AzTrials
AzTrials

Breast CancerPhase 3OlympiANCT02032823

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

A Phase 3 study testing Olaparib in people with Breast Cancer, run by AstraZeneca at 698 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Breast Cancer
What is being tested?
Olaparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,837 participants
Where
698 sitesin 24 countries
Study dates
22 Apr 2014to 28 May 2029
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:
  • Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)
  • 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.

Who cannot join

  • 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:
  • 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
  • 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

Trial locations and contacts

698 sites in 24 countries.

630 sites in 24 countries

United States300 sites

  • Research Site

    ‘Aiea, Hawaii

  • Research Site

    Abington, Pennsylvania

  • Research Site

    Akron, Ohio

  • Research Site

    Albemarle, North Carolina, 28002

  • Research Site

    Albuquerque, New Mexico, 87102

  • Research Site

    Albuquerque, New Mexico

  • Research Site

    American Fork, Utah

  • Research Site

    Ames, Iowa, 50010

  • Research Site

    Ames, Iowa

  • Research Site

    Anchorage, Alabama, 99508

  • Research Site

    Anchorage, Alaska, 99508

  • Research Site

    Anderson, South Carolina

  • Research Site

    Ann Arbor, Michigan

  • Research Site

    Annandale, Virginia, 22003

  • Research Site

    Asheville, North Carolina

  • Research Site

    Atlanta, Georgia, 30322

  • Research Site

    Augusta, Maine, 04330

  • Research Site

    Aurora, Colorado, 80045

  • Research Site

    Baldwin Park, California

  • Research Site

    Baltimore, Maryland, 21202

  • Research Site

    Baltimore, Maryland, 21287

  • Research Site

    Baltimore, Maryland

  • Research Site

    Bangor, Maine

  • Research Site

    Baton Rouge, Louisiana, 70809

  • Research Site

    Baton Rouge, Louisiana

  • Research Site

    Beachwood, Ohio, 44122

  • Research Site

    Belfast, Maine, 4915

  • Research Site

    Bemidji, Minnesota, 56601

  • Research Site

    Berkeley, California, 94704

  • Research Site

    Berlin Corners, Vermont

  • Research Site

    Bethesda, Maryland, 20814

  • Research Site

    Bettendorf, Iowa, 52722

  • Research Site

    Biddeford, Maine, 04005

  • Research Site

    Boise, Idaho

  • Research Site

    Boston, Massachusetts

  • Research Site

    Bozeman, Montana, 59715

  • Research Site

    Brooklyn, New York, 11215

  • Research Site

    Broomall, Pennsylvania, 19008

  • Research Site

    Bryn Mawr, Pennsylvania

  • Research Site

    Burlington, Vermont

  • Research Site

    Burlington, Wisconsin

  • Research Site

    Burnsville, Minnesota

  • Research Site

    Canton, Ohio, 44710

  • Research Site

    Cape Girardeau, Missouri

  • Research Site

    Cedar Rapids, Iowa, 52403

  • Research Site

    Centralia, Illinois

  • Research Site

    Centralia, Washington, 98531

  • Research Site

    Chanute, Kansas

  • Research Site

    Charleston, South Carolina

  • Research Site

    Charleston, West Virginia

  • Research Site

    Charlotte, New York

  • Research Site

    Charlotte, North Carolina

  • Research Site

    Chicago, Illinois, 60608

  • Research Site

    Chicago, Illinois, 60611

  • Research Site

    Chicago, Illinois, 60625

  • Research Site

    Chicago, Illinois

  • Research Site

    Chippewa Falls, Wisconsin, 54729

  • Research Site

    Clairton, Pennsylvania, 15025

  • Research Site

    Cleveland, Ohio, 44106

  • Research Site

    Cleveland, Ohio, 44130

  • Research Site

    Cleveland, Ohio, 44195

  • Research Site

    Clinton, North Carolina

  • Research Site

    Coeur d'Alene, Idaho, 83814

  • Research Site

    Colorado Springs, Colorado, 80907

  • Research Site

    Columbus, Georgia, 31904

  • Research Site

    Columbus, Ohio, 43215

  • Research Site

    Columbus, Ohio

  • Research Site

    Concord, North Carolina

  • Research Site

    Covington, Louisiana

  • Research Site

    Danville, Pennsylvania

  • Research Site

    Davenport, Iowa, 52803

  • Research Site

    Davenport, Iowa, 52807

  • Research Site

    Dayton, Ohio, 45429

  • Research Site

    Dayton, Ohio

  • Research Site

    Daytona Beach, Florida, 32114

  • Research Site

    Decatur, Georgia

  • Research Site

    Decatur, Illinois

  • Research Site

    Deerfield Beach, Florida

  • Research Site

    Denver, Colorado, 80205

  • Research Site

    Derby, Connecticut

  • Research Site

    Detroit, Michigan

  • Research Site

    Drexel Hill, Pennsylvania

  • Research Site

    Duarte, California, 91010

  • Research Site

    Duluth, Minnesota

  • Research Site

    Durham, North Carolina

  • Research Site

    East Syracuse, New York

  • Research Site

    Easton, Maryland

  • Research Site

    Eau Claire, Wisconsin, 54701

  • Research Site

    Edina, Minnesota

  • Research Site

    Edwards, Colorado

  • Research Site

    Effingham, Illinois

  • Research Site

    El Dorado, Kansas

  • Research Site

    Elkhart, Indiana

  • Research Site

    Elkhorn, Wisconsin

  • Research Site

    Elmhurst, Illinois, 60126

  • Research Site

    Elyria, Ohio, 44035

  • Research Site

    Englewood, Ohio, 45415

  • Research Site

    Ephrata, Pennsylvania, 17522

  • Research Site

    Evanston, Illinois

  • Research Site

    Fairfax, Virginia

  • Research Site

    Fairfield, Connecticut

  • Research Site

    Fairway, Kansas, 66205

  • Research Site

    Fargo, North Dakota, 58102

  • Research Site

    Findlay, Ohio, 45840

  • Research Site

    Flemington, New Jersey, 08822

  • Research Site

    Flint, Michigan

  • Research Site

    Fond du Lac, Wisconsin, 54937

  • Research Site

    Fontana, California, 92335

  • Research Site

    Fort Collins, Colorado

  • Research Site

    Fort Smith, Arkansas

  • Research Site

    Fort Wayne, Indiana, 46845

  • Research Site

    Fort Wayne, Indiana

  • Research Site

    Frederick, Maryland, 21701

  • Research Site

    Frederick, Maryland, 21702

  • Research Site

    Frederick, Maryland

  • Research Site

    Fredericksburg, Virginia

  • Research Site

    Fresno, California

  • Research Site

    Fridley, Minnesota

  • Research Site

    Fruitland, Idaho

  • Research Site

    Gainesville, Florida

  • Research Site

    Garden City, Kansas

  • Research Site

    Gastonia, North Carolina

  • Research Site

    Gettysburg, Pennsylvania, 17325

  • Research Site

    Gilbert, Arizona, 85234

  • Research Site

    Glenview, Illinois

  • Research Site

    Goldsboro, North Carolina

  • Research Site

    Grafton, Wisconsin

  • Research Site

    Grand Forks, North Dakota, 58201

  • Research Site

    Grand Island, Nebraska, 68803

  • Research Site

    Grand Rapids, Michigan

  • Research Site

    Green Bay, Wisconsin, 54303

  • Research Site

    Green Bay, Wisconsin, 54311-6519

  • Research Site

    Green Bay, Wisconsin

  • Research Site

    Greenbrae, California, 94904

  • Research Site

    Greensboro, North Carolina

  • Research Site

    Greenville, South Carolina

  • Research Site

    Greenwood, South Carolina

  • Research Site

    Greer, South Carolina

  • Research Site

    Guilford, Connecticut

  • Research Site

    Hamilton, New Jersey

  • Research Site

    Harrisburg, Pennsylvania

  • Research Site

    Hays, Kansas

  • Research Site

    Hazleton, Pennsylvania

  • Research Site

    Hendersonville, North Carolina, 28791

  • Research Site

    Hendersonville, North Carolina

  • Research Site

    Hershey, Pennsylvania

  • Research Site

    Highland Park, Illinois

  • Research Site

    Honolulu, Hawaii

  • Research Site

    Houma, Louisiana

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Huntington, West Virginia, 25701

  • Research Site

    Indianapolis, Indiana, 46202

  • Research Site

    Indianapolis, Indiana

  • Research Site

    Iowa City, Iowa, 52242

  • Research Site

    Iowa City, Iowa

  • Research Site

    Jackson, Michigan

  • Research Site

    Jackson, Mississippi

  • Research Site

    Jacksonville, North Carolina

  • Research Site

    Joliet, Illinois, 60435

  • Research Site

    Joplin, Missouri

  • Research Site

    Kalamazoo, Michigan

  • Research Site

    Kalispell, Montana, 59901

  • Research Site

    Kansas City, Kansas, 66112

  • Research Site

    Kansas City, Kansas

  • Research Site

    Kansas City, Missouri

  • Research Site

    Kenner, Louisiana, 70065

  • Research Site

    Kennewick, Washington, 99336

  • Research Site

    Kenosha, Wisconsin

  • Research Site

    Kinston, North Carolina

  • Research Site

    Kirkland, Washington, 98034

  • Research Site

    Kuakini, Hawaii

  • Research Site

    La Crosse, Wisconsin, 54601

  • Research Site

    Ladysmith, Wisconsin, 54848

  • Research Site

    Lafayette, Colorado, 80026

  • Research Site

    Lawrence, Kansas

  • Research Site

    Lebanon, New Hampshire, 03756

  • Research Site

    Lebanon, Pennsylvania, 17042

  • Research Site

    Lee's Summit, Missouri

  • Research Site

    Lewisburg, Pennsylvania, 17837

  • Research Site

    Lexington, Kentucky, 40509

  • Research Site

    Lincoln, Nebraska, 68506

  • Research Site

    Lincoln, Nebraska, 68510

  • Research Site

    Lone Tree, Colorado, 80124

  • Research Site

    Los Angeles, California, 70360

  • Research Site

    Los Angeles, California, 90027

  • Research Site

    Los Angeles, California, 90033

  • Research Site

    Los Angeles, California

  • Research Site

    Louisville, Kentucky

  • Research Site

    Lubbock, Texas, 79415

  • Research Site

    Lubbock, Texas, 79430

  • Research Site

    Lubbock, Texas

  • Research Site

    Lynchburg, Virginia

  • Research Site

    Macon, Georgia

  • Research Site

    Manchester, New Hampshire, 03102

  • Research Site

    Mankato, Minnesota, 56001

  • Research Site

    Maple Grove, Minnesota, 55369

  • Research Site

    Maplewood, Minnesota

  • Research Site

    Marinette, Wisconsin, 54143

  • Research Site

    Marshfield, Wisconsin, 54449

  • Research Site

    Martinez, California

  • Research Site

    Mason City, Iowa, 50401

  • Research Site

    Mason City, Iowa

  • Research Site

    Maumee, Ohio

  • Research Site

    Maywood, Illinois

  • Research Site

    Mechanicsville, Virginia, 23116

  • Research Site

    Media, Pennsylvania

  • Research Site

    Menomonee Falls, Wisconsin

  • Research Site

    Meridian, Idaho

  • Research Site

    Miami, Florida, 33136

  • Research Site

    Midlothian, Virginia

  • Research Site

    Milwaukee, Wisconsin

  • Research Site

    Minneapolis, Minnesota

  • Research Site

    Minocqua, Wisconsin, 54548

  • Research Site

    Minot, North Dakota

  • Research Site

    Mishawaka, Indiana

  • Research Site

    Monroe, Louisiana, 71202

  • Research Site

    Morgantown, West Virginia, 26506

  • Research Site

    Morristown, New Jersey, 07960

  • Research Site

    Mount Holly, New Jersey

  • Research Site

    Mount Vernon, Illinois

  • Research Site

    Mukwonago, Wisconsin

  • Research Site

    Muncie, Indiana

  • Research Site

    Munster, Indiana, 46321

  • Research Site

    Munster, Indiana

  • Research Site

    Murray, Utah

  • Research Site

    Muskegon, Michigan

  • Research Site

    Nampa, Idaho

  • Research Site

    Nashua, New Hampshire, 03063

  • Research Site

    New Brunswick, New Jersey

  • Research Site

    New Haven, Connecticut

  • Research Site

    New Hyde Park, New York, 11042

  • Research Site

    New Orleans, Louisiana

  • Research Site

    New York, New York

  • Research Site

    Newark, Delaware, 19713

  • Research Site

    Newark, Delaware

  • Research Site

    Newport Beach, California, 92663

  • Research Site

    Newton, Kansas

  • Research Site

    Norfolk, Nebraska, 68701

  • Research Site

    North Haven, Connecticut

  • Research Site

    Oakland, California, 94611

  • Research Site

    Oconomowoc, Wisconsin

  • Research Site

    Ogden, Utah, 84403

  • Research Site

    Oklahoma City, Oklahoma

  • Research Site

    Olathe, Kansas

  • Research Site

    Omaha, Nebraska, 68114

  • Research Site

    Omaha, Nebraska, 68124

  • Research Site

    Omaha, Nebraska

  • Research Site

    Orange, Connecticut

  • Research Site

    Oregon, Ohio

  • Research Site

    Orlando, Florida, 32806

  • Research Site

    Palo Alto, California

  • Research Site

    Paoli, Pennsylvania, 19301

  • Research Site

    Paoli, Pennsylvania

  • Research Site

    Paradise, California

  • Research Site

    Parkersburg, West Virginia, 26101

  • Research Site

    Parma, Ohio, 44129

  • Research Site

    Peoria, Illinois

  • Research Site

    Perrysburg, Ohio, 43551

  • Research Site

    Philadelphia, Pennsylvania

  • Research Site

    Phoenixville, Pennsylvania

  • Research Site

    Pinehurst, North Carolina

  • Research Site

    Pittsburgh, Pennsylvania

  • Research Site

    Pittsfield, Massachusetts

  • Research Site

    Plantation, Florida, 33324

  • Research Site

    Plymouth, Indiana

  • Research Site

    Pontiac, Michigan, 48341

  • Research Site

    Port Huron, Michigan, 48060

  • Research Site

    Portland, Maine

  • Research Site

    Portland, Oregon

  • Research Site

    Post Falls, Idaho, 83854

  • Research Site

    Poulsbo, Washington, 98370

  • Research Site

    Provo, Utah

  • Research Site

    Reading, Pennsylvania, 19605

  • Research Site

    Rice Lake, Wisconsin, 54868

  • Research Site

    Richmond, Virginia

  • Research Site

    Rochester, Minnesota

  • Research Site

    Rochester, New York, 14642

  • Research Site

    Rockford, Illinois, 61114

  • Research Site

    Rockport, Maine

  • Research Site

    Roseville, California, 95661

  • Research Site

    Roseville, California

  • Research Site

    Round Rock, Texas, 78665

  • Research Site

    Royal Oak, Michigan, 48073

  • Research Site

    Royal Oak, Michigan

  • Research Site

    Sacramento, California, 95816-5680

  • Research Site

    Saint Cloud, Minnesota, 56303

  • Research Site

    Saint Joseph, Michigan

  • Research Site

    Saint Louis Park, Minnesota

  • Research Site

    Saint Paul, Minnesota

  • Research Site

    Salina, Kansas

  • Research Site

    San Francisco, California, 94115

  • Research Site

    San Jose, California

  • Research Site

    San Leandro, California, 94577

  • Research Site

    San Marcos, California, 92078

  • Research Site

    Sanford, Maine, 04073

  • Research Site

    Santa Cruz, California

  • Research Site

    Santa Rosa, California, 95403

  • Research Site

    Savannah, Georgia, 31405

  • Research Site

    Scarborough, Maine, 04074

  • Research Site

    Seattle, Washington, 98109

Other trials in United States

Germany65 sites

  • Research Site

    Aachen, 52074

  • Research Site

    Augsburg, 86150

  • Research Site

    Baden-Baden, 76532

  • Research Site

    Berlin, 10117

  • Research Site

    Berlin, 10367

  • Research Site

    Berlin, 13125

  • Research Site

    Berlin, 13589

  • Research Site

    Berlin, 14169

  • Research Site

    Bonn, 53113

  • Research Site

    Bottrop, 46236

  • Research Site

    Brandenburg, 14770

  • Research Site

    Bremen, 28177

  • Research Site

    Chemnitz, 09116

  • Research Site

    Cologne, 50924

  • Research Site

    Deggendorf, 94469

  • Research Site

    Dresden, 01307

  • Research Site

    Düsseldorf, 40225

  • Research Site

    Düsseldorf, 40235

  • Research Site

    Ebersberg, 85560

  • Research Site

    Eggenfelden, 84307

  • Research Site

    Erfurt, 99085

  • Research Site

    Erlangen, 91054

  • Research Site

    Essen, 45136

  • Research Site

    Essen, 45147

  • Research Site

    Esslingen am Neckar, 73730

  • Research Site

    Frankfurt am Main, 65929

  • Research Site

    Freiburg im Breisgau, 79106

  • Research Site

    Fulda, 36043

  • Research Site

    Fürth, 90766

  • Research Site

    Gera, 07548

  • Research Site

    Gifhorn, 38518

  • Research Site

    Halle, 06120

  • Research Site

    Hamburg, 20246

  • Research Site

    Hamelin, 31785

  • Research Site

    Hanover, 30177

  • Research Site

    Hanover, 30559

  • Research Site

    Hanover, 30625

  • Research Site

    Hildesheim, 31134

  • Research Site

    Karlsruhe, 76135

  • Research Site

    Kassel, 34117

  • Research Site

    Koblenz Am Rhein, 56068

  • Research Site

    Leipzig, 04103

  • Research Site

    Mainz Am Rhein, 55131

  • Research Site

    Mannheim, 68167

  • Research Site

    Memmingen, 87700

  • Research Site

    Mühlhausen, 99974

  • Research Site

    Mühlheim An Der Ruhr, 45468

  • Research Site

    München, 80337

  • Research Site

    München, 80634

  • Research Site

    München, 81675

  • Research Site

    Münster, 48149

  • Research Site

    Nordhausen, 99734

  • Research Site

    Offenbach, 63069

  • Research Site

    Onkologisch Hämatologische Sch, 28209

  • Research Site

    Paderborn, 33098

  • Research Site

    Ravensburg, 88212

  • Research Site

    Recklinghausen, 45659

  • Research Site

    Rostock, 18059

  • Research Site

    Rotenburg (Wümme), 27356

  • Research Site

    Saarbrücken, 66113

  • Research Site

    Schweinfurt, 97421

  • Research Site

    Stendal, 39576

  • Research Site

    Tübingen, 72076

  • Research Site

    Ulm, 89075

  • Research Site

    Witten, 58452

Other trials in Germany

Spain38 sites

  • Research Site

    A Coruña, 15006

  • Research Site

    Ávila, 5004

  • Research Site

    Badajoz, 06008

  • Research Site

    Badalona, 08916

  • Research Site

    Barcelona, 08025

  • Research Site

    Barcelona, 08028

  • Research Site

    Barcelona, 08035

  • Research Site

    Cáceres, 10003

  • Research Site

    Castellon, 12002

  • Research Site

    Córdoba, 14004

  • Research Site

    Elche(Alicante), 03202

  • Research Site

    Girona, 17007

  • Research Site

    Hosp de Llobregat(Barcelona), 08907

  • Research Site

    Jaén, 23007

  • Research Site

    La Laguna (Tenerife), 38320

  • Research Site

    Lleida, 25198

  • Research Site

    Lugo, 27003

  • Research Site

    Madrid, 28007

  • Research Site

    Madrid, 28033

  • Research Site

    Madrid, 28034

  • Research Site

    Madrid, 28040

  • Research Site

    Madrid, 28041

  • Research Site

    Málaga, 29010

  • Research Site

    Palma de Mallorca, 07010

  • Research Site

    Pamplona, 31008

  • Research Site

    Pozuelo de Alarcón, 28223

  • Research Site

    Reus, 43204

  • Research Site

    Sabadell(Barcelona), 08208

  • Research Site

    Salamanca, 37007

  • Research Site

    San Sebastián, 20014

  • Research Site

    Santiago de Compostela, 15706

  • Research Site

    Seville, 41009

  • Research Site

    Seville, 41013

  • Research Site

    Terrassa(Barcelona), 08227

  • Research Site

    Toledo, 45004

  • Research Site

    Valencia, 46009

  • Research Site

    Valencia, 46010

  • Research Site

    Zaragoza, 50009

Other trials in Spain

Japan25 sites

  • Research Site

    Chiba, 260-8717

  • Research Site

    Chūōku, 104-0045

  • Research Site

    Chūōku, 104-8560

  • Research Site

    Fukuoka, 811-1395

  • Research Site

    Hidaka-shi, 350-1298

  • Research Site

    Hiroshima, 730-8518

  • Research Site

    Isehara-shi, 259-1193

  • Research Site

    Kagoshima, 892-0833

  • Research Site

    Kashiwa, 277-8577

  • Research Site

    Kawasaki-shi, 216-8511

  • Research Site

    Kōtoku, 135-8550

  • Research Site

    Kyoto, 606-8507

  • Research Site

    Matsuyama, 791-0280

  • Research Site

    Morioka, 028-3695

  • Research Site

    Nagoya, 464-8681

  • Research Site

    Nagoya, 467-8602

  • Research Site

    Nankoku-shi, 783-8505

  • Research Site

    Niigata, 951-8566

  • Research Site

    Osaka, 540-0006

  • Research Site

    Osaka, 541-8567

  • Research Site

    Ota-shi, 373-8550

  • Research Site

    Sapporo, 003-0804

  • Research Site

    Shinagawa-ku, 142-8666

  • Research Site

    Shizuoka, 411-8777

  • Research Site

    Suita, 565-0871

Other trials in Japan

France24 sites

  • Research Site

    Avignon, 84918

  • Research Site

    Besançon, 25030

  • Research Site

    Bordeaux, 33000

  • Research Site

    Brest, 29609

  • Research Site

    Caen, 14076

  • Research Site

    Clermont-Ferrand, 63011

  • Research Site

    Dechy, 59187

  • Research Site

    La Roche-sur-Yon, 85025

  • Research Site

    Lille, 59020

  • Research Site

    Limoges, 87042

  • Research Site

    Lyon, 69373

  • Research Site

    Marseille, 13273

  • Research Site

    Marseille

  • Research Site

    Montpellier, 34298

  • Research Site

    Nantes, 44202

  • Research Site

    Nice, 06100

  • Research Site

    Paris, 75010

  • Research Site

    Plerin SUR MER, 22190

  • Research Site

    Rennes, 35042

  • Research Site

    Rouen, 76038

  • Research Site

    Saint-Cloud, 92211

  • Research Site

    Strasbourg, 67065

  • Research Site

    Toulouse, 31076

  • Research Site

    Villejuif, 94805

Other trials in France

United Kingdom22 sites

  • Research Site

    Belfast, BT9 7AB

  • Research Site

    Birmingham, B15 2TH

  • Research Site

    Bournemouth, BH7 7DW

  • Research Site

    Bristol, BS2 8ED

  • Research Site

    Cambridge, CB2 0QQ

  • Research Site

    Cardiff, CF14 2TL

  • Research Site

    Dudley, DY1 2HQ

  • Research Site

    Edinburgh, EH4 2XR

  • Research Site

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Italy20 sites

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    Castellanza Varese, 21053

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About this study

Official title: 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

Read the 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.

Conditions
Breast Cancer
Being tested
Olaparib, Placebo
Keywords
Breast Cancer, Adjuvant, Olaparib, BRCA 1/2, HER2
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Also called Lynparza

    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

  • PlaceboDrug

    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

Study groups in NCT02032823
Study groupRoleWhat they receive
OlaparibExperimentalOlaparib tablets 300mg b.i.d. p.o.
Receives: Drug: Olaparib
PlaceboPlacebo comparatorPlacebo tablets b.i.d. p.o.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

Secondary outcomes (7)

  1. 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

    Measured: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)

  2. Overall Survival (OS)

    An OS event is defined as death by any cause.

    Measured: From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)

  3. 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.

    Measured: From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)

  4. 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.

    Measured: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

  5. 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.

    Measured: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

  6. 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.

    Measured: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

  7. 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.

    Measured: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2014 (estimated)
  2. Study start22 Apr 2014
  3. Primary completion27 Mar 2020
  4. Study completion28 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,837 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02032823
Sponsor's protocol ID
D081CC00006
Other IDs
NSABP B-55, 2024-511096-15-00, 2013-003839-30
Acronym
OlympiA
Status last verified
Jul 2026
First submitted
3 Jan 2014
Last updated
14 Jul 2026
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38301187

  • 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.

    PubMed 35594464

  • 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.

    PubMed 34081848

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olaparib in people with Breast Cancer, run by AstraZeneca at 698 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 698 sites in United States, Germany, Spain, Japan, France and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Disease Free Survival (IDFS) (time frame: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02032823, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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