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
5 other identifiers
interventional
1,837
23 countries
682
Brief Summary
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Apr 2014
Longer than P75 for phase_3 breast-cancer
682 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2014
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedStudy Start
First participant enrolled
April 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2020
CompletedResults Posted
Study results publicly available
December 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2029
ExpectedMay 6, 2026
April 1, 2026
5.9 years
January 3, 2014
September 24, 2021
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Secondary Outcomes (7)
Distant Disease Free Survival (DDFS)
From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Overall Survival (OS)
From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)
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
From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
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
6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
- +2 more secondary outcomes
Study Arms (2)
Olaparib
EXPERIMENTALOlaparib tablets 300mg b.i.d. p.o.
Placebo
PLACEBO COMPARATORPlacebo tablets b.i.d. p.o.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Breast International Groupcollaborator
- NRG Oncologycollaborator
- Myriad Genetic Laboratories, Inc.collaborator
- The Breast Adjuvant Study Teamcollaborator
- Merck Sharp & Dohme LLCcollaborator
- Frontier Science & Technology Research Foundation, Inc.collaborator
Study Sites (698)
Research Site
Anchorage, Alabama, 99508, United States
Research Site
Anchorage, Alaska, 99508, United States
Research Site
Gilbert, Arizona, 85234, United States
Research Site
Fort Smith, Arkansas, United States
Research Site
Baldwin Park, California, United States
Research Site
Berkeley, California, 94704, United States
Research Site
Duarte, California, 91010, United States
Research Site
Fontana, California, 92335, United States
Research Site
Fresno, California, United States
Research Site
Greenbrae, California, 94904, United States
Research Site
Los Angeles, California, 70360, United States
Research Site
Los Angeles, California, 90027, United States
Research Site
Los Angeles, California, 90033, United States
Research Site
Los Angeles, California, United States
Research Site
Martinez, California, United States
Research Site
Newport Beach, California, 92663, United States
Research Site
Oakland, California, 94611, United States
Research Site
Palo Alto, California, United States
Research Site
Paradise, California, United States
Research Site
Roseville, California, 95661, United States
Research Site
Roseville, California, United States
Research Site
Sacramento, California, 95816-5680, United States
Research Site
San Francisco, California, 94115, United States
Research Site
San Jose, California, United States
Research Site
San Leandro, California, 94577, United States
Research Site
San Marcos, California, 92078, United States
Research Site
Santa Cruz, California, United States
Research Site
Santa Rosa, California, 95403, United States
Research Site
South San Francisco, California, United States
Research Site
Stockton, California, United States
Research Site
Sunnyvale, California, 94086, United States
Research Site
Sunnyvale, California, United States
Research Site
Vacaville, California, 95688, United States
Research Site
Vallejo, California, 94589, United States
Research Site
Woodland Hills, California, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Colorado Springs, Colorado, 80907, United States
Research Site
Denver, Colorado, 80205, United States
Research Site
Edwards, Colorado, United States
Research Site
Fort Collins, Colorado, United States
Research Site
Lafayette, Colorado, 80026, United States
Research Site
Lone Tree, Colorado, 80124, United States
Research Site
Derby, Connecticut, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Guilford, Connecticut, United States
Research Site
New Haven, Connecticut, United States
Research Site
North Haven, Connecticut, United States
Research Site
Orange, Connecticut, United States
Research Site
Torrington, Connecticut, United States
Research Site
Trumbull, Connecticut, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Newark, Delaware, 19713, United States
Research Site
Newark, Delaware, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Daytona Beach, Florida, 32114, United States
Research Site
Deerfield Beach, Florida, United States
Research Site
Gainesville, Florida, United States
Research Site
Miami, Florida, 33136, United States
Research Site
Orlando, Florida, 32806, United States
Research Site
Plantation, Florida, 33324, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Columbus, Georgia, 31904, United States
Research Site
Decatur, Georgia, United States
Research Site
Macon, Georgia, United States
Research Site
Savannah, Georgia, 31405, United States
Research Site
Valdosta, Georgia, 31602, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Kuakini, Hawaii, United States
Research Site
‘Aiea, Hawaii, United States
Research Site
Boise, Idaho, United States
Research Site
Coeur d'Alene, Idaho, 83814, United States
Research Site
Fruitland, Idaho, United States
Research Site
Meridian, Idaho, United States
Research Site
Nampa, Idaho, United States
Research Site
Post Falls, Idaho, 83854, United States
Research Site
Twin Falls, Idaho, United States
Research Site
Centralia, Illinois, United States
Research Site
Chicago, Illinois, 60608, United States
Research Site
Chicago, Illinois, 60611, United States
Research Site
Chicago, Illinois, 60625, United States
Research Site
Chicago, Illinois, United States
Research Site
Decatur, Illinois, United States
Research Site
Effingham, Illinois, United States
Research Site
Elmhurst, Illinois, 60126, United States
Research Site
Evanston, Illinois, United States
Research Site
Glenview, Illinois, United States
Research Site
Highland Park, Illinois, United States
Research Site
Joliet, Illinois, 60435, United States
Research Site
Maywood, Illinois, United States
Research Site
Mount Vernon, Illinois, United States
Research Site
Peoria, Illinois, United States
Research Site
Rockford, Illinois, 61114, United States
Research Site
Warrenville, Illinois, United States
Research Site
Elkhart, Indiana, United States
Research Site
Fort Wayne, Indiana, 46845, United States
Research Site
Fort Wayne, Indiana, United States
Research Site
Indianapolis, Indiana, 46202, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Mishawaka, Indiana, United States
Research Site
Muncie, Indiana, United States
Research Site
Munster, Indiana, 46321, United States
Research Site
Munster, Indiana, United States
Research Site
Plymouth, Indiana, United States
Research Site
South Bend, Indiana, United States
Research Site
Westville, Indiana, United States
Research Site
Ames, Iowa, 50010, United States
Research Site
Ames, Iowa, United States
Research Site
Bettendorf, Iowa, 52722, United States
Research Site
Cedar Rapids, Iowa, 52403, United States
Research Site
Davenport, Iowa, 52803, United States
Research Site
Davenport, Iowa, 52807, United States
Research Site
Iowa City, Iowa, 52242, United States
Research Site
Iowa City, Iowa, United States
Research Site
Mason City, Iowa, 50401, United States
Research Site
Mason City, Iowa, United States
Research Site
Chanute, Kansas, United States
Research Site
El Dorado, Kansas, United States
Research Site
Fairway, Kansas, 66205, United States
Research Site
Garden City, Kansas, United States
Research Site
Hays, Kansas, United States
Research Site
Kansas City, Kansas, 66112, United States
Research Site
Kansas City, Kansas, United States
Research Site
Lawrence, Kansas, United States
Research Site
Newton, Kansas, United States
Research Site
Olathe, Kansas, United States
Research Site
Salina, Kansas, United States
Research Site
Topeka, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Winfield, Kansas, United States
Research Site
Lexington, Kentucky, 40509, United States
Research Site
Louisville, Kentucky, United States
Research Site
Baton Rouge, Louisiana, 70809, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Covington, Louisiana, United States
Research Site
Houma, Louisiana, United States
Research Site
Kenner, Louisiana, 70065, United States
Research Site
Monroe, Louisiana, 71202, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Shreveport, Louisiana, 71103, United States
Research Site
Shreveport, Louisiana, 71105, United States
Research Site
Slidell, Louisiana, 70458, United States
Research Site
Augusta, Maine, 04330, United States
Research Site
Bangor, Maine, United States
Research Site
Belfast, Maine, 4915, United States
Research Site
Biddeford, Maine, 04005, United States
Research Site
Portland, Maine, United States
Research Site
Rockport, Maine, United States
Research Site
Sanford, Maine, 04073, United States
Research Site
Scarborough, Maine, 04074, United States
Research Site
Baltimore, Maryland, 21202, United States
Research Site
Baltimore, Maryland, 21287, United States
Research Site
Baltimore, Maryland, United States
Research Site
Bethesda, Maryland, 20814, United States
Research Site
Easton, Maryland, United States
Research Site
Frederick, Maryland, 21701, United States
Research Site
Frederick, Maryland, 21702, United States
Research Site
Frederick, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Pittsfield, Massachusetts, United States
Research Site
Springfield, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Flint, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
Jackson, Michigan, United States
Research Site
Kalamazoo, Michigan, United States
Research Site
Muskegon, Michigan, United States
Research Site
Pontiac, Michigan, 48341, United States
Research Site
Port Huron, Michigan, 48060, United States
Research Site
Royal Oak, Michigan, 48073, United States
Research Site
Royal Oak, Michigan, United States
Research Site
Saint Joseph, Michigan, United States
Research Site
Southfield, Michigan, United States
Research Site
Traverse City, Michigan, United States
Research Site
Troy, Michigan, United States
Research Site
Warren, Michigan, United States
Research Site
Bemidji, Minnesota, 56601, United States
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, 56001, United States
Research Site
Maple Grove, Minnesota, 55369, United States
Research Site
Maplewood, Minnesota, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Rochester, Minnesota, United States
Research Site
Saint Cloud, Minnesota, 56303, United States
Research Site
Saint Louis Park, Minnesota, United States
Research Site
Saint Paul, Minnesota, United States
Research Site
Shakopee, Minnesota, 55379, United States
Research Site
Waconia, Minnesota, United States
Research Site
Woodbury, Minnesota, United States
Research Site
Jackson, Mississippi, United States
Research Site
Cape Girardeau, Missouri, United States
Research Site
Joplin, Missouri, United States
Research Site
Kansas City, Missouri, United States
Research Site
Lee's Summit, Missouri, United States
Research Site
Springfield, Missouri, 65807, United States
Research Site
Springfield, Missouri, United States
Research Site
St Louis, Missouri, 63109, United States
Research Site
St Louis, Missouri, 63141, United States
Research Site
St Louis, Missouri, United States
Research Site
Bozeman, Montana, 59715, United States
Research Site
Kalispell, Montana, 59901, United States
Research Site
Grand Island, Nebraska, 68803, United States
Research Site
Lincoln, Nebraska, 68506, United States
Research Site
Lincoln, Nebraska, 68510, United States
Research Site
Norfolk, Nebraska, 68701, United States
Research Site
Omaha, Nebraska, 68114, United States
Research Site
Omaha, Nebraska, 68124, United States
Research Site
Omaha, Nebraska, United States
Research Site
Lebanon, New Hampshire, 03756, United States
Research Site
Manchester, New Hampshire, 03102, United States
Research Site
Nashua, New Hampshire, 03063, United States
Research Site
Flemington, New Jersey, 08822, United States
Research Site
Hamilton, New Jersey, United States
Research Site
Morristown, New Jersey, 07960, United States
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
Albuquerque, New Mexico, 87102, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Brooklyn, New York, 11215, United States
Research Site
Charlotte, New York, United States
Research Site
East Syracuse, New York, United States
Research Site
New Hyde Park, New York, 11042, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, 14642, United States
Research Site
The Bronx, New York, United States
Research Site
White Plains, New York, 10601, United States
Research Site
Albemarle, North Carolina, 28002, United States
Research Site
Asheville, North Carolina, United States
Research Site
Charlotte, North Carolina, United States
Research Site
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, 28791, United States
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
Fargo, North Dakota, 58102, United States
Research Site
Grand Forks, North Dakota, 58201, United States
Research Site
Minot, North Dakota, United States
Research Site
Akron, Ohio, United States
Research Site
Beachwood, Ohio, 44122, United States
Research Site
Canton, Ohio, 44710, United States
Research Site
Cleveland, Ohio, 44106, United States
Research Site
Cleveland, Ohio, 44130, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Columbus, Ohio, 43215, United States
Research Site
Columbus, Ohio, United States
Research Site
Dayton, Ohio, 45429, United States
Research Site
Dayton, Ohio, United States
Research Site
Elyria, Ohio, 44035, United States
Research Site
Englewood, Ohio, 45415, United States
Research Site
Findlay, Ohio, 45840, United States
Research Site
Maumee, Ohio, United States
Research Site
Oregon, Ohio, United States
Research Site
Parma, Ohio, 44129, United States
Research Site
Perrysburg, Ohio, 43551, United States
Research Site
Springfield, Ohio, 45504, United States
Research Site
Sylvania, Ohio, United States
Research Site
Toledo, Ohio, United States
Research Site
Zanesville, Ohio, 43701, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Portland, Oregon, United States
Research Site
Abington, Pennsylvania, United States
Research Site
Broomall, Pennsylvania, 19008, United States
Research Site
Bryn Mawr, Pennsylvania, United States
Research Site
Clairton, Pennsylvania, 15025, United States
Research Site
Danville, Pennsylvania, United States
Research Site
Drexel Hill, Pennsylvania, United States
Research Site
Ephrata, Pennsylvania, 17522, United States
Research Site
Gettysburg, Pennsylvania, 17325, United States
Research Site
Harrisburg, Pennsylvania, United States
Research Site
Hazleton, Pennsylvania, United States
Research Site
Hershey, Pennsylvania, United States
Research Site
Lebanon, Pennsylvania, 17042, United States
Research Site
Lewisburg, Pennsylvania, 17837, United States
Research Site
Media, Pennsylvania, United States
Research Site
Paoli, Pennsylvania, 19301, United States
Research Site
Paoli, Pennsylvania, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Phoenixville, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Reading, Pennsylvania, 19605, United States
Research Site
State College, Pennsylvania, United States
Research Site
West Reading, Pennsylvania, 19611, United States
Research Site
West Reading, Pennsylvania, United States
Research Site
Wilkes-Barre, Pennsylvania, United States
Research Site
Williamsport, Pennsylvania, 17701, United States
Research Site
Williamsport, Pennsylvania, United States
Research Site
Wynnewood, Pennsylvania, 19096, United States
Research Site
York, Pennsylvania, United States
Research Site
Anderson, South Carolina, United States
Research Site
Charleston, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Greenwood, South Carolina, United States
Research Site
Greer, South Carolina, United States
Research Site
Seneca, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Sioux Falls, South Dakota, 57105, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Lubbock, Texas, 79415, United States
Research Site
Lubbock, Texas, 79430, United States
Research Site
Lubbock, Texas, United States
Research Site
Round Rock, Texas, 78665, United States
Research Site
Temple, Texas, United States
Research Site
American Fork, Utah, United States
Research Site
Murray, Utah, United States
Research Site
Ogden, Utah, 84403, United States
Research Site
Provo, Utah, United States
Research Site
St. George, Utah, United States
Research Site
Berlin Corners, Vermont, United States
Research Site
Burlington, Vermont, United States
Research Site
Annandale, Virginia, 22003, United States
Research Site
Fairfax, Virginia, United States
Research Site
Fredericksburg, Virginia, United States
Research Site
Lynchburg, Virginia, United States
Research Site
Mechanicsville, Virginia, 23116, United States
Research Site
Midlothian, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
South Hill, Virginia, United States
Research Site
Centralia, Washington, 98531, United States
Research Site
Kennewick, Washington, 99336, United States
Research Site
Kirkland, Washington, 98034, United States
Research Site
Poulsbo, Washington, 98370, United States
Research Site
Seattle, Washington, 98109, United States
Research Site
Seattle, Washington, United States
Research Site
Charleston, West Virginia, United States
Research Site
Huntington, West Virginia, 25701, United States
Research Site
Morgantown, West Virginia, 26506, United States
Research Site
Parkersburg, West Virginia, 26101, United States
Research Site
Burlington, Wisconsin, United States
Research Site
Chippewa Falls, Wisconsin, 54729, United States
Research Site
Eau Claire, Wisconsin, 54701, United States
Research Site
Elkhorn, Wisconsin, United States
Research Site
Fond du Lac, Wisconsin, 54937, United States
Research Site
Grafton, Wisconsin, United States
Research Site
Green Bay, Wisconsin, 54303, United States
Research Site
Green Bay, Wisconsin, 54311-6519, United States
Research Site
Green Bay, Wisconsin, United States
Research Site
Kenosha, Wisconsin, United States
Research Site
La Crosse, Wisconsin, 54601, United States
Research Site
Ladysmith, Wisconsin, 54848, United States
Research Site
Marinette, Wisconsin, 54143, United States
Research Site
Marshfield, Wisconsin, 54449, United States
Research Site
Menomonee Falls, Wisconsin, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Minocqua, Wisconsin, 54548, United States
Research Site
Mukwonago, Wisconsin, United States
Research Site
Oconomowoc, Wisconsin, United States
Research Site
Rice Lake, Wisconsin, 54868, United States
Research Site
Stevens Point, Wisconsin, 54482, United States
Research Site
Summit, Wisconsin, United States
Research Site
Waukesha, Wisconsin, United States
Research Site
Wausau, Wisconsin, 54401, United States
Research Site
Wauwatosa, Wisconsin, United States
Research Site
West Allis, Wisconsin, United States
Research Site
Weston, Wisconsin, 54476, United States
Research Site
Wisconsin Rapids, Wisconsin, 54494, United States
Research Site
Berazategui, B1884BBF, Argentina
Research Site
CABA, C1113AAE, Argentina
Research Site
CABA, C1426ANZ, Argentina
Research Site
Córdoba, 5000, Argentina
Research Site
Córdoba, X5002AOQ, Argentina
Research Site
La Rioja, 5300, Argentina
Research Site
Mendoza, 5500, Argentina
Research Site
Rosario, S2000KZE, Argentina
Research Site
San Miguel de Tucumán, T4000IAK, Argentina
Research Site
Santa Fe, S3000FFU, Argentina
Research Site
Adelaide, 5000, Australia
Research Site
Auchenflower, 4066, Australia
Research Site
Concord, 2139, Australia
Research Site
Douglas, 4814, Australia
Research Site
Gosford, 2250, Australia
Research Site
Hobart, 7000, Australia
Research Site
Malvern, 3144, Australia
Research Site
Melbourne, 3000, Australia
Research Site
Nedlands, 6009, Australia
Research Site
Randwick, 2031, Australia
Research Site
South Brisbane, 4101, Australia
Research Site
Tamworth, 2340, Australia
Research Site
Tweed Heads, 2485, Australia
Research Site
Waratah, 2298, Australia
Research Site
Wendouree, 3355, Australia
Research Site
Graz, 8036, Austria
Research Site
Innsbruck, 6020, Austria
Research Site
Leoben, 8700, Austria
Research Site
Linz, 4010, Austria
Research Site
Linz, 4020, Austria
Research Site
Rankweil, 6830, Austria
Research Site
Ried, 4910, Austria
Research Site
Salzburg, 5020, Austria
Research Site
Sankt Veit an der Glan, 9300, Austria
Research Site
Vienna, 1090, Austria
Research Site
Vienna, 1130, Austria
Research Site
Vienna, 1160, Austria
Research Site
Villach, 9500, Austria
Research Site
Vöcklabruck, 4840, Austria
Research Site
Weiz, 8160, Austria
Research Site
Wels, 4600, Austria
Research Site
Anderlecht, 1070, Belgium
Research Site
Brussels, 1070, Belgium
Research Site
Brussels, 1090, Belgium
Research Site
Brussels, 1200, Belgium
Research Site
Charleroi, 6060, Belgium
Research Site
Edegem, 2650, Belgium
Research Site
Kortrijk, 8500, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Liège, 4000, Belgium
Research Site
Namur, 5000, Belgium
Research Site
Ostend, 8400, Belgium
Research Site
Edmonton, Alberta, T6G 1Z2, Canada
Research Site
Vancouver, British Columbia, V5Z 4E6, Canada
Research Site
Winnipeg, Manitoba, R3E 0V9, Canada
Research Site
Hamilton, Ontario, L8V 5C2, Canada
Research Site
Toronto, Ontario, M4N 3M5, Canada
Research Site
Greenfield Park, Quebec, J4V 2H1, Canada
Research Site
Montreal, Quebec, H2W 1T8, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Québec, Quebec, G1S 4L8, Canada
Research Site
Regina, Saskatchewan, S4T 7T1, Canada
Research Site
Saskatoon, Saskatchewan, S7N 4H4, Canada
Research Site
Beijing, 100006, China
Research Site
Beijing, 100021, China
Research Site
Beijing, 100730, China
Research Site
Changchun, 130061, China
Research Site
Chengdu, 610041, China
Research Site
Fuzhou, 350001, China
Research Site
Guangzhou, 510100, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310022, China
Research Site
Harbin, 150081, China
Research Site
Jinan, 250117, China
Research Site
Nanjing, 210029, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Shijiazhuang, 050020, China
Research Site
Tianjin, 300060, China
Research Site
Avignon, 84918, France
Research Site
Besançon, 25030, France
Research Site
Bordeaux, 33000, France
Research Site
Brest, 29609, France
Research Site
Caen, 14076, France
Research Site
Clermont-Ferrand, 63011, France
Research Site
Dechy, 59187, France
Research Site
La Roche-sur-Yon, 85025, France
Research Site
Lille, 59020, France
Research Site
Limoges, 87042, France
Research Site
Lyon, 69373, France
Research Site
Marseille, 13273, France
Research Site
Marseille, France
Research Site
Montpellier, 34298, France
Research Site
Nantes, 44202, France
Research Site
Nice, 06100, France
Research Site
Paris, 75010, France
Research Site
Plerin SUR MER, 22190, France
Research Site
Rennes, 35042, France
Research Site
Rouen, 76038, France
Research Site
Saint-Cloud, 92211, France
Research Site
Strasbourg, 67065, France
Research Site
Toulouse, 31076, France
Research Site
Villejuif, 94805, France
Research Site
Aachen, 52074, Germany
Research Site
Augsburg, 86150, Germany
Research Site
Baden-Baden, 76532, Germany
Research Site
Berlin, 10117, Germany
Research Site
Berlin, 10367, Germany
Research Site
Berlin, 13125, Germany
Research Site
Berlin, 13589, Germany
Research Site
Berlin, 14169, Germany
Research Site
Bonn, 53113, Germany
Research Site
Bottrop, 46236, Germany
Research Site
Brandenburg, 14770, Germany
Research Site
Bremen, 28177, Germany
Research Site
Chemnitz, 09116, Germany
Research Site
Cologne, 50924, Germany
Research Site
Deggendorf, 94469, Germany
Research Site
Dresden, 01307, Germany
Research Site
Düsseldorf, 40225, Germany
Research Site
Düsseldorf, 40235, Germany
Research Site
Ebersberg, 85560, Germany
Research Site
Eggenfelden, 84307, Germany
Research Site
Erfurt, 99085, Germany
Research Site
Erlangen, 91054, Germany
Research Site
Essen, 45136, Germany
Research Site
Essen, 45147, Germany
Research Site
Esslingen am Neckar, 73730, Germany
Research Site
Frankfurt am Main, 65929, Germany
Research Site
Freiburg im Breisgau, 79106, Germany
Research Site
Fulda, 36043, Germany
Research Site
Fürth, 90766, Germany
Research Site
Gera, 07548, Germany
Research Site
Gifhorn, 38518, Germany
Research Site
Halle, 06120, Germany
Research Site
Hamburg, 20246, Germany
Research Site
Hamelin, 31785, Germany
Research Site
Hanover, 30177, Germany
Research Site
Hanover, 30559, Germany
Research Site
Hanover, 30625, Germany
Research Site
Hildesheim, 31134, Germany
Research Site
Karlsruhe, 76135, Germany
Research Site
Kassel, 34117, Germany
Research Site
Koblenz Am Rhein, 56068, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Mainz Am Rhein, 55131, Germany
Research Site
Mannheim, 68167, Germany
Research Site
Memmingen, 87700, Germany
Research Site
Mühlhausen, 99974, Germany
Research Site
Mühlheim An Der Ruhr, 45468, Germany
Research Site
München, 80337, Germany
Research Site
München, 80634, Germany
Research Site
München, 81675, Germany
Research Site
Münster, 48149, Germany
Research Site
Nordhausen, 99734, Germany
Research Site
Offenbach, 63069, Germany
Research Site
Onkologisch Hämatologische Sch, 28209, Germany
Research Site
Paderborn, 33098, Germany
Research Site
Ravensburg, 88212, Germany
Research Site
Recklinghausen, 45659, Germany
Research Site
Rostock, 18059, Germany
Research Site
Rotenburg (Wümme), 27356, Germany
Research Site
Saarbrücken, 66113, Germany
Research Site
Schweinfurt, 97421, Germany
Research Site
Stendal, 39576, Germany
Research Site
Tübingen, 72076, Germany
Research Site
Ulm, 89075, Germany
Research Site
Witten, 58452, Germany
Research Site
Budapest, 1122, Hungary
Research Site
Budapest, 1145, Hungary
Research Site
Reykjavik, 101, Iceland
Research Site
Jerusalem, 91120, Israel
Research Site
Petah Tikva, 49100, Israel
Research Site
Ramat Gan, 5265601, Israel
Research Site
Tel Aviv, 6423906, Israel
Research Site
Bergamo, 24127, Italy
Research Site
Bologna, 40138, Italy
Research Site
Bolzano, 39100, Italy
Research Site
Castellanza Varese, 21053, Italy
Research Site
Lecce, 73100, Italy
Research Site
Legnago, 37045, Italy
Research Site
Milan, 20132, Italy
Research Site
Milan, 20141, Italy
Research Site
Modena, 41124, Italy
Research Site
Naples, 80131, Italy
Research Site
Nehrar, 37024, Italy
Research Site
Padova, 35128, Italy
Research Site
Palermo, 90146, Italy
Research Site
Pavia, 27100, Italy
Research Site
Perugia, 6156, Italy
Research Site
Prato, 59100, Italy
Research Site
Rimini, 47923, Italy
Research Site
Saronno, 21047, Italy
Research Site
Varese, 21100, Italy
Research Site
Viterbo, 01100, Italy
Research Site
Chiba, 260-8717, Japan
Research Site
Chūōku, 104-0045, Japan
Research Site
Chūōku, 104-8560, Japan
Research Site
Fukuoka, 811-1395, Japan
Research Site
Hidaka-shi, 350-1298, Japan
Research Site
Hiroshima, 730-8518, Japan
Research Site
Isehara-shi, 259-1193, Japan
Research Site
Kagoshima, 892-0833, Japan
Research Site
Kashiwa, 277-8577, Japan
Research Site
Kawasaki-shi, 216-8511, Japan
Research Site
Kōtoku, 135-8550, Japan
Research Site
Kyoto, 606-8507, Japan
Research Site
Matsuyama, 791-0280, Japan
Research Site
Morioka, 028-3695, Japan
Research Site
Nagoya, 464-8681, Japan
Research Site
Nagoya, 467-8602, Japan
Research Site
Nankoku-shi, 783-8505, Japan
Research Site
Niigata, 951-8566, Japan
Research Site
Osaka, 540-0006, Japan
Research Site
Osaka, 541-8567, Japan
Research Site
Ota-shi, 373-8550, Japan
Research Site
Sapporo, 003-0804, Japan
Research Site
Shinagawa-ku, 142-8666, Japan
Research Site
Shizuoka, 411-8777, Japan
Research Site
Suita, 565-0871, Japan
Research Site
Amsterdam, 1066 CX, Netherlands
Research Site
Breda, 4819 EV, Netherlands
Research Site
Geleen, 6162 BG, Netherlands
Research Site
Leiden, 2333 ZA, Netherlands
Research Site
Maastricht, 6202 AZ, Netherlands
Research Site
Rotterdam, 3015 GD, Netherlands
Research Site
Zaandam, 1502 DV, Netherlands
Research Site
Gdansk, 80-952, Poland
Research Site
Grzepnica, 72-003, Poland
Research Site
Lodz, 93-338, Poland
Research Site
Olsztyn, 10-228, Poland
Research Site
Poznan, 60-693, Poland
Research Site
Warsaw, 01-748, Poland
Research Site
Warsaw, 02-781, Poland
Research Site
Lisbon, 1099-023, Portugal
Research Site
Lisbon, 1400-038, Portugal
Research Site
Lisbon, 1500-650, Portugal
Research Site
Lisbon, 1998-018, Portugal
Research Site
Loures, 2674-514, Portugal
Research Site
Porto, 4200-072, Portugal
Research Site
San Juan, 00936, Puerto Rico
Research Site
Daegu, 41404, South Korea
Research Site
Goyang-si, 10408, South Korea
Research Site
Incheon, 21565, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 07985, South Korea
Research Site
A Coruña, 15006, Spain
Research Site
Ávila, 5004, Spain
Research Site
Badajoz, 06008, Spain
Research Site
Badalona, 08916, Spain
Research Site
Barcelona, 08025, Spain
Research Site
Barcelona, 08028, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Castellon, 12002, Spain
Research Site
Cáceres, 10003, Spain
Research Site
Córdoba, 14004, Spain
Research Site
Elche(Alicante), 03202, Spain
Research Site
Girona, 17007, Spain
Research Site
Hosp de Llobregat(Barcelona), 08907, Spain
Research Site
Jaén, 23007, Spain
Research Site
La Laguna (Tenerife), 38320, Spain
Research Site
Lleida, 25198, Spain
Research Site
Lugo, 27003, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28033, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28040, Spain
Research Site
Madrid, 28041, Spain
Research Site
Málaga, 29010, Spain
Research Site
Palma de Mallorca, 07010, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Pozuelo de Alarcón, 28223, Spain
Research Site
Reus,Tarragona, 43204, Spain
Research Site
Sabadell(Barcelona), 08208, Spain
Research Site
Salamanca, 37007, Spain
Research Site
San Sebastián, 20014, Spain
Research Site
Santiago de Compostela, 15706, Spain
Research Site
Seville, 41009, Spain
Research Site
Seville, 41013, Spain
Research Site
Terrassa(Barcelona), 08227, Spain
Research Site
Toledo, 45004, Spain
Research Site
Valencia, 46009, Spain
Research Site
Valencia, 46010, Spain
Research Site
Zaragoza, 50009, Spain
Research Site
Gothenburg, 413 45, Sweden
Research Site
Linköping, 581 85, Sweden
Research Site
Malmö, 21428, Sweden
Research Site
Solna, 171 64, Sweden
Research Site
Stockholm, 118 83, Sweden
Research Site
Umeå, 90185, Sweden
Research Site
Bern, 3010, Switzerland
Research Site
Lausanne, 1011, Switzerland
Research Site
Zurich, 8091, Switzerland
Research Site
Changhua, 50006, Taiwan
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taichung, 407, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Tainan, 73657, Taiwan
Research Site
Taipei, 10048, Taiwan
Research Site
Taipei, 10449, Taiwan
Research Site
Taipei, 11217, Taiwan
Research Site
Taipei, 11490, Taiwan
Research Site
Taoyuan, 333, Taiwan
Research Site
Belfast, BT9 7AB, United Kingdom
Research Site
Birmingham, B15 2TH, United Kingdom
Research Site
Bournemouth, BH7 7DW, United Kingdom
Research Site
Bristol, BS2 8ED, United Kingdom
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
Cardiff, CF14 2TL, United Kingdom
Research Site
Dudley, DY1 2HQ, United Kingdom
Research Site
Edinburgh, EH4 2XR, United Kingdom
Research Site
Glasgow, G12 0YN, United Kingdom
Research Site
Leeds, LS9 7TF, United Kingdom
Research Site
London, E1 1BB, United Kingdom
Research Site
London, NW1 2PG, United Kingdom
Research Site
London, SE1 9RT, United Kingdom
Research Site
London, SW17 0QT, United Kingdom
Research Site
London, SW3 6JJ, United Kingdom
Research Site
Manchester, M20 4GJ, United Kingdom
Research Site
Nottingham, NG5 1PB, United Kingdom
Research Site
Oxford, OX3 7LE, United Kingdom
Research Site
Sheffield, S10 2SJ, United Kingdom
Research Site
Southampton, SO16 6YD, United Kingdom
Research Site
Stoke-on-Trent, ST4 6QG, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom
Related Publications (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.
PMID: 38301187DERIVEDPerachino 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.
PMID: 35594464DERIVEDTutt 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.
PMID: 34081848DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2014
First Posted
January 10, 2014
Study Start
April 22, 2014
Primary Completion
March 27, 2020
Study Completion (Estimated)
May 28, 2029
Last Updated
May 6, 2026
Results First Posted
December 8, 2021
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.