Breast Cancer Clinical Trial
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
Summary
This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy. Participants who have completed definitive therapy at any time in the past are eligible for ctDNA monitoring and potential enrollment onto the trial.
Eligibility Criteria
Inclusion Criteria:
Stage I to III breast cancer with surgical resection of the primary tumor that is confirmed to be either: TNBC, irrespective of BRCA status or HR+/HER2- breast cancer with a known and documented deleterious or suspected deleterious tBRCA mutation.
Completed prior standard therapy for curative intent.
Participants with HR+ breast cancer must be on a stable regimen of endocrine therapy.
Detectable ctDNA as measured by central testing.
An archival tumor tissue specimen of the primary tumor sufficient in quality and quantity for ctDNA assay design and tBRCA and Homologous recombination deficiency (HRD) testing is required.
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
Prior treatment with a Poly Adenosine-diphosphate Ribose Polymerase (PARP) inhibitor.
Current treatment with a Cyclin-dependent kinase (CDK)4/6 inhibitor or endocrine therapy other than anastrozole, letrozole, exemestane, and tamoxifen with or without ovarian suppression.
Participants have any sign of metastasis or local recurrence after comprehensive assessment conducted per protocol.
Participants have shown no definitive response to preoperative chemotherapy by pathologic, radiographic or clinical evaluation, in cases where preoperative chemotherapy was administered.
Participants have inadequately treated or controlled hypertension.
Participants have received live vaccine within 30 days of planned start of study randomization.
Participants have a second primary malignancy. Exceptions are the following: (a) Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal carcinoma in situ (DCIS) of the breast, Stage I Grade 1 endometrial carcinoma. (b) Other solid tumors and lymphomas (without bone marrow involvement) diagnosed >=5 years prior to randomization and treated with no evidence of disease recurrence and for whom no more than 1 line of chemotherapy was applied.
Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment.
Participant is immunocompromised. Participants with splenectomy are allowed. Participants with known human immunodeficiency virus (HIV) are allowed if they meet protocol-defined criteria.
Participants have a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
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There are 196 Locations for this study
Burbank California, 91505, United States More Info
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Duarte California, 91010, United States More Info
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Orange California, 92868, United States More Info
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Palo Alto California, 94304, United States More Info
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Aurora Colorado, 80045, United States More Info
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Chicago Illinois, 60612, United States More Info
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Skokie Illinois, 60076, United States More Info
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Ann Arbor Michigan, 48109, United States More Info
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Albuquerque New Mexico, 87106, United States More Info
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New York New York, 10032, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Philadelphia Pennsylvania, 19111, United States More Info
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Pittsburgh Pennsylvania, 15213, United States More Info
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Sioux Falls South Dakota, 57104, United States More Info
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Austin Texas, 78731, United States More Info
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Dallas Texas, 75231, United States More Info
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Dallas Texas, 75246, United States More Info
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Fort Worth Texas, 76104, United States More Info
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Houston Texas, 77024, United States More Info
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San Antonio Texas, 78240, United States More Info
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Tyler Texas, 75702, United States More Info
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Norfolk Virginia, 23502, United States More Info
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Everett Washington, 98201, United States More Info
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Capital Federal Buenos Aires, C1426, Argentina More Info
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Ciudad Autonoma Buenos Aires Buenos Aires, C1430, Argentina More Info
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Ciudad Autónoma de Buenos Aires Buenos Aires, C1125, Argentina More Info
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Gualeguaychu Entre RÃos, 2822, Argentina More Info
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Cipoletti, Rio Negro RÃo Negro, R8324, Argentina More Info
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Capital Federal, Buenos Aires , C1118, Argentina More Info
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Ciudad Autonoma Buenos Aires , C1015, Argentina More Info
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Ciudad Autonoma de Buenos Aires , C1017, Argentina More Info
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Ciudad Autonoma de Buenos Aires , C1426, Argentina More Info
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Ciudad Autónoma de Buenos Aires , C1426, Argentina More Info
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Camperdown New South Wales, 2050, Australia More Info
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Macquarie University New South Wales, 2109, Australia More Info
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North Sydney New South Wales, 2060, Australia More Info
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Steyr , 4400, Austria More Info
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Bruxelles , 1070, Belgium More Info
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Ondina Bahia, 40170, Brazil More Info
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Vitória EspÃrito Santo, 29043, Brazil More Info
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Belo Horizonte Minas Gerais, 30130, Brazil More Info
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Caxias do Sul Rio Grande Do Sul, 95070, Brazil More Info
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Porto Alegre Rio Grande Do Sul, 90020, Brazil More Info
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Porto Alegre Rio Grande Do Sul, 90610, Brazil More Info
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Florianopolis Santa Catarina, 88034, Brazil More Info
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Rio de Janeiro , 20560, Brazil More Info
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Calgary Alberta, T2N 4, Canada More Info
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Toronto Ontario, M4N 3, Canada More Info
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Toronto Ontario, M5G 2, Canada More Info
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Montreal Quebec, H3T 1, Canada More Info
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Providencia Región Metro De Santiago, 75006, Chile More Info
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Santiago Región Metro De Santiago, 75008, Chile More Info
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Santiago Región Metro De Santiago, 83200, Chile More Info
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Avignon Cedex 9 , 84918, France More Info
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Bordeaux Cedex , 33076, France More Info
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Clermont-Ferrand cedex , 63011, France More Info
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Marseille Cedex 20 , 13915, France More Info
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Montpellier , 34070, France More Info
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Pierre-Bénite cedex , 69495, France More Info
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Saint-Cloud , 92210, France More Info
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Mannheim Baden-Wuerttemberg, 68167, Germany More Info
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Ulm Baden-Wuerttemberg, 89075, Germany More Info
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Erlangen Bayern, 91054, Germany More Info
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Muenchen Bayern, 81377, Germany More Info
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Offenbach Hessen, 63069, Germany More Info
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Duesseldorf Nordrhein-Westfalen, 40225, Germany More Info
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Essen Nordrhein-Westfalen, 45136, Germany More Info
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Koeln Nordrhein-Westfalen, 50935, Germany More Info
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Beer Sheva , 84101, Israel More Info
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Petach Tikva , 49100, Israel More Info
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Napoli Campania, 80131, Italy More Info
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Bologna Emilia-Romagna, 40138, Italy More Info
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Meldola (FC) Emilia-Romagna, 47014, Italy More Info
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Aviano (PN) Friuli-Venezia-Giulia, 33081, Italy More Info
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Genova Liguria, 16132, Italy More Info
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Cremona Lombardia, 26100, Italy More Info
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Milano Lombardia, 20141, Italy More Info
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Milano Lombardia, 20157, Italy More Info
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Monza (MB) Lombardia, 20900, Italy More Info
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Torrette Di Ancona Marche, 60126, Italy More Info
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Candiolo Piemonte, 10060, Italy More Info
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Brindisi Puglia, 72100, Italy More Info
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Catania Sicilia, 95122, Italy More Info
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Negrar (Verona) Veneto, 37024, Italy More Info
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Padova Veneto, 35128, Italy More Info
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Kanagawa , 241-8, Japan More Info
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León, Guanajuato Guanajuato, 37000, Mexico More Info
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Monterrey Nuevo León, 64460, Mexico More Info
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Monterrey Nuevo León, 66278, Mexico More Info
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Ciudad de Mexico , 04980, Mexico More Info
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Alkmaar , 1815 , Netherlands More Info
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Den Haag , 2545 , Netherlands More Info
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Leeuwarden , 8934 , Netherlands More Info
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Maastricht , 6229 , Netherlands More Info
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Rotterdam , 3083 , Netherlands More Info
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Zwolle , 8025 , Netherlands More Info
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Drammen , N-300, Norway More Info
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Krakow , 31-11, Poland More Info
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Loures , 2674-, Portugal More Info
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Bucharest , 01117, Romania More Info
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Cumparatura , 72704, Romania More Info
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Timisoara , 30023, Romania More Info
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Arkhangelsk , 16304, Russian Federation More Info
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Chelyabinsk , 45404, Russian Federation More Info
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Moscow , 11112, Russian Federation More Info
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Moscow , 12130, Russian Federation More Info
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Moscow , 14342, Russian Federation More Info
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Omsk , 64401, Russian Federation More Info
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Pushkin , 19660, Russian Federation More Info
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Ryazan , 39001, Russian Federation More Info
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Saint Petersburg , 19711, Russian Federation More Info
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Saint-Petersburg , 19401, Russian Federation More Info
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St. Petersburg , 19775, Russian Federation More Info
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St.Peterburg , 19702, Russian Federation More Info
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Kraaifontein Western Province, 7570, South Africa More Info
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Cape Town , 7700, South Africa More Info
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Port Elizabeth , 6045, South Africa More Info
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Pretoria , 0041, South Africa More Info
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Barcelona , 08003, Spain More Info
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Barcelona , 08028, Spain More Info
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Barcelona , 08035, Spain More Info
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Cáceres , 10003, Spain More Info
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Córdoba , 14004, Spain More Info
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Granada , 18016, Spain More Info
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Madrid , 28034, Spain More Info
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Madrid , 28050, Spain More Info
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Majadahonda (Madrid) , 28222, Spain More Info
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Murcia , 30008, Spain More Info
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Málaga , 29010, Spain More Info
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Santiago de Compostela , 15706, Spain More Info
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Valencia , 46010, Spain More Info
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Basel , 4031, Switzerland More Info
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Sutton Surrey, SM2 5, United Kingdom More Info
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Coventry Warwickshire, CV2 2, United Kingdom More Info
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Bath , BA1 3, United Kingdom More Info
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Brighton , BN2 5, United Kingdom More Info
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Cardiff , CF14 , United Kingdom More Info
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Edinburgh , EH4 2, United Kingdom More Info
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Leeds , LS9 7, United Kingdom More Info
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London , SE1 9, United Kingdom More Info
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London , SW3 6, United Kingdom More Info
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Maidstone , ME16 , United Kingdom More Info
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Manchester , M20 4, United Kingdom More Info
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Wigan. , WN1 2, United Kingdom More Info
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