← Back to Search

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

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

OlympiAD 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.Check my eligibility

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.See study design

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.

OlympiAD Trial 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...

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.

OlympiAD Trial Timeline

Screening ~ 3 weeks3 visits

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

Secondary outcome measures

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 outcome measures

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

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

OlympiAD 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

~2140

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,312 Total Patients Enrolled

59 Trials studying Breast Cancer

7,534 Patients Enrolled for Breast Cancer

AstraZenecaLead Sponsor

4,262 Previous Clinical Trials

288,594,940 Total Patients Enrolled

174 Trials studying Breast Cancer

1,246,339 Patients Enrolled for Breast Cancer

Myriad Genetic Laboratories, Inc.Industry Sponsor

31 Previous Clinical Trials

14,335 Total Patients Enrolled

2 Trials studying Breast Cancer

1,836 Patients Enrolled for Breast Cancer

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

Frequently Asked Questions

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

Are there still opportunities for people to participate in this research project?

"Unfortunately, this particular trial is not taking any more candidates at the moment. The original posting date was March 27th, 2014 and it was last edited on October 10th, 2022. Although this specific study might be full, there are 2579 other trials with open enrollment currently."

Answered by AI

What are the primary indications for Olaparib?

"Olaparib is an effective therapeutic intervention for patients with primary peritoneal cancer, malignant neoplasm of the ovary, and other diseases."

Answered by AI

Is this study being conducted in more than one place within city limits?

"At the moment, this trial is being conducted in 38 different locations. These sites are situated in cities such as Portland, Saint Louis and Columbus. Additionally, there are other centres located across 38 additional locations. If you enroll in this study, it would be best to choose a location near you to cut down on travel time commitments."

Answered by AI

How many people are the most that can be in this test at one time?

"Unfortunately, this particular study has already closed recruitment. Although, there are 2382 other trials for patients with the brca 1 gene mutation and 197 studies regarding Olaparib that are still looking for participants."

Answered by AI

Has a similar experiment been conducted before?

"2005 saw the beginning of research into Olaparib. A Phase 1 clinical trial, sponsored by AstraZeneca, was conducted with 98 patients. This resulted in Olaparib being approved as a drug and, presently, there are 197 active trials involving Olaparib across 1462 cities and 59 countries."

Answered by AI

If a patient is middle-aged, can they still participate in this experiment?

"For this particular study, only patients aged 18 to 99 can enroll. However, there are other clinical trials involving people outside of this age range. In fact, 75 different studies focus on children and 2489 research projects target seniors."

Answered by AI

How can I sign up for this opportunity to help test a new medical treatment?

"This oncology study is looking for 302 patients with a BRCA1 gene mutation who have also received prior treatment with an anthracycline and a taxane. Eligible participants must be between 18-99 years old and have an ECOG performance status of 0 or 1."

Answered by AI

If so, could you please tell me what sort of research has been conducted on Olaparib in the past?

"Olaparib was first studied in 2005 at a dedicated research site. Since then, there have been 64 completed clinical trials with 197 active studies as of now. Many of these investigations are based out of Portland, Oregon."

Answered by AI

What are the documented risks associated with Olaparib?

"Olaparib has been evaluated in multiple Phase 3 clinical trials, meaning that there is some data supporting its efficacy and multiple rounds of data supporting its safety. Our team at Power estimates the safety of Olaparib to be a 3 on a scale from 1 to 3."

Answered by AI

Recent research and studies

brcaJournal

Olaparib for Metastatic Breast Cancer in Patients with a Germline <i>brca</i> Mutation

Robson, Mark, Seock-Ah Im, Elżbieta Senkus, Binghe Xu, Susan M. Domchek, Norikazu Masuda, Suzette Delaloge, et al.. 2017. “Olaparib for Metastatic Breast Cancer in Patients with a Germline brca Mutation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1706450.

clinicaltrials.govStudy

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

2014. "Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02000622.

All > Metastatic Breast Cancer > Lynparza