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PARP Inhibitor

Olaparib for Metastatic Breast Cancer (OlympiAD Trial)

Phase 3
Waitlist Available
Led By Mark Robson, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious
Histologically or cytologically confirmed breast cancer with evidence of metastatic disease
Must not have
Patients with HER2 positive disease
Untreated and/or uncontrolled brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks until sep 2017 (final os dco), then every 3 months. assessed up to a maximum of 64 months.
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effectiveness and safety of olaparib to standard chemotherapy in treating breast cancer that has spread to other parts of the body and has a mutation in the BRCA1 or BRCA2 gene.

Who is the study for?
This trial is for metastatic breast cancer patients with a harmful BRCA1/2 gene mutation. They must have had prior treatments including an anthracycline and a taxane, possibly platinum, but not progressed on it. ER/PR positive patients should have tried endocrine therapy without success or been deemed unsuitable for it. No more than two chemotherapy lines for metastatic cancer are allowed, and they can't have untreated brain metastases or certain other cancers unless cured over 5 years ago.
What is being tested?
The study compares the effectiveness of Olaparib alone versus standard chemotherapy (capecitabine, vinorelbine, or eribulin) chosen by the physician in treating metastatic breast cancer with gBRCA mutations. It's an open-label phase III trial where participants are randomly assigned to either treatment group.
What are the potential side effects?
Olaparib may cause nausea, vomiting, fatigue, low blood cell counts increasing infection risk, and potential kidney or liver issues. Standard chemotherapies can lead to hair loss, diarrhea or constipation, nerve damage causing numbness or tingling in hands and feet.

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...
My breast cancer has spread and this was confirmed through testing.
Select...
I am fully active or can carry out light work.
Select...
I have been treated with anthracycline and taxane before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is HER2 positive.
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I have brain metastases that haven't been treated or controlled.
Select...
I am HIV positive.
Select...
I have been treated with a PARP inhibitor before.
Select...
I have had more than 2 chemotherapy treatments for my advanced breast cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until sep 2017 (final os dco), then every 3 months. assessed up to a maximum of 64 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until sep 2017 (final os dco), then every 3 months. assessed up to a maximum of 64 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
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Secondary study objectives
Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Overall Survival (OS)
+4 more
Other study objectives
Time to First Subsequent Cancer Therapy or Death (TFST)
Time to First Subsequent Cancer Therapy or Death (TFST) at Extended OS
Time to Second Subsequent Cancer Therapy or Death (TSST)
+1 more

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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OlaparibExperimental Treatment1 Intervention
Olaparib tablet 300mg bd po
Group II: Physician's choice chemotherapyActive Control1 Intervention
Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21
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?

Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,501 Total Patients Enrolled
AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,122,770 Total Patients Enrolled
Myriad Genetic Laboratories, Inc.Industry Sponsor
31 Previous Clinical Trials
14,336 Total Patients Enrolled
Mark Robson, MDPrincipal InvestigatorMemorial Sloan-Kettering Cancer Center, New York
9 Previous Clinical Trials
8,671 Total Patients Enrolled

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02000622 — Phase 3
Breast cancer Research Study Groups: Olaparib, Physician's choice chemotherapy
Breast cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT02000622 — Phase 3
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02000622 — Phase 3
~26 spots leftby Dec 2025
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