Clinical trial NCT02032823: Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Adjuvant
Olaparib
BRCA 1/2
HER2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Breast International Group
name: Frontier Science & Technology Research Foundation, Inc.
name: NRG Oncology
name: Myriad Genetic Laboratories, Inc.
name: The Breast Adjuvant Study Team
name: Merck Sharp & Dohme LLC
First posted: 2014-01-10
Enrollment: 1837
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Invasive Disease Free Survival (IDFS)
timeFrame: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Secondary outcomes:
measure: Distant Disease Free Survival (DDFS)
timeFrame: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
measure: Overall Survival (OS)
timeFrame: From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)
measure: 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
timeFrame: From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)
measure: Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
timeFrame: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
measure: Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
timeFrame: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
measure: 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
timeFrame: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
measure: 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
timeFrame: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
Other outcomes:
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facility: Research Site
state: Ohio
city: Sylvania
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Zanesville
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Abington
country: United States
facility: Research Site
state: Pennsylvania
city: Broomall
country: United States
facility: Research Site
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Research Site
state: Pennsylvania
city: Clairton
country: United States
facility: Research Site
state: Pennsylvania
city: Danville
country: United States
facility: Research Site
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Research Site
state: Pennsylvania
city: Ephrata
country: United States
facility: Research Site
state: Pennsylvania
city: Gettysburg
country: United States
facility: Research Site
state: Pennsylvania
city: Harrisburg
country: United States
facility: Research Site
state: Pennsylvania
city: Hazleton
country: United States
facility: Research Site
state: Pennsylvania
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Lebanon
country: United States
facility: Research Site
state: Pennsylvania
city: Lewisburg
country: United States
facility: Research Site
state: Pennsylvania
city: Media
country: United States
facility: Research Site
state: Pennsylvania
city: Paoli
country: United States
facility: Research Site
state: Pennsylvania
city: Paoli
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Phoenixville
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Reading
country: United States
facility: Research Site
state: Pennsylvania
city: State College
country: United States
facility: Research Site
state: Pennsylvania
city: West Reading
country: United States
facility: Research Site
state: Pennsylvania
city: West Reading
country: United States
facility: Research Site
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Research Site
state: Pennsylvania
city: Williamsport
country: United States
facility: Research Site
state: Pennsylvania
city: Williamsport
country: United States
facility: Research Site
state: Pennsylvania
city: Wynnewood
country: United States
facility: Research Site
state: Pennsylvania
city: York
country: United States
facility: Research Site
state: Pennsylvania
city: Anderson
country: United States
facility: Research Site
state: South Carolina
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Greenwood
country: United States
facility: Research Site
state: South Carolina
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Seneca
country: United States
facility: Research Site
state: South Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Research Site
state: South Dakota
city: Houston
country: United States
facility: Research Site
state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Round Rock
country: United States
facility: Research Site
state: Texas
city: Temple
country: United States
facility: Research Site
state: Texas
city: American Fork
country: United States
facility: Research Site
state: Utah
city: Murray
country: United States
facility: Research Site
state: Utah
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Provo
country: United States
facility: Research Site
state: Utah
city: Saint George
country: United States
facility: Research Site
state: Utah
city: Berlin
country: United States
facility: Research Site
state: Vermont
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Annandale
country: United States
facility: Research Site
state: Virginia
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Fredericksburg
country: United States
facility: Research Site
state: Virginia
city: Lynchburg
country: United States
facility: Research Site
state: Virginia
city: Mechanicsville
country: United States
facility: Research Site
state: Virginia
city: Midlothian
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: South Hill
country: United States
facility: Research Site
state: Virginia
city: Centralia
country: United States
facility: Research Site
state: Washington
city: Kennewick
country: United States
facility: Research Site
state: Washington
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Poulsbo
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Charleston
country: United States
facility: Research Site
state: West Virginia
city: Huntington
country: United States
facility: Research Site
state: West Virginia
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
city: Parkersburg
country: United States
facility: Research Site
state: West Virginia
city: Burlington
country: United States
facility: Research Site
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city: Chippewa Falls
country: United States
facility: Research Site
state: Wisconsin
city: Eau Claire
country: United States
facility: Research Site
state: Wisconsin
city: Elkhorn
country: United States
facility: Research Site
state: Wisconsin
city: Fond Du Lac
country: United States
facility: Research Site
state: Wisconsin
city: Grafton
country: United States
facility: Research Site
state: Wisconsin
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: Green Bay
country: United States
facility: Research Site
state: Wisconsin
city: Kenosha
country: United States
facility: Research Site
state: Wisconsin
city: La Crosse
country: United States
facility: Research Site
state: Wisconsin
city: Ladysmith
country: United States
facility: Research Site
state: Wisconsin
city: Marinette
country: United States
facility: Research Site
state: Wisconsin
city: Marshfield
country: United States
facility: Research Site
state: Wisconsin
city: Menomonee Falls
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Minocqua
country: United States
facility: Research Site
state: Wisconsin
city: Mukwonago
country: United States
facility: Research Site
state: Wisconsin
city: Oconomowoc
country: United States
facility: Research Site
state: Wisconsin
city: Rice Lake
country: United States
facility: Research Site
state: Wisconsin
city: Stevens Point
country: United States
facility: Research Site
state: Wisconsin
city: Summit
country: United States
facility: Research Site
state: Wisconsin
city: Waukesha
country: United States
facility: Research Site
state: Wisconsin
city: Wausau
country: United States
facility: Research Site
state: Wisconsin
city: Wauwatosa
country: United States
facility: Research Site
state: Wisconsin
city: West Allis
country: United States
facility: Research Site
state: Wisconsin
city: Weston
country: United States
facility: Research Site
state: Wisconsin
city: Wisconsin Rapids
country: United States
facility: Research Site
state: Wisconsin
city: Berazategui
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: La Rioja
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
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facility: Research Site
city: Santa Fe
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facility: Research Site
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country: Australia
facility: Research Site
city: Auchenflower
country: Australia
facility: Research Site
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country: Australia
facility: Research Site
city: Douglas
country: Australia
facility: Research Site
city: Gosford
country: Australia
facility: Research Site
city: Hobart
country: Australia
facility: Research Site
city: Malvern
country: Australia
facility: Research Site
city: Melbourne
country: Australia
facility: Research Site
city: Nedlands
country: Australia
facility: Research Site
city: Randwick
country: Australia
facility: Research Site
city: South Brisbane
country: Australia
facility: Research Site
city: Tamworth
country: Australia
facility: Research Site
city: Tweed Heads
country: Australia
facility: Research Site
city: Waratah
country: Australia
facility: Research Site
city: Wendouree
country: Australia
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Rankweil
country: Austria
facility: Research Site
city: Ried
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: St. Veit an der Glan
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Villach
country: Austria
facility: Research Site
city: Voecklabruck
country: Austria
facility: Research Site
city: Weiz
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Anderlecht
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Bruxelles
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facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Regina
country: Canada
facility: Research Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Besancon
country: France
facility: Research Site
city: Bordeaux Cedex
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facility: Research Site
city: Brest Cedex
country: France
facility: Research Site
city: Caen Cedex 05
country: France
facility: Research Site
city: Clermont Ferrand cedex 01
country: France
facility: Research Site
city: Dechy
country: France
facility: Research Site
city: La Roche sur Yon
country: France
facility: Research Site
city: Lille Cedex
country: France
facility: Research Site
city: Limoges Cedex
country: France
facility: Research Site
city: Lyon Cedex 08
country: France
facility: Research Site
city: Marseille cedex 09
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Paris Cedex 10
country: France
facility: Research Site
city: Plerin SUR MER
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Saint Cloud
country: France
facility: Research Site
city: STRASBOURG Cedex
country: France
facility: Research Site
city: Toulouse Cedex 3
country: France
facility: Research Site
city: Villejuif Cedex
country: France
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Baden-Baden
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Bottrop
country: Germany
facility: Research Site
city: Brandenburg
country: Germany
facility: Research Site
city: Bremen
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Deggendorf
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Ebersberg
country: Germany
facility: Research Site
city: Eggenfelden
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Esslingen am Neckar
country: Germany
facility: Research Site
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country: Germany
facility: Research Site
city: Freiburg im Breisgau
country: Germany
facility: Research Site
city: Fulda
country: Germany
facility: Research Site
city: Fürth
country: Germany
facility: Research Site
city: Gera
country: Germany
facility: Research Site
city: Gifhorn
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
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country: Germany
facility: Research Site
city: Hameln
country: Germany
facility: Research Site
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country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Karlsruhe
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facility: Research Site
city: Kassel
country: Germany
facility: Research Site
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country: Germany
facility: Research Site
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country: Germany
facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Germany
facility: Research Site
city: Memmingen
country: Germany
facility: Research Site
city: Mühlhausen
country: Germany
facility: Research Site
city: Mühlheim An Der Ruhr
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Nordhausen
country: Germany
facility: Research Site
city: Offenbach am Main
country: Germany
facility: Research Site
city: Onkologisch Hämatologische Sch
country: Germany
facility: Research Site
city: Paderborn
country: Germany
facility: Research Site
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country: Germany
facility: Research Site
city: Recklinghausen
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Rotenburg
country: Germany
facility: Research Site
city: Saarbrücken
country: Germany
facility: Research Site
city: Schweinfurt
country: Germany
facility: Research Site
city: Stendal
country: Germany
facility: Research Site
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country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
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country: Germany
facility: Research Site
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country: Hungary
facility: Research Site
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country: Hungary
facility: Research Site
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facility: Research Site
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facility: Research Site
city: Petah Tikva
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facility: Research Site
city: Ramat Gan
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facility: Research Site
city: Tel-Aviv
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facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
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country: Italy
facility: Research Site
city: Bolzano
country: Italy
facility: Research Site
city: Castellanza Varese
country: Italy
facility: Research Site
city: Lecce
country: Italy
facility: Research Site
city: Legnago
country: Italy
facility: Research Site
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country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Nehrar
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Prato
country: Italy
facility: Research Site
city: Rimini
country: Italy
facility: Research Site
city: Saronno
country: Italy
facility: Research Site
city: Varese
country: Italy
facility: Research Site
city: Viterbo
country: Italy
facility: Research Site
city: Chiba-shi
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Hidaka-shi
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Isehara-shi
country: Japan
facility: Research Site
city: Kagoshima-shi
country: Japan
facility: Research Site
city: Kashiwa
country: Japan
facility: Research Site
city: Kawasaki-shi
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
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country: Japan
facility: Research Site
city: Matsuyama-shi
country: Japan
facility: Research Site
city: Morioka-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Nagoya-shi
country: Japan
facility: Research Site
city: Nankoku-shi
country: Japan
facility: Research Site
city: Niigata-shi
country: Japan
facility: Research Site
city: Osaka-city
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Ota-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Suita-city
country: Japan
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
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country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Geleen
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Zaandam
country: Netherlands
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Grzepnica
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Loures
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: A Coruña
country: Spain
facility: Research Site
city: Avila
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Castelló de la Plana
country: Spain
facility: Research Site
city: Cáceres
country: Spain
facility: Research Site
city: Córdoba
country: Spain
facility: Research Site
city: Elche(Alicante)
country: Spain
facility: Research Site
city: Girona
country: Spain
facility: Research Site
city: Hosp de Llobregat(Barcelona)
country: Spain
facility: Research Site
city: Jaén
country: Spain
facility: Research Site
city: La Laguna (Tenerife)
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Lérida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Palma de Mallorca
country: Spain
facility: Research Site
city: Pamplona
country: Spain
facility: Research Site
city: Pozuelo de Alarcon
country: Spain
facility: Research Site
city: Reus,Tarragona
country: Spain
facility: Research Site
city: Sabadell(Barcelona)
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: San Sebastián
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Terrassa(Barcelona)
country: Spain
facility: Research Site
city: Toledo
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Solna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Bristol
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Cardiff.
country: United Kingdom
facility: Research Site
city: Dudley
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
city: Stoke-on-Trent
country: United Kingdom
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Integrated Cancer Centre Guy's Hospital, King's College, London School of Medicine, London, UK
name: Andrew Tutt, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Judy Garber, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Charles Geyer, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.