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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
  Purpose
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.

Condition Intervention Phase
Breast Cancer Metastatic BRCA 1 Gene Mutation BRCA 2 Gene Mutation Drug: Olaparib Drug: Physician's choice chemotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 302
Actual Study Start Date: March 27, 2014
Estimated Study Completion Date: December 21, 2018
Primary Completion Date: December 9, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olaparib
Olaparib tablet 300mg bd po
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.
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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000622


  Hide Study Locations
Locations
United States, California
Research Site
San Diego, California, United States, 92123
Research Site
Santa Rosa, California, United States, 95403
Research Site
Whittier, California, United States, 90602
United States, Colorado
Research Site
Denver, Colorado, United States, 80204
United States, Connecticut
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New Haven, Connecticut, United States, 06510
United States, District of Columbia
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Washington, D.C., District of Columbia, United States, 20007
United States, Florida
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Jacksonville, Florida, United States, 32224
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Orlando, Florida, United States, 32804
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Plantation, Florida, United States, 33324
United States, Georgia
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Columbus, Georgia, United States, 31904
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Marietta, Georgia, United States, 30060
United States, Illinois
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Chicago, Illinois, United States, 60612
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Niles, Illinois, United States, 60714
United States, Kansas
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Wichita, Kansas, United States, 67214
United States, Louisiana
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Lafayette, Louisiana, United States, 70506
United States, Massachusetts
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Boston, Massachusetts, United States, 02114
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Boston, Massachusetts, United States, 02118
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Boston, Massachusetts, United States, 02215
United States, Michigan
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Detroit, Michigan, United States, 48201
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Grand Rapids, Michigan, United States, 49503
United States, Minnesota
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Rochester, Minnesota, United States, 55905
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Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
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Jackson, Mississippi, United States, 39202
United States, Missouri
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Columbia, Missouri, United States, 65212
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Saint Louis, Missouri, United States, 63131-2374
United States, New Hampshire
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Lebanon, New Hampshire, United States, 03756
United States, New York
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Commack, New York, United States, 11725
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Harrison, New York, United States, 10604
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New York, New York, United States, 10021
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New York, New York, United States, 10065
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Rockville Centre, New York, United States, 11788
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Syracuse, New York, United States, 13210
United States, Ohio
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Cincinnati, Ohio, United States, 45267
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Cleveland, Ohio, United States, 44106
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Cleveland, Ohio, United States, 44195
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Portland, Oregon, United States, 97213
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Philadelphia, Pennsylvania, United States, 19104
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Sayre, Pennsylvania, United States, 18840
United States, Tennessee
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Germantown, Tennessee, United States, 38138
United States, Texas
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Houston, Texas, United States, 77030
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Tyler, Texas, United States, 75701
United States, Vermont
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Burlington, Vermont, United States, 05401
Bulgaria
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Plovdiv, Bulgaria, 4000
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Plovdiv, Bulgaria, 4004
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1303
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Sofia, Bulgaria, 1330
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Sofia, Bulgaria, 1504
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Varna, Bulgaria, 9010
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Vratza, Bulgaria, 3000
China
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Beijing, China, 100006
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Beijing, China, 100021
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Beijing, China, 100142
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Changchun, China, 130061
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Changsha, China, 410003
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Chengdu, China, 610041
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Dalian, China, 116011
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Guangzhou, China, 510060
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Hangzhou, China, 310022
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Harbin, China, 150081
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Nanjing, China, 210009
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Shanghai, China, 200025
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Shanghai, China, 200032
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Shenyang, China, 110016
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Tianjin, China, 300060
Czechia
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Brno, Czechia, 656 53
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Olomouc, Czechia, 775 20
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Praha 2, Czechia, 128 08
France
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Caen Cedex, France, 14076
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Montpellier, France, 34298
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Rouen, France, 76038
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Strasbourg Cedex, France, 67085
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Villejuif, France, 94800
Hungary
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Budapest, Hungary, 1032
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Budapest, Hungary, 1083
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Budapest, Hungary, 1115
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Budapest, Hungary, 1122
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Budapest, Hungary, 1145
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Nyíregyháza, Hungary, 4400
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Veszprém, Hungary, 8200
Italy
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Bologna, Italy, 40138
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Roma, Italy, 00100
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Roma, Italy, 00168
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Rozzano, Italy, 20089
Japan
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Chuo-ku, Japan, 104-0045
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Chuo-ku, Japan, 104-8560
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Fukuoka-shi, Japan, 811-1395
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Kagoshima-shi, Japan, 892-0833
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Nagoya-shi, Japan, 464-8681
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Osaka-shi, Japan, 540-0006
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Sapporo-shi, Japan, 003-0804
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Shinagawa-ku, Japan, 142-8666
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Suita-shi, Japan, 565-0871
Korea, Republic of
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Cheongju-si, Korea, Republic of, 28644
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Daegu, Korea, Republic of, 41404
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Incheon, Korea, Republic of, 21565
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Seongnam-si, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 03722
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Seoul, Korea, Republic of, 06351
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Seoul, Korea, Republic of, 07985
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Seoul, Korea, Republic of, 110-744
Mexico
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Estado de México, Mexico, 50080
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Merida, Mexico, 97000
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Merida, Mexico, 97133
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Mexico, Mexico, 6760
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Mérida, Mexico, 97070
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San Juan del Rio, Mexico, 76800
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Cusco, Peru, CUSCO 01
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Lima, Peru, LIMA 01
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Lima, Peru, Lima 18
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Lima, Peru, LIMA 27
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Lima, Peru, LIMA 34
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Lima, Peru, LIMA 41
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San Borja, Peru, LIMA 41
Poland
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Elbląg, Poland, 82-300
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Gdańsk, Poland, 80-952
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Grzepnica, Poland, 72-003
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Tarnobrzeg, Poland, 39-400
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Warszawa, Poland, 01-748
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Warszawa, Poland, 03-291
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Łódź, Poland, 93-513
Romania
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Bucharest, Romania, 013811
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Bucuresti, Romania, 011171
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Bucuresti, Romania, 030171
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Cluj Napoca, Romania, 400015
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Cluj-Napoca, Romania, 400015
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Ivanovo, Russian Federation, 153040
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Moscow, Russian Federation, 115478
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Omsk, Russian Federation, 644013
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Saint Petersburg, Russian Federation, 191015
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Saint Petersburg, Russian Federation, 195271
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Saint Petersburg, Russian Federation, 197022
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Saransk, Russian Federation, 430005
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St-Petersburg, Russian Federation, 197758
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St.Petersburg, Russian Federation, 191104
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Yaroslavl, Russian Federation, 150040
Spain
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Barcelona, Spain, 08003
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Córdoba, Spain, 14004
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Granada, Spain, 18014
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Madrid, Spain, 28034
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Majadahonda, Spain, 28222
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Oviedo, Spain, 33011
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Sevilla, Spain, 41013
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Valencia, Spain, 46009
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Zaragoza, Spain, 50009
Switzerland
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Bern, Switzerland, CH-3010
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Lausanne, Switzerland, CH-1011
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Zürich, Switzerland, CH-8063
Taiwan
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Kaohsiung, Taiwan, 807
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Taichung, Taiwan, 407
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Taipei, Taiwan, 10048
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Taipei, Taiwan, 10449
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Taipei, Taiwan, 11217
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Taoyuan, Taiwan, 333
Turkey
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Adana, Turkey, 01130
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Ankara, Turkey, 06100
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Edirne, Turkey, 22030
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Gaziantep, Turkey, 27310
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Istanbul, Turkey, 34093
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Izmir, Turkey, 35100
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Kayseri, Turkey, 38039
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Konya, Turkey, 42080
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Mersin, Turkey, 33070
United Kingdom
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Aberdeen, United Kingdom, AB25 2ZN
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Colchester, United Kingdom, CO4 5JL
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Coventry, United Kingdom, CV2 2DX
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London, United Kingdom, W12 0NN
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Manchester, United Kingdom, M20 4BX
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Plymouth, United Kingdom, PL6 8DH.
Sponsors and Collaborators
AstraZeneca
Myriad Genetic Laboratories, Inc.
Investigators
Principal Investigator: Mark Robson, MD Memorial Sloan-Kettering Cancer Center, New York
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02000622     History of Changes
Other Study ID Numbers: D0819C00003
2013-005137-20 ( EudraCT Number )
First Submitted: November 18, 2013
First Posted: December 4, 2013
Last Update Posted: August 23, 2017
Last Verified: August 2017

Keywords provided by AstraZeneca:
Breast Cancer
Metastatic
Olaparib
BRCA
PARP inhibitor
HER2
chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents