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Olaparib for Breast Cancer (OlympiA Trial)

Phase 3

Waitlist Available

Led By Andrew Tutt, 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

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

OlympiA 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.Check my eligibility

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.See study design

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.

OlympiA Trial 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.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I am fully active or can carry out light work.

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I have completed surgery for my breast and underarm area.

OlympiA Trial 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

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

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 outcome measures

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

Hyperglycaemia

Aspartate aminotransferase increased

Dizziness

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

OlympiA 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

~2140

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Breast International GroupOTHER

33 Previous Clinical Trials

52,740 Total Patients Enrolled

15 Trials studying Breast Cancer

31,927 Patients Enrolled for Breast Cancer

NRG OncologyOTHER

231 Previous Clinical Trials

99,016 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

Media Library

Olaparib Clinical Trial Eligibility Overview. Trial Name: NCT02032823 — Phase 3

Breast Cancer Research Study Groups: Olaparib, Placebo

Breast Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT02032823 — Phase 3

Olaparib 2023 Treatment Timeline for Medical Study. Trial Name: NCT02032823 — Phase 3

Frequently Asked Questions

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

Are there any restrictions on who is able to take part in this research project?

"This study is open to 1836 participants with breast cancer. Candidates must meet the following criteria: Triple negative breast cancer as defined by: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy), ER and/or PgR positive, HER2 negative, Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)., Completed adequate breast and axilla surgery., Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy"

Answered by AI

How many research subjects are participating in this trial?

"Unfortunately, this clinical trial is not currently recruiting patients for participation. However, there are 2677 other trials for breast cancer and 193 for Olaparib that are."

Answered by AI

Does this study have any open enrollment for new participants?

"Sorry, but you won't be able to participate in this clinical trial at the moment. The study was last updated on 8/29/2022, though it's possible that it will begin recruiting again in the future. There are currently 2677 trials for breast cancer and 193 for Olaparib that are actively enrolling participants."

Answered by AI

How many hospitals are managing this clinical trial?

"There are 100 recruiting sites for this study, which are situated in cities like Daytona Beach, Trumbull and Anchorage among others. If you are interested in participating, please choose the location closest to you to reduce the amount of travelling required."

Answered by AI

What is Olaparib's main therapeutic purpose?

"Olaparib is frequently used to treat patients with terminal cancer. However, it can also be used as a palliative care measure for patients with ovarian cancer, primary peritoneal cancer, and cancer-induced hallucinations."

Answered by AI

What are some other ways that Olaparib has been studied in the past?

"Olaparib was first researched in 2005. Since then, there have been 18,301 completed trials with olaparib. Right now, there are 193 different trials that are actively recruiting patients. Many of these trials are being conducted in Daytona Beach, Florida."

Answered by AI

Has Olaparib been cleared by the FDA?

"Olaparib has been through multiple rounds of clinical trials, meaning there is data supporting its efficacy and safety. Our team at Power gives it a rating of 3."

Answered by AI