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Активно (без набиране) Фаза 3 NCT04915755

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Neoplasms, Breast

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
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.
Кой може да участва
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. * Estrogen receptor (ER) and/or progesterone receptor (PgR) negativity is defined as immunohistochemistry (IHC) nuclear staining less than (\<) 1 percentage (%), or by Allred scoring system where TNBC is defined to be 0 out of 8 or 2 out of 8, or staining in \<1 % of cancer cells. * 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 (except France). * 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).
Места на провеждане 25
Argentina (1)
GSK Investigational Site
Buenos Aires
Австралия (1)
GSK Investigational Site
Camperdown , New South Wales
Белгия (1)
GSK Investigational Site
Brussels
Бразилия (1)
GSK Investigational Site
Belo Horizonte
Канада (1)
GSK Investigational Site
Calgary , Alberta
Chile (1)
GSK Investigational Site
Santiago
Финландия (1)
GSK Investigational Site
Helsinki
Франция (1)
GSK Investigational Site
Avignon
Германия (1)
GSK Investigational Site
Berlin
Унгария (1)
GSK Investigational Site
Debrecen
Ireland (1)
GSK Investigational Site
Dublin
Израел (1)
GSK Investigational Site
Beersheba
Италия (1)
GSK Investigational Site
Ancona
Япония (1)
GSK Investigational Site
Aichi
Mexico (1)
GSK Investigational Site
León
Нидерландия (1)
GSK Investigational Site
Alkmaar
Норвегия (1)
GSK Investigational Site
Drammen
Полша (1)
GSK Investigational Site
Katowice
Румъния (1)
GSK Investigational Site
Bucharest
Russia (1)
GSK Investigational Site
Chelyabinsk
South Africa (1)
GSK Investigational Site
Cape Town
Испания (1)
GSK Investigational Site
Barcelona
Швейцария (1)
GSK Investigational Site
Basel
Великобритания (1)
GSK Investigational Site
Bath
САЩ (1)
GSK Investigational Site
Burbank , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.06.2021
Крайна дата
31.12.2025
Регистрационен номер
NCT04915755
Източник
anzctr
Запитване за медицински туризъм

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