have completed chemotherapy.

Who is the study for?

This trial is for adults with high-risk HER2 negative breast cancer who have a BRCA1/2 mutation. They must have finished at least 6 cycles of certain chemotherapies and surgery, not be on strong CYP3A inhibitors or inducers, and can't have had prior treatment with PARP inhibitors like olaparib.

What is being tested?

The study tests Olaparib as an additional (adjuvant) therapy against a placebo in patients with specific genetic mutations after they've completed initial treatments for breast cancer. The goal is to see if Olaparib can prevent cancer from coming back.

What are the potential side effects?

Olaparib may cause side effects such as nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, and potential allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

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

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I have a harmful BRCA1 or BRCA2 gene mutation.

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I've completed 6 or more cycles of chemotherapy with anthracyclines, taxanes, or both.

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My breast cancer is invasive and not spread to other parts.

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My breast cancer is triple negative, not responding to common hormone or HER2 treatments.

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My cancer is positive for hormone receptors and negative for HER2.

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I am fully active or can carry out light work.

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I have completed surgery for my breast and underarm area.

Exclusion Criteria

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

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I have never been treated with a PARP inhibitor like olaparib.

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My breast cancer has spread to other parts of my body.

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I have stopped taking certain strong medications for the required time before starting the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomisation to data cut off: 27 march 2020 (approximately 5 years 11 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomisation to data cut off: 27 march 2020 (approximately 5 years 11 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomisation to data cut off: 27 march 2020 (approximately 5 years 11 months) 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

Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy

Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy

+4 more

Other study objectives

Safety and tolerability of olaparib

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195

49%

Nausea

47%

Fatigue

38%

Diarrhoea

29%

Abdominal pain

29%

Anaemia

28%

Constipation

27%

Decreased appetite

27%

Back pain

26%

Vomiting

21%

Arthralgia

19%

Pyrexia

18%

Asthenia

13%

Rash

13%

Nasopharyngitis

11%

Alanine aminotransferase increased

11%

Dyspnoea

10%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OlaparibExperimental Treatment1 Intervention

Olaparib tablets 300mg b.i.d. p.o.

Group II: PlaceboPlacebo Group1 Intervention

Placebo tablets b.i.d. p.o.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Breast International GroupOTHER

33 Previous Clinical Trials

52,736 Total Patients Enrolled

15 Trials studying Breast Cancer

31,927 Patients Enrolled for Breast Cancer

NRG OncologyOTHER

238 Previous Clinical Trials

101,254 Total Patients Enrolled

8 Trials studying Breast Cancer

9,802 Patients Enrolled for Breast Cancer

Myriad Genetic Laboratories, Inc.Industry Sponsor

31 Previous Clinical Trials

12,801 Total Patients Enrolled

1 Trials studying Breast Cancer

AstraZenecaLead Sponsor

4,411 Previous Clinical Trials

289,121,235 Total Patients Enrolled

176 Trials studying Breast Cancer

1,243,236 Patients Enrolled for Breast Cancer

Frontier Science & Technology Research Foundation, Inc.Industry Sponsor

7 Previous Clinical Trials

5,551 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

4,023 Previous Clinical Trials

5,186,548 Total Patients Enrolled

61 Trials studying Breast Cancer

5,873 Patients Enrolled for Breast Cancer

Br.E.A.S.T. -Data Center & Operational Office Institut Jules BordetUNKNOWN

Charles Geyer, Doctor of MedicinePrincipal InvestigatorVirginia Commonwealth University Massey Cancer Center, McGlothlin Medical Education Center, Room 12-217, 1201 East Marshall St., PO Box 980070, Richmond, VA 23298-0070, USA

Andrew Tutt, Doctor of MedicinePrincipal InvestigatorIntegrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK

Judy Garber, Doctor of MedicinePrincipal InvestigatorHarvard Medical School, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Susan F. Smither Center for Women's Cancers, 450 Brookline Avenue, Boston; MA 02215, US