← Back to Search

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
Select...
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.
Select...
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:
Select...
I have never been treated with a PARP inhibitor like olaparib.
Select...
My breast cancer has spread to other parts of my body.
Select...
I have stopped taking certain strong medications for the required time before starting the study.

Timeline

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 EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant 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
9%
Dizziness
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
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

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
101,258 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
~160 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top