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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. (OlympiAD)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02000622
First Posted: December 4, 2013
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Myriad Genetic Laboratories, Inc.
Information provided by (Responsible Party):
AstraZeneca
November 18, 2013
December 4, 2013
August 23, 2017
March 27, 2014
December 9, 2016   (Final data collection date for primary outcome measure)
Progression Free Survival by BICR using RECIST 1.1. [ Time Frame: Assessed when approx 75% patients have experienced objective disease progression by RECIST. RECIST assessments performed at baseline, every 6 wks for the first 6 mths, then every 12 wks until progression. Data collection will last up to approx 7 years. ]
Efficacy of single agent olaparib vs physician's choice chemotherapy (capecitabine, vinorelbine or eribulin) by assessment of progression free survival (PFS) using blinded independent central review (BICR) data assessed by Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Same as current
Complete list of historical versions of study NCT02000622 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Assessed at time of PFS analysis and when approx 60% patients have died by any cause (on average 15 months after randomisation). Survival assessed every 8 weeks following objective disease progression. Data collection will last up to approx 7 years. ]
    Efficacy of single agent olaparib vs physician's choice chemotherapy (capecitabine, vinorelbine or eribulin) by assessment of overall survival (OS). This assessment is performed until the time of the final OS analysis (when approximately 60% patients have died).
  • Time from randomisation to second progression or death (PFS2). [ Time Frame: Assessed at time of PFS analysis and at final OS analysis. After first objective disease progression by RECIST, patients will then be assessed every 8 weeks for second progression. Data collection will last up to approx 7 years. ]
    Efficacy of single agent olaparib vs physician's choice chemotherapy (capecitabine, vinorelbine or eribulin) by assessment of time to second progression, defined as objective radiological or symptomatic progression, or death (PFS2). This assessment is performed until the time of the final OS analysis (when approximately 60% patients have died).
  • Objective Response Rate by BICR using RECIST 1.1 [ Time Frame: Assessed at time of PFS analysis. RECIST assessments are performed at baseline, every 6 weeks for the first 6 months, then every 12 weeks until objective disease progression. Data collection will last up to approx 7 years. ]
    Efficacy of single agent olaparib vs physician's choice chemotherapy (capecitabine, vinorelbine or eribulin) by assessment of objective response rate (ORR) using BICR data assessed by RECIST 1.1.
  • Adjusted mean change from baseline in global QoL score from the EORTC-QLQ-C30 questionnaire. [ Time Frame: EORTC QLQ-C30 questionnaires to be completed at baseline and every 6 weeks until disease progression. Study data collection is expected to last up to approximately 7 years. ]
    Assessment of the effect of olaparib on the Health-related Quality of Life (HRQoL) as measured by EORTC QLQ-C30 global QoL scale.
  • Safety and tolerability of olaparib by assessment of adverse events. [ Time Frame: Adverse events collected from informed consent until post treatment 30-day follow-up period. Study data collection is expected to last up to approximately 7 years. ]
    Assessment of adverse events (AEs), graded by CTCAE (v4.0).
  • Safety and tolerability of olaparib by assessment of physical examination. [ Time Frame: Physical examinations carried out at baseline and until study treatment discontinued and at the post treatment 30-day follow-up visit. Study data collection is expected to last up to approximately 7 years. ]
    Assessment of physical examination.
  • Safety and tolerability of olaparib by assessment of vital signs. [ Time Frame: Vital signs assessments collected at baseline and until study treatment discontinued and at the post treatment 30-day follow-up visit. Study data collection is expected to last up to approximately 7 years. ]
    Assessment of vital signs including blood pressure (BP), pulse and electrocardiogram (ECG).
  • Safety and tolerability of olaparib by assessment of laboratory parameters. [ Time Frame: Laboratory parameter assessments collected at baseline and until study treatment discontinued and at the post treatment 30-day follow-up visit. Study data collection is expected to last up to approximately 7 years. ]
    Assessment of laboratory parameters including clinical chemistry and haematology.
Same as current
Not Provided
Not Provided
 
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.
A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Cancer Metastatic
  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
  • Drug: Olaparib
    Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.
  • Drug: Physician's choice chemotherapy

    Investigators will declare one of the following regimens:

    • Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days
    • Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days
    • Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days
  • Experimental: Olaparib
    Olaparib tablet 300mg bd po
    Intervention: Drug: Olaparib
  • Active Comparator: Physician's choice chemotherapy
    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
    Intervention: Drug: Physician's choice chemotherapy
Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450. Epub 2017 Jun 4. Erratum in: N Engl J Med. 2017 Oct 26;377(17 ):1700.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
302
December 21, 2018
December 9, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.
  • Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
  • Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
  • ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
  • ECOG performance status 0-1.
  • Adequate bone marrow, kidney and liver function.

Exclusion Criteria:

  • Prior treatment with PARP inhibitor.
  • Patients with HER2 positive disease.
  • More than 2 prior lines of chemotherapy for metastatic breast cancer.
  • Untreated and/or uncontrolled brain metastases.
  • Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
  • Known HIV (Human Immunodeficiency Virus) infection.
  • Pregnant or breast-feeding women.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   China,   Czechia,   France,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Peru,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Czech Republic
 
NCT02000622
D0819C00003
2013-005137-20 ( EudraCT Number )
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Myriad Genetic Laboratories, Inc.
Principal Investigator: Mark Robson, MD Memorial Sloan-Kettering Cancer Center, New York
AstraZeneca
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP