Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA)
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ClinicalTrials.gov Identifier: NCT02032823 |
Recruitment Status :
Active, not recruiting
First Posted : January 10, 2014
Last Update Posted : March 9, 2021
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | January 3, 2014 | ||||||||||||||
First Posted Date ICMJE | January 10, 2014 | ||||||||||||||
Last Update Posted Date | March 9, 2021 | ||||||||||||||
Actual Study Start Date ICMJE | April 22, 2014 | ||||||||||||||
Actual Primary Completion Date | March 27, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Invasive Disease Free Survival (IDFS) [ Time Frame: Up to 10 years ] Time from randomisation to date of first treatment failure that is loco-regional or distant recurrence or new cancer or death from any cause
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Original Primary Outcome Measures ICMJE |
Efficacy of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS). [ Time Frame: Patients will be followed for disease recurrence and new cancers for approximately 10 years following randomisation ] Recurrence assessments on a 3 monthly basis during the first 2 years and on a 6 monthly basis in year 3, 4, 5 and annually from year 6 to 10. MRI performed every 12 months beginning 6 months after randomization
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Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Safety and tolerability of olaparib [ Time Frame: 12 months of study treatment + 30 days after treatment discontinuation ] Assessment of Adverse Events (AE), physical examination, vital signs including blood pressure (BP), pulse, and laboratory findings including clinical chemistry and haematology
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Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer | ||||||||||||||
Official Title ICMJE | A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy | ||||||||||||||
Brief Summary | Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy | ||||||||||||||
Detailed Description | Patients will be randomised in 1:1 ratio to either olaparib or placebo. Randomisation will be stratified by Hormone receptor status (ER and/or PgR positive/HER2 negative versus TNBC), prior neoadjuvant versus adjuvant chemotherapy and prior platinum use for breast cancer. Randomised patients will receive study treatment for up to a maximum of 12 months. All patients will have safety assessments every 2 weeks during the first month, every 4 weeks for the following 5 months and 3 monthly for the remaining 6 months of study treatment plus 30 days after its discontinuation. Following randomisation, all patients will be assessed regularly for signs, symptoms and evidence of disease recurrence by taking medical history, physical examination and mammogram/breast MRI. Efficacy assessments will be performed on a 3 monthly basis during the first 2 years, followed by 6 monthly assessments for years 3, 4 and 5 and annually thereafter. All patients (except those with bilateral mastectomy) will have mammogram / breast MRI annually for 10 years beginning 6 months after randomisation. All randomised patients will have clinical assessment visits for 10 years following their randomisation into the study. Once a patient completes 10 years of clinical assessment they will enter the survival follow up phase of the trial which will continue until 10 years after the last patient is randomised. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||
Actual Enrollment ICMJE |
1836 | ||||||||||||||
Original Estimated Enrollment ICMJE |
1320 | ||||||||||||||
Estimated Study Completion Date ICMJE | November 27, 2028 | ||||||||||||||
Actual Primary Completion Date | March 27, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 130 Years (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Canada, China, France, Germany, Hungary, Iceland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT02032823 | ||||||||||||||
Other Study ID Numbers ICMJE | D081CC00006 NSABP B-55 ( Other Identifier: NSABP ) BIG 6-13 ( Other Identifier: Breast International Group ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||
IPD Sharing Statement ICMJE |
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Responsible Party | AstraZeneca | ||||||||||||||
Study Sponsor ICMJE | AstraZeneca | ||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | AstraZeneca | ||||||||||||||
Verification Date | March 2021 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |