Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Olaparib; Drug: Placebo

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 approximately 10 years after the last patient is randomised.

• Study Type: Interventional
• Enrollment (Actual): 1837
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Berazategui, Argentina, B1884BBF
    • Research Site
  • CABA, Argentina, C1426ANZ
    • Research Site
  • CABA, Argentina, C1113AAE
    • Research Site
  • Córdoba, Argentina, 5000
    • Research Site
  • Córdoba, Argentina, X5002AOQ
    • Research Site
  • La Rioja, Argentina, 5300
    • Research Site
  • Mendoza, Argentina, 5500
    • Research Site
  • Rosario, Argentina, S2000KZE
    • Research Site
  • San Miguel de Tucumán, Argentina, T4000IAK
    • Research Site
  • Santa Fe, Argentina, S3000FFU
    • Research Site
• Australia
  • Adelaide, Australia, 5000
    • Research Site
  • Auchenflower, Australia, 4066
    • Research Site
  • Concord, Australia, 2139
    • Research Site
  • Douglas, Australia, 4814
    • Research Site
  • Gosford, Australia, 2250
    • Research Site
  • Hobart, Australia, 7000
    • Research Site
  • Malvern, Australia, 3144
    • Research Site
  • Melbourne, Australia, 3000
    • Research Site
  • Nedlands, Australia, 6009
    • Research Site
  • Randwick, Australia, 2031
    • Research Site
  • South Brisbane, Australia, 4101
    • Research Site
  • Tamworth, Australia, 2340
    • Research Site
  • Tweed Heads, Australia, 2485
    • Research Site
  • Waratah, Australia, 2298
    • Research Site
  • Wendouree, Australia, 3355
    • Research Site
• Austria
  • Graz, Austria, 8036
    • Research Site
  • Innsbruck, Austria, 6020
    • Research Site
  • Leoben, Austria, 8700
    • Research Site
  • Linz, Austria, 4010
    • Research Site
  • Linz, Austria, 4020
    • Research Site
  • Rankweil, Austria, 6830
    • Research Site
  • Ried, Austria, 4910
    • Research Site
  • Salzburg, Austria, 5020
    • Research Site
  • Sankt Veit an der Glan, Austria, 9300
    • Research Site
  • Vienna, Austria, 1090
    • Research Site
  • Vienna, Austria, 1130
    • Research Site
  • Vienna, Austria, 1160
    • Research Site
  • Villach, Austria, 9500
    • Research Site
  • Vöcklabruck, Austria, 4840
    • Research Site
  • Weiz, Austria, 8160
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  • Wels, Austria, 4600
    • Research Site
• Belgium
  • Anderlecht, Belgium, 1070
    • Research Site
  • Brussels, Belgium, 1090
    • Research Site
  • Brussels, Belgium, 1200
    • Research Site
  • Brussels, Belgium, 1070
    • Research Site
  • Charleroi, Belgium, 6060
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • Kortrijk, Belgium, 8500
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  • Leuven, Belgium, 3000
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  • Liège, Belgium, 4000
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  • Namur, Belgium, 5000
    • Research Site
  • Ostend, Belgium, 8400
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• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
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  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
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  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
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  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
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    • Toronto, Ontario, Canada, M4N 3M5
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  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
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    • Montreal, Quebec, Canada, H3T 1E2
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    • Montreal, Quebec, Canada, H2W 1T8
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    • Québec, Quebec, Canada, G1S 4L8
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  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
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    • Saskatoon, Saskatchewan, Canada, S7N 4H4
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• China
  • Beijing, China, 100021
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  • Beijing, China, 100730
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  • Beijing, China, 100006
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  • Changchun, China, 130061
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  • Chengdu, China, 610041
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  • Fuzhou, China, 350001
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  • Guangzhou, China, 510100
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  • Hangzhou, China, 310022
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  • Hangzhou, China, 310003
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  • Harbin, China, 150081
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  • Jinan, China, 250117
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  • Nanjing, China, 210029
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  • Shanghai, China, 200032
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  • Shanghai, China, 200025
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  • Shijiazhuang, China, 050020
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  • Tianjin, China, 300060
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• France
  • Avignon, France, 84918
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  • Besançon, France, 25030
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  • Limoges, France, 87042
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  • Lyon, France, 69373
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  • Paris, France, 75010
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  • Toulouse, France, 31076
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  • Villejuif, France, 94805
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• Germany
  • Aachen, Germany, 52074
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  • Frankfurt am Main, Germany, 65929
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  • Freiburg im Breisgau, Germany, 79106
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  • Fulda, Germany, 36043
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  • Fürth, Germany, 90766
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  • Gera, Germany, 07548
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  • Gifhorn, Germany, 38518
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  • Halle, Germany, 06120
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  • Hamburg, Germany, 20246
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  • Hamelin, Germany, 31785
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  • Hanover, Germany, 30625
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  • Hanover, Germany, 30559
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  • Hildesheim, Germany, 31134
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  • Karlsruhe, Germany, 76135
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  • Kassel, Germany, 34117
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  • Koblenz Am Rhein, Germany, 56068
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  • Leipzig, Germany, 04103
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  • Mainz Am Rhein, Germany, 55131
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  • Mannheim, Germany, 68167
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  • Memmingen, Germany, 87700
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  • Mühlhausen, Germany, 99974
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  • Mühlheim An Der Ruhr, Germany, 45468
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  • München, Germany, 80337
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  • München, Germany, 81675
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  • München, Germany, 80634
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  • Münster, Germany, 48149
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  • Nordhausen, Germany, 99734
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  • Offenbach, Germany, 63069
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  • Onkologisch Hämatologische Sch, Germany, 28209
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  • Paderborn, Germany, 33098
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  • Ravensburg, Germany, 88212
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  • Recklinghausen, Germany, 45659
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  • Rostock, Germany, 18059
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  • Rotenburg (Wümme), Germany, 27356
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  • Saarbrücken, Germany, 66113
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  • Schweinfurt, Germany, 97421
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  • Stendal, Germany, 39576
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  • Tübingen, Germany, 72076
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  • Ulm, Germany, 89075
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  • Witten, Germany, 58452
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• Hungary
  • Budapest, Hungary, 1145
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  • Budapest, Hungary, 1122
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• Iceland
  • Reykjavik, Iceland, 101
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• Israel
  • Jerusalem, Israel, 91120
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  • Petah Tikva, Israel, 49100
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  • Ramat Gan, Israel, 5265601
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  • Tel Aviv, Israel, 6423906
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• Italy
  • Bergamo, Italy, 24127
    • Research Site
  • Bologna, Italy, 40138
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  • Bolzano, Italy, 39100
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  • Castellanza Varese, Italy, 21053
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  • Lecce, Italy, 73100
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  • Legnago, Italy, 37045
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  • Milan, Italy, 20141
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  • Milan, Italy, 20132
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  • Modena, Italy, 41124
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  • Naples, Italy, 80131
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  • Nehrar, Italy, 37024
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  • Padova, Italy, 35128
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  • Palermo, Italy, 90146
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  • Pavia, Italy, 27100
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  • Perugia, Italy, 6156
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  • Prato, Italy, 59100
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  • Rimini, Italy, 47923
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  • Saronno, Italy, 21047
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  • Varese, Italy, 21100
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  • Viterbo, Italy, 01100
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• Japan
  • Chiba, Japan, 260-8717
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  • Chūōku, Japan, 104-0045
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  • Chūōku, Japan, 104-8560
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  • Fukuoka, Japan, 811-1395
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  • Hidaka-shi, Japan, 350-1298
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  • Hiroshima, Japan, 730-8518
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  • Isehara-shi, Japan, 259-1193
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  • Kagoshima, Japan, 892-0833
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  • Kashiwa, Japan, 277-8577
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  • Kawasaki-shi, Japan, 216-8511
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  • Kyoto, Japan, 606-8507
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  • Kōtoku, Japan, 135-8550
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  • Matsuyama, Japan, 791-0280
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  • Morioka, Japan, 028-3695
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  • Nagoya, Japan, 464-8681
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  • Nagoya, Japan, 467-8602
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  • Nankoku-shi, Japan, 783-8505
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  • Niigata, Japan, 951-8566
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  • Osaka, Japan, 540-0006
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  • Osaka, Japan, 541-8567
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  • Ota-shi, Japan, 373-8550
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  • Sapporo, Japan, 003-0804
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  • Shinagawa-ku, Japan, 142-8666
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  • Shizuoka, Japan, 411-8777
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  • Suita, Japan, 565-0871
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• Netherlands
  • Amsterdam, Netherlands, 1066 CX
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  • Breda, Netherlands, 4819 EV
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  • Geleen, Netherlands, 6162 BG
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  • Leiden, Netherlands, 2333 ZA
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  • Maastricht, Netherlands, 6202 AZ
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  • Rotterdam, Netherlands, 3015 GD
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  • Zaandam, Netherlands, 1502 DV
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• Poland
  • Gdansk, Poland, 80-952
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  • Grzepnica, Poland, 72-003
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  • Lodz, Poland, 93-338
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  • Olsztyn, Poland, 10-228
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  • Poznan, Poland, 60-693
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  • Warsaw, Poland, 02-781
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  • Warsaw, Poland, 01-748
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• Portugal
  • Lisbon, Portugal, 1998-018
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  • Lisbon, Portugal, 1099-023
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  • Lisbon, Portugal, 1400-038
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  • Lisbon, Portugal, 1500-650
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  • Loures, Portugal, 2674-514
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  • Porto, Portugal, 4200-072
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• Puerto Rico
  • San Juan, Puerto Rico, 00936
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• South Korea
  • Daegu, South Korea, 41404
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  • Goyang-si, South Korea, 10408
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  • Incheon, South Korea, 21565
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  • Seongnam-si, South Korea, 13620
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  • Seoul, South Korea, 03080
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  • Seoul, South Korea, 03722
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  • Seoul, South Korea, 05505
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  • Seoul, South Korea, 06351
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  • Seoul, South Korea, 07985
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• Spain
  • A Coruña, Spain, 15006
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  • Badajoz, Spain, 06008
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  • Badalona, Spain, 08916
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  • Barcelona, Spain, 08035
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  • Barcelona, Spain, 08025
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  • Castellon, Spain, 12002
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  • Cáceres, Spain, 10003
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  • Córdoba, Spain, 14004
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  • Elche(Alicante), Spain, 03202
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  • Girona, Spain, 17007
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  • Jaén, Spain, 23007
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  • Madrid, Spain, 28040
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  • Madrid, Spain, 28033
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  • Sabadell(Barcelona), Spain, 08208
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  • Salamanca, Spain, 37007
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  • San Sebastián, Spain, 20014
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  • Seville, Spain, 41009
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  • Terrassa(Barcelona), Spain, 08227
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• Sweden
  • Gothenburg, Sweden, 413 45
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• Switzerland
  • Bern, Switzerland, 3010
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• Taiwan
  • Changhua, Taiwan, 50006
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• United Kingdom
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• United States
  • Alabama
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    • Daytona Beach, Florida, United States, 32114
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  • Hawaii
    • Honolulu, Hawaii, United States
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  • Idaho
    • Boise, Idaho, United States
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    • Coeur d'Alene, Idaho, United States, 83814
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    • Fruitland, Idaho, United States
      • Research Site
    • Meridian, Idaho, United States
      • Research Site
    • Nampa, Idaho, United States
      • Research Site
    • Post Falls, Idaho, United States, 83854
      • Research Site
    • Twin Falls, Idaho, United States
      • Research Site
  • Illinois
    • Centralia, Illinois, United States
      • Research Site
    • Chicago, Illinois, United States
      • Research Site
    • Chicago, Illinois, United States, 60611
      • Research Site
    • Chicago, Illinois, United States, 60608
      • Research Site
    • Chicago, Illinois, United States, 60625
      • Research Site
    • Decatur, Illinois, United States
      • Research Site
    • Effingham, Illinois, United States
      • Research Site
    • Elmhurst, Illinois, United States, 60126
      • Research Site
    • Evanston, Illinois, United States
      • Research Site
    • Glenview, Illinois, United States
      • Research Site
    • Highland Park, Illinois, United States
      • Research Site
    • Joliet, Illinois, United States, 60435
      • Research Site
    • Maywood, Illinois, United States
      • Research Site
    • Mount Vernon, Illinois, United States
      • Research Site
    • Peoria, Illinois, United States
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    • Rockford, Illinois, United States, 61114
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    • Warrenville, Illinois, United States
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  • Indiana
    • Elkhart, Indiana, United States
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    • Fort Wayne, Indiana, United States
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    • Fort Wayne, Indiana, United States, 46845
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    • Indianapolis, Indiana, United States, 46202
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    • Indianapolis, Indiana, United States
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    • Mishawaka, Indiana, United States
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    • Munster, Indiana, United States
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    • Munster, Indiana, United States, 46321
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    • Plymouth, Indiana, United States
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    • South Bend, Indiana, United States
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    • Westville, Indiana, United States
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  • Iowa
    • Ames, Iowa, United States
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    • Ames, Iowa, United States, 50010
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    • Bettendorf, Iowa, United States, 52722
      • Research Site
    • Cedar Rapids, Iowa, United States, 52403
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    • Davenport, Iowa, United States, 52803
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    • Davenport, Iowa, United States, 52807
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    • Iowa City, Iowa, United States, 52242
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    • Iowa City, Iowa, United States
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    • Mason City, Iowa, United States
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    • Mason City, Iowa, United States, 50401
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  • Kansas
    • Chanute, Kansas, United States
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    • El Dorado, Kansas, United States
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    • Fairway, Kansas, United States, 66205
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    • Garden City, Kansas, United States
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    • Hays, Kansas, United States
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    • Kansas City, Kansas, United States
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    • Kansas City, Kansas, United States, 66112
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    • Lawrence, Kansas, United States
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    • Newton, Kansas, United States
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    • Olathe, Kansas, United States
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    • Salina, Kansas, United States
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    • Winfield, Kansas, United States
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  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Research Site
    • Louisville, Kentucky, United States
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  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
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    • Covington, Louisiana, United States
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    • Houma, Louisiana, United States
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    • Kenner, Louisiana, United States, 70065
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    • Monroe, Louisiana, United States, 71202
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    • New Orleans, Louisiana, United States
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    • Shreveport, Louisiana, United States, 71103
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    • Shreveport, Louisiana, United States, 71105
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    • Slidell, Louisiana, United States, 70458
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  • Maine
    • Augusta, Maine, United States, 04330
      • Research Site
    • Bangor, Maine, United States
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    • Belfast, Maine, United States, 4915
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    • Biddeford, Maine, United States, 04005
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    • Portland, Maine, United States
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    • Rockport, Maine, United States
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    • Sanford, Maine, United States, 04073
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    • Scarborough, Maine, United States, 04074
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  • Maryland
    • Baltimore, Maryland, United States
      • Research Site
    • Baltimore, Maryland, United States, 21202
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    • Baltimore, Maryland, United States, 21287
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    • Bethesda, Maryland, United States, 20814
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    • Easton, Maryland, United States
      • Research Site
    • Frederick, Maryland, United States, 21701
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    • Frederick, Maryland, United States, 21702
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    • Frederick, Maryland, United States
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  • Massachusetts
    • Boston, Massachusetts, United States
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    • Pittsfield, Massachusetts, United States
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    • Springfield, Massachusetts, United States
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  • Michigan
    • Ann Arbor, Michigan, United States
      • Research Site
    • Detroit, Michigan, United States
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    • Flint, Michigan, United States
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    • Grand Rapids, Michigan, United States
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    • Jackson, Michigan, United States
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    • Kalamazoo, Michigan, United States
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    • Muskegon, Michigan, United States
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    • Pontiac, Michigan, United States, 48341
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    • Port Huron, Michigan, United States, 48060
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    • Royal Oak, Michigan, United States
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    • Royal Oak, Michigan, United States, 48073
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    • Saint Joseph, Michigan, United States
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    • Southfield, Michigan, United States
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    • Traverse City, Michigan, United States
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    • Troy, Michigan, United States
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    • Warren, Michigan, United States
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  • Minnesota
    • Bemidji, Minnesota, United States, 56601
      • Research Site
    • Burnsville, Minnesota, United States
      • Research Site
    • Duluth, Minnesota, United States
      • Research Site
    • Edina, Minnesota, United States
      • Research Site
    • Fridley, Minnesota, United States
      • Research Site
    • Mankato, Minnesota, United States, 56001
      • Research Site
    • Maple Grove, Minnesota, United States, 55369
      • Research Site
    • Maplewood, Minnesota, United States
      • Research Site
    • Minneapolis, Minnesota, United States
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    • Rochester, Minnesota, United States
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    • Saint Cloud, Minnesota, United States, 56303
      • Research Site
    • Saint Louis Park, Minnesota, United States
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    • Saint Paul, Minnesota, United States
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    • Shakopee, Minnesota, United States, 55379
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    • Waconia, Minnesota, United States
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    • Woodbury, Minnesota, United States
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  • Mississippi
    • Jackson, Mississippi, United States
      • Research Site
  • Missouri
    • Cape Girardeau, Missouri, United States
      • Research Site
    • Joplin, Missouri, United States
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    • Kansas City, Missouri, United States
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    • Lee's Summit, Missouri, United States
      • Research Site
    • Springfield, Missouri, United States, 65807
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    • Springfield, Missouri, United States
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    • St Louis, Missouri, United States
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    • St Louis, Missouri, United States, 63141
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    • St Louis, Missouri, United States, 63109
      • Research Site
  • Montana
    • Bozeman, Montana, United States, 59715
      • Research Site
    • Kalispell, Montana, United States, 59901
      • Research Site
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Research Site
    • Lincoln, Nebraska, United States, 68510
      • Research Site
    • Lincoln, Nebraska, United States, 68506
      • Research Site
    • Norfolk, Nebraska, United States, 68701
      • Research Site
    • Omaha, Nebraska, United States
      • Research Site
    • Omaha, Nebraska, United States, 68114
      • Research Site
    • Omaha, Nebraska, United States, 68124
      • Research Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Research Site
    • Manchester, New Hampshire, United States, 03102
      • Research Site
    • Nashua, New Hampshire, United States, 03063
      • Research Site
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Research Site
    • Hamilton, New Jersey, United States
      • Research Site
    • Morristown, New Jersey, United States, 07960
      • Research Site
    • Mount Holly, New Jersey, United States
      • Research Site
    • New Brunswick, New Jersey, United States
      • Research Site
    • Voorhees Township, New Jersey, United States
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Research Site
    • Albuquerque, New Mexico, United States, 87102
      • Research Site
  • New York
    • Brooklyn, New York, United States, 11215
      • Research Site
    • Charlotte, New York, United States
      • Research Site
    • East Syracuse, New York, United States
      • Research Site
    • New Hyde Park, New York, United States, 11042
      • Research Site
    • New York, New York, United States
      • Research Site
    • Rochester, New York, United States, 14642
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    • The Bronx, New York, United States
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    • White Plains, New York, United States, 10601
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  • North Carolina
    • Albemarle, North Carolina, United States, 28002
      • Research Site
    • Asheville, North Carolina, United States
      • Research Site
    • Charlotte, North Carolina, United States
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    • Clinton, North Carolina, United States
      • Research Site
    • Concord, North Carolina, United States
      • Research Site
    • Durham, North Carolina, United States
      • Research Site
    • Gastonia, North Carolina, United States
      • Research Site
    • Goldsboro, North Carolina, United States
      • Research Site
    • Greensboro, North Carolina, United States
      • Research Site
    • Hendersonville, North Carolina, United States, 28791
      • Research Site
    • Hendersonville, North Carolina, United States
      • Research Site
    • Jacksonville, North Carolina, United States
      • Research Site
    • Kinston, North Carolina, United States
      • Research Site
    • Pinehurst, North Carolina, United States
      • Research Site
    • Wilson, North Carolina, United States
      • Research Site
    • Winston-Salem, North Carolina, United States
      • Research Site
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Research Site
    • Grand Forks, North Dakota, United States, 58201
      • Research Site
    • Minot, North Dakota, United States
      • Research Site
  • Ohio
    • Akron, Ohio, United States
      • Research Site
    • Beachwood, Ohio, United States, 44122
      • Research Site
    • Canton, Ohio, United States, 44710
      • Research Site
    • Cleveland, Ohio, United States, 44195
      • Research Site
    • Cleveland, Ohio, United States, 44106
      • Research Site
    • Cleveland, Ohio, United States, 44130
      • Research Site
    • Columbus, Ohio, United States, 43215
      • Research Site
    • Columbus, Ohio, United States
      • Research Site
    • Dayton, Ohio, United States
      • Research Site
    • Dayton, Ohio, United States, 45429
      • Research Site
    • Elyria, Ohio, United States, 44035
      • Research Site
    • Englewood, Ohio, United States, 45415
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    • Findlay, Ohio, United States, 45840
      • Research Site
    • Maumee, Ohio, United States
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    • Oregon, Ohio, United States
      • Research Site
    • Parma, Ohio, United States, 44129
      • Research Site
    • Perrysburg, Ohio, United States, 43551
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    • Springfield, Ohio, United States, 45504
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    • Sylvania, Ohio, United States
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    • Toledo, Ohio, United States
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    • Zanesville, Ohio, United States, 43701
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
    • Tulsa, Oklahoma, United States
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  • Oregon
    • Portland, Oregon, United States
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  • Pennsylvania
    • Abington, Pennsylvania, United States
      • Research Site
    • Broomall, Pennsylvania, United States, 19008
      • Research Site
    • Bryn Mawr, Pennsylvania, United States
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    • Clairton, Pennsylvania, United States, 15025
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    • Danville, Pennsylvania, United States
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    • Drexel Hill, Pennsylvania, United States
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    • Ephrata, Pennsylvania, United States, 17522
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    • Gettysburg, Pennsylvania, United States, 17325
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    • Harrisburg, Pennsylvania, United States
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    • Hazleton, Pennsylvania, United States
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    • Hershey, Pennsylvania, United States
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    • Lebanon, Pennsylvania, United States, 17042
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    • Lewisburg, Pennsylvania, United States, 17837
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    • Media, Pennsylvania, United States
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    • Paoli, Pennsylvania, United States, 19301
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    • Paoli, Pennsylvania, United States
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    • Philadelphia, Pennsylvania, United States
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    • Phoenixville, Pennsylvania, United States
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    • Pittsburgh, Pennsylvania, United States
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    • Reading, Pennsylvania, United States, 19605
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    • State College, Pennsylvania, United States
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    • West Reading, Pennsylvania, United States
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    • West Reading, Pennsylvania, United States, 19611
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    • Wilkes-Barre, Pennsylvania, United States
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    • Williamsport, Pennsylvania, United States, 17701
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    • Williamsport, Pennsylvania, United States
      • Research Site
    • Wynnewood, Pennsylvania, United States, 19096
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    • York, Pennsylvania, United States
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  • South Carolina
    • Anderson, South Carolina, United States
      • Research Site
    • Charleston, South Carolina, United States
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    • Greenville, South Carolina, United States
      • Research Site
    • Greenwood, South Carolina, United States
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    • Greer, South Carolina, United States
      • Research Site
    • Seneca, South Carolina, United States
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    • Spartanburg, South Carolina, United States
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  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Research Site
    • Lubbock, Texas, United States
      • Research Site
    • Lubbock, Texas, United States, 79430
      • Research Site
    • Lubbock, Texas, United States, 79415
      • Research Site
    • Round Rock, Texas, United States, 78665
      • Research Site
    • Temple, Texas, United States
      • Research Site
  • Utah
    • American Fork, Utah, United States
      • Research Site
    • Murray, Utah, United States
      • Research Site
    • Ogden, Utah, United States, 84403
      • Research Site
    • Provo, Utah, United States
      • Research Site
    • St. George, Utah, United States
      • Research Site
  • Vermont
    • Berlin Corners, Vermont, United States
      • Research Site
    • Burlington, Vermont, United States
      • Research Site
  • Virginia
    • Annandale, Virginia, United States, 22003
      • Research Site
    • Fairfax, Virginia, United States
      • Research Site
    • Fredericksburg, Virginia, United States
      • Research Site
    • Lynchburg, Virginia, United States
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    • Mechanicsville, Virginia, United States, 23116
      • Research Site
    • Midlothian, Virginia, United States
      • Research Site
    • Richmond, Virginia, United States
      • Research Site
    • South Hill, Virginia, United States
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  • Washington
    • Centralia, Washington, United States, 98531
      • Research Site
    • Kennewick, Washington, United States, 99336
      • Research Site
    • Kirkland, Washington, United States, 98034
      • Research Site
    • Poulsbo, Washington, United States, 98370
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    • Seattle, Washington, United States
      • Research Site
    • Seattle, Washington, United States, 98109
      • Research Site
  • West Virginia
    • Charleston, West Virginia, United States
      • Research Site
    • Huntington, West Virginia, United States, 25701
      • Research Site
    • Morgantown, West Virginia, United States, 26506
      • Research Site
    • Parkersburg, West Virginia, United States, 26101
      • Research Site
  • Wisconsin
    • Burlington, Wisconsin, United States
      • Research Site
    • Chippewa Falls, Wisconsin, United States, 54729
      • Research Site
    • Eau Claire, Wisconsin, United States, 54701
      • Research Site
    • Elkhorn, Wisconsin, United States
      • Research Site
    • Fond du Lac, Wisconsin, United States, 54937
      • Research Site
    • Grafton, Wisconsin, United States
      • Research Site
    • Green Bay, Wisconsin, United States
      • Research Site
    • Green Bay, Wisconsin, United States, 54303
      • Research Site
    • Green Bay, Wisconsin, United States, 54311-6519
      • Research Site
    • Kenosha, Wisconsin, United States
      • Research Site
    • La Crosse, Wisconsin, United States, 54601
      • Research Site
    • Ladysmith, Wisconsin, United States, 54848
      • Research Site
    • Marinette, Wisconsin, United States, 54143
      • Research Site
    • Marshfield, Wisconsin, United States, 54449
      • Research Site
    • Menomonee Falls, Wisconsin, United States
      • Research Site
    • Milwaukee, Wisconsin, United States
      • Research Site
    • Minocqua, Wisconsin, United States, 54548
      • Research Site
    • Mukwonago, Wisconsin, United States
      • Research Site
    • Oconomowoc, Wisconsin, United States
      • Research Site
    • Rice Lake, Wisconsin, United States, 54868
      • Research Site
    • Stevens Point, Wisconsin, United States, 54482
      • Research Site
    • Summit, Wisconsin, United States
      • Research Site
    • Waukesha, Wisconsin, United States
      • Research Site
    • Wausau, Wisconsin, United States, 54401
      • Research Site
    • Wauwatosa, Wisconsin, United States
      • Research Site
    • West Allis, Wisconsin, United States
      • Research Site
    • Weston, Wisconsin, United States, 54476
      • Research Site
    • Wisconsin Rapids, Wisconsin, United States, 54494
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:

  1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)
  2. ER and/or PgR positive, HER2 negative
• Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
• Completed adequate breast and axilla surgery.
• Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.
• ECOG 0-1.

Exclusion criteria:

• Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.

• Patients with second primary malignancy. EXCEPTIONS are:

  1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma
  2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5 years prior to randomisation and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
• Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
• Evidence of metastatic breast cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olaparib; Olaparib tablets 300mg b.i.d. p.o.	Drug: Olaparib; Patients will be administred olaparib orally twice daily (b.i.d.) 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; Other Names: Lynparza
Placebo Comparator: Placebo; Placebo tablets b.i.d. p.o.	Drug: Placebo; Patients will be administred matching placebo. Two (2) 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease Free Survival (IDFS)	An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.	From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distant Disease Free Survival (DDFS)	A DDFS event is defined as documented evidence of first distant recurrence of breast cancer or death from any cause	From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Overall Survival (OS)	An OS event is defined as death by any cause.	From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy	Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% Confidence Interval (CI) are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.	6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy	Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.	6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy	Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6, 12, 18 and 24 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.	6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy	Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6, 12, 18 and 24 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.	6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer	Number of patients with contralateral invasive breast cancer, contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer. Analysis of contralateral breast cancers exclude patients with a bilateral mastectomy prior to randomisation. Analysis of new primary ovarian cancers excludes male patients and patients with a bilateral oophorectomy prior to randomisation. Analysis of new primary fallopian tube cancer excludes male patients and patients with a bilateral salpingectomy prior to randomisation. Analysis of new primary peritoneal cancers excludes male patients.	From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Merck Sharp & Dohme LLC; NRG Oncology; Breast International Group; Myriad Genetic Laboratories, Inc.; Frontier Science & Technology Research Foundation, Inc.; The Breast Adjuvant Study Team
• Investigators: Principal Investigator: Andrew Tutt, Doctor of Medicine, Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK; Principal Investigator: Judy Garber, Doctor of Medicine, Harvard Medical School, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute, Susan F. Smither Center for Women's Cancers, 450 Brookline Avenue, Boston; MA 02215, US; Principal Investigator: Charles Geyer, Doctor of Medicine, Virginia Commonwealth University Massey Cancer Center, McGlothlin Medical Education Center, Room 12-217, 1201 East Marshall St., PO Box 980070, Richmond, VA 23298-0070, USA

Publications and helpful links

General Publications

• Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.
• Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. doi: 10.1056/NEJMoa2105215. Epub 2021 Jun 3.
• Ganz PA, Bandos H, Spanic T, Friedman S, Muller V, Kuemmel S, Delaloge S, Brain E, Toi M, Yamauchi H, de Duenas EM, Armstrong A, Im SA, Song CG, Zheng H, Sarosiek T, Sharma P, Geng C, Fu P, Rhiem K, Frauchiger-Heuer H, Wimberger P, t'Kint de Roodenbeke D, Liao N, Goodwin A, Chakiba-Brugere C, Friedlander M, Lee KS, Giacchetti S, Takano T, Henao-Carrasco F, Virani S, Valdes-Albini F, Domchek SM, Bane C, McCarron EC, Mita M, Rossi G, Rastogi P, Fielding A, Gelber RD, Scheepers ED, Cameron D, Garber J, Geyer CE, Tutt ANJ. Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gBRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer. J Clin Oncol. 2024 Apr 10;42(11):1288-1300. doi: 10.1200/JCO.23.01214. Epub 2024 Feb 1.

Helpful Links

• <p>AstraZeneca Cancer Study Locator Service</p><p>Phone:</p><p>877 400 4656 Email: astrazeneca@emergingmed.com</p>
• Related Info
• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2014
• Primary Completion (Actual): March 27, 2020
• Study Completion (Estimated): May 28, 2029

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimated): January 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; HER2; Olaparib; Adjuvant; BRCA 1/2
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; olaparib
• Other Study ID Numbers: D081CC00006; NSABP B-55 (Other Identifier: NSABP); BIG 6-13 (Other Identifier: Breast International Group); 2013-003839-30 (EudraCT Number); 2024-511096-15-00 (Registry Identifier: Clinical Trail Information System (CTIS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP