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

NCT ID: NCT04915755

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Neoplasms, Breast

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)

Eligible participants will receive either Niraparib or Placebo.

Group Type: EXPERIMENTAL

Niraparib

Intervention Type: DRUG

Niraparib will be administered.

Placebo

Intervention Type: DRUG

Matching placebo will be administered

Cohort 2: Participants with tBRCAwt TNBC

Eligible participants will receive either Niraparib or Placebo.

Group Type: EXPERIMENTAL

Niraparib

Intervention Type: DRUG

Niraparib will be administered.

Placebo

Intervention Type: DRUG

Matching placebo will be administered

Interventions

Niraparib

Niraparib will be administered.

Intervention Type: DRUG

Placebo

Matching placebo will be administered

Intervention Type: DRUG

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.
• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Burbank, California, United States

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Duarte, California, United States

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Palo Alto, California, United States

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San Francisco, California, United States

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Aurora, Colorado, United States

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Highlands Ranch, Colorado, United States

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Chicago, Illinois, United States

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Skokie, Illinois, United States

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Ann Arbor, Michigan, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Fargo, North Dakota, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Norfolk, Virginia, United States

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Everett, Washington, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Capital Federal, , Argentina

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Cipoletti Rio Negro, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Ciudad AutOnoma de Buenos Aire, , Argentina

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Ciudad Autonoma de Buenos Aire, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Entre Ríos, , Argentina

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Camperdown, New South Wales, Australia

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Macquarie Park, New South Wales, Australia

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North Sydney, New South Wales, Australia

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Feldkirch, , Austria

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Innsbruck, , Austria

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Steyr, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Brussels, , Belgium

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Charleroi, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Belo Horizonte, , Brazil

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Florianópolis, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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Rio Grande, , Brazil

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Salvador, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Vitória, , Brazil

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Calgary, Alberta, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Santiago, , Chile

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Santiago, , Chile

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Temuco, , Chile

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Helsinki, , Finland

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Helsinki, , Finland

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Turku, , Finland

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Avignon, , France

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Bordeaux, , France

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Caen, , France

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Dijon, , France

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Marseille, , France

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Montpellier, , France

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Pierre-Bénite, , France

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Rouen, , France

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Saint-Cloud, , France

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Berlin, , Germany

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Cologne, , Germany

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Erlangen, , Germany

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Essen, , Germany

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Mannheim, , Germany

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München, , Germany

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Ulm, , Germany

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Debrecen, , Hungary

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Dublin, , Ireland

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Dublin, , Ireland

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Beersheba, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Bologna, , Italy

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Brindisi, , Italy

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Candiolo to, , Italy

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Catania, , Italy

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Genova, , Italy

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Meldola FC, , Italy

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Milan, , Italy

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Milan, , Italy

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Monza, , Italy

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Napoli, , Italy

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Negrar Verona, , Italy

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Padua, , Italy

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Aichi, , Japan

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Chiba, , Japan

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Ehime, , Japan

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Fukuoka, , Japan

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Kanagawa, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Tokyo, , Japan

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León, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Monterrey, , Mexico

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Alkmaar, , Netherlands

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Leeuwarden, , Netherlands

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Maastricht, , Netherlands

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Rotterdam, , Netherlands

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The Hague, , Netherlands

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Zwolle, , Netherlands

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Drammen, , Norway

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Stavanger, , Norway

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Katowice, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Rzeszów, , Poland

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Szczecin, , Poland

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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StPetersburg, , Russia

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Cape Town, , South Africa

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Port Elizabeth, , South Africa

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Pretoria, , South Africa

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Cáceres, , Spain

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Córdoba, , Spain

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Granada, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Santiago de Compostela, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Basel, , Switzerland

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Bath, , United Kingdom

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Brighton, , United Kingdom

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Cardiff, , United Kingdom

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Coventry, , United Kingdom

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Edinburgh, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Maidstone, , United Kingdom

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Manchester, , United Kingdom

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Sutton, , United Kingdom

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Wigan, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Chile; Finland; France; Germany; Hungary; Ireland; Israel; Italy; Japan; Mexico; Netherlands; Norway; Poland; Portugal; Romania; Russia; South Africa; Spain; Switzerland; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-003973-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

213831

Identifier Type: -

Identifier Source: org_study_id