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

NCT04915755 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 2 other identifiers: 2138312020-003973-23
• Study Type: interventional
• Target: 40
• Locations: 26 countries
• Sites: 194

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

Keywords

Niraparib; Breast cancer susceptibility gene; Human epidermal growth factor-2 negative (HER2); Breast cancer; Triple negative breast cancer (TNBC); Circulating tumor Deoxyribonucleic acid (ctDNA)

Outcome Measures

Primary Outcomes (8)

• Number of Participants With Treatment Emergent Adverse Event (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

  An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AESI is any AE (serious or nonserious) that is of scientific and medical concern specific to niraparib for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is warranted. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

  Up to approximately 125 weeks

• Number of Participants With TEAEs Leading to Death

  An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state.Number of participants with TEAEs leading to death were reported.

  Up to approximately 125 weeks

• Number of Participants With TEAEs Leading to Dose Modifications and Discontinuation of Study Treatment

  An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. Number of participants with TEAEs leading to dose modifications (reduction and interruption/delay) and permanent discontinuation of study treatment were reported.

  Up to approximately 125 weeks

• Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

  Number of participants with ECOG Performance Status was reported and was measured on 6-point grade scale 0: Fully active, able to carry on all pre-disease performance without restriction. Grade 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of light or sedentary nature; Grade 2 - Ambulatory \& capable of all self-care but unable to carry out any work activities. Up and about more than (\>) 50% of waking hours; Grade 3 -Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4 -Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5 -Dead. Data is presented as baseline grade, best case on-therapy, and worst-case on-therapy for the available participants.

  Up to approximately 125 weeks

• Number of Participants With Worst-Case Post-Baseline (WCPB) Hematology Results Relative to Baseline

  Blood samples were collected for the analysis of hematology parameters. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest non-missing pre-dose value, including those from unscheduled visits.

  Up to approximately 125 weeks

• Number of Participants With Worst-Case Post-Baseline (WCPB) Clinical Chemistry Results Relative to Baseline

  Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Baseline is defined as the latest non-missing pre-dose value, including those from unscheduled visits.

  Up to approximately 125 weeks

• Number of Participants With Worst-Case Post-Baseline (WCPB) Vital Signs Results Relative to Baseline

  The abnormal vital sign ranges are: Pulse Rate (PR): Low \[\<60 beats per minute (bpm)\], Normal (60 bpm to 100 bpm), High (\>100 bpm); Temperature: Low (\<35 degree Celsius (°C)), Normal (35 C and 38 C), High (\>38 C); Systolic Blood Pressure (SBP): Low (\<90 millimeter of mercury (mmHg)), Normal (\>90 mmHg to \<120 mmHg), High (\>120 mmHg); Diastolic Blood Pressure (DBP): Low (\<60 mmHg), Normal (60 mmHg to 79 mmHg), High (\>80 mmHg). Participants were counted in the maximum worst case increase category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the "To Normal or No Change" category.

  Up to approximately 125 weeks

• Number of Participants With Use of Concomitant Medications

  Number of participants who used concomitant medications is presented.

  Up to approximately 125 weeks

Study Arms (2)

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

EXPERIMENTAL

Eligible participants will receive either Niraparib or Placebo.

Drug: Niraparib; Drug: Placebo

Cohort 2: Participants with tBRCAwt TNBC

EXPERIMENTAL

Eligible participants will receive either Niraparib or Placebo.

Drug: Niraparib; Drug: Placebo

Interventions

Niraparib DRUG

Niraparib will be administered.

Cohort 2: Participants with tBRCAwt TNBC; Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)

Placebo DRUG

Matching placebo will be administered

Cohort 2: Participants with tBRCAwt TNBC; Cohort1:Participants with tBRCAmut HER2-breast cancer(Independent of HR status,including HR+andTNBC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (198)

GSK Investigational Site

Burbank, California, 91505, United States

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GSK Investigational Site

Duarte, California, 91010, United States

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GSK Investigational Site

Palo Alto, California, 94304, United States

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GSK Investigational Site

San Francisco, California, 94158, United States

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GSK Investigational Site

Aurora, Colorado, 80045, United States

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Highlands Ranch, Colorado, 80045, United States

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GSK Investigational Site

Chicago, Illinois, 60612, United States

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Skokie, Illinois, 60076, United States

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Ann Arbor, Michigan, 48109, United States

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Albuquerque, New Mexico, 87106, United States

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New York, New York, 10032, United States

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Fargo, North Dakota, 58122, United States

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Philadelphia, Pennsylvania, 19111, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Sioux Falls, South Dakota, 57104, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75231, United States

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GSK Investigational Site

Dallas, Texas, 75246, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77024, United States

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San Antonio, Texas, 78240, United States

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Tyler, Texas, 75702, United States

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Norfolk, Virginia, 23502, United States

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Everett, Washington, 98201, United States

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Buenos Aires, C1017 AAS, Argentina

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Buenos Aires, C1125ABD, Argentina

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Buenos Aires, C1426ABP, Argentina

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Capital Federal, C1426ANZ, Argentina

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Cipoletti Rio Negro, R8324CVE, Argentina

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Ciudad Autonoma Buenos Aires, C1430EGF, Argentina

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Ciudad AutOnoma de Buenos Aire, C1015ABO, Argentina

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Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina

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Ciudad de Buenos Aires, C1118AAT, Argentina

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Entre Ríos, 2822, Argentina

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Camperdown, New South Wales, 2050, Australia

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Macquarie Park, New South Wales, 2109, Australia

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North Sydney, New South Wales, 2060, Australia

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Feldkirch, A-6830, Austria

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Innsbruck, 6020, Austria

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GSK Investigational Site

Steyr, 4400, Austria

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Vienna, A-1090, Austria

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Brussels, 1070, Belgium

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GSK Investigational Site

Brussels, 1200, Belgium

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Charleroi, 6000, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Belo Horizonte, 30130-100, Brazil

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GSK Investigational Site

Florianópolis, 88034-000, Brazil

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GSK Investigational Site

Porto Alegre, 90020-090, Brazil

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GSK Investigational Site

Porto Alegre, 90610000, Brazil

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GSK Investigational Site

Rio de Janeiro, 20560-120, Brazil

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GSK Investigational Site

Rio Grande, 95070-560, Brazil

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GSK Investigational Site

Salvador, 40170-110, Brazil

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GSK Investigational Site

São Paulo, 01317000, Brazil

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São Paulo, 04312903, Brazil

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GSK Investigational Site

Vitória, 29043-260, Brazil

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GSK Investigational Site

Calgary, Alberta, T2N 4N2, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1S 4L8, Canada

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GSK Investigational Site

Santiago, 7500653, Chile

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GSK Investigational Site

Santiago, 7500836, Chile

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GSK Investigational Site

Temuco, 5360000, Chile

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GSK Investigational Site

Helsinki, 00180, Finland

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GSK Investigational Site

Helsinki, HUS 00029, Finland

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GSK Investigational Site

Turku, 20520, Finland

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GSK Investigational Site

Avignon, 84918, France

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Bordeaux, 33076, France

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Caen, 14000, France

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Dijon, 21000, France

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Marseille, 13915, France

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GSK Investigational Site

Montpellier, 34070, France

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GSK Investigational Site

Pierre-Bénite, 69495, France

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GSK Investigational Site

Rouen, 76000, France

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Saint-Cloud, 92210, France

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GSK Investigational Site

Berlin, 13125, Germany

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Cologne, 50935, Germany

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GSK Investigational Site

Erlangen, 91054, Germany

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Essen, 45136, Germany

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GSK Investigational Site

Mannheim, 68167, Germany

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München, 81377, Germany

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Ulm, 89075, Germany

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GSK Investigational Site

Debrecen, 4032, Hungary

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GSK Investigational Site

Dublin, 8, Ireland

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Dublin, 9, Ireland

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GSK Investigational Site

Beersheba, 84101, Israel

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GSK Investigational Site

Haifa, 31096, Israel

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GSK Investigational Site

Jerusalem, 91031, Israel

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Jerusalem, 91120, Israel

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Petah Tikva, 49100, Israel

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Rehovot, 76100, Israel

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GSK Investigational Site

Tel Aviv, 64239, Israel

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Ancona, 60126, Italy

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Ancona, 62100, Italy

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Bologna, 40138, Italy

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Brindisi, 72100, Italy

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GSK Investigational Site

Candiolo to, 10060, Italy

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GSK Investigational Site

Catania, 95122, Italy

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Genova, 16132, Italy

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GSK Investigational Site

Meldola FC, 47014, Italy

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GSK Investigational Site

Milan, 20141, Italy

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Milan, 20157, Italy

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Monza, 20900, Italy

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Napoli, 80131, Italy

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Negrar Verona, 37024, Italy

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GSK Investigational Site

Padua, 35128, Italy

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GSK Investigational Site

Aichi, 464-8681, Japan

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GSK Investigational Site

Chiba, 277-8577, Japan

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GSK Investigational Site

Ehime, 791-0280, Japan

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Fukuoka, 811-1395, Japan

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Hiroshima, 730-8518, Japan

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Hokkaido, 003-0804, Japan

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GSK Investigational Site

Kagoshima, 892-0833, Japan

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Kanagawa, 216-8511, Japan

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GSK Investigational Site

Kanagawa, 241-8515, Japan

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Kanagawa, 259-1143, Japan

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GSK Investigational Site

Okayama, 700-8558, Japan

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GSK Investigational Site

Osaka, 541-8567, Japan

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GSK Investigational Site

Osaka, 589-8511, Japan

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GSK Investigational Site

Saitama, 350-1298, Japan

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GSK Investigational Site

Saitama, 350-8550, Japan

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GSK Investigational Site

Saitama, 362-0806, Japan

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GSK Investigational Site

Tokyo, 104-0045, Japan

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GSK Investigational Site

Tokyo, 113-8431, Japan

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GSK Investigational Site

Tokyo, 135-8550, Japan

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GSK Investigational Site

Tokyo, 142-8666, Japan

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GSK Investigational Site

León, 37178, Mexico

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GSK Investigational Site

Mexico City, 04980, Mexico

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GSK Investigational Site

Monterrey, 64460, Mexico

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GSK Investigational Site

Monterrey, 66278, Mexico

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GSK Investigational Site

Alkmaar, 1815 JD, Netherlands

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GSK Investigational Site

Leeuwarden, 8934 AD, Netherlands

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Maastricht, 6229 HX, Netherlands

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Rotterdam, 3083 AN, Netherlands

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The Hague, 2545 AA, Netherlands

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GSK Investigational Site

Zwolle, 8025 AB, Netherlands

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GSK Investigational Site

Drammen, N-3004, Norway

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GSK Investigational Site

Stavanger, 4011, Norway

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GSK Investigational Site

Katowice, 40-514, Poland

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Krakow, 31-115, Poland

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GSK Investigational Site

Krakow, 31-501, Poland

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GSK Investigational Site

Olsztyn, 10-228, Poland

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Poznan, 61-866, Poland

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GSK Investigational Site

Rzeszów, 35-021, Poland

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GSK Investigational Site

Siedlce, 08-110, Poland

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GSK Investigational Site

Szczecin, 70-707, Poland

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GSK Investigational Site

Warsaw, 02-781, Poland

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GSK Investigational Site

Wroclaw, 53-413, Poland

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GSK Investigational Site

Lisbon, 1649-035, Portugal

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GSK Investigational Site

Loures, 2674-514, Portugal

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GSK Investigational Site

Bucharest, 011171, Romania

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GSK Investigational Site

Bucharest, 020142, Romania

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GSK Investigational Site

Bucharest, 021389, Romania

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GSK Investigational Site

Bucharest, 022343, Romania

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GSK Investigational Site

Cluj-Napoca, 400015, Romania

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GSK Investigational Site

Craiova, 200347, Romania

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GSK Investigational Site

Otopeni, 075100, Romania

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GSK Investigational Site

Timișoara, 300239, Romania

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GSK Investigational Site

Chelyabinsk, 454048, Russia

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GSK Investigational Site

Moscow, 111123, Russia

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GSK Investigational Site

Moscow, 121309, Russia

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GSK Investigational Site

Moscow, 143422, Russia

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GSK Investigational Site

Omsk, 644013, Russia

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GSK Investigational Site

Pushkin, 196603, Russia

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GSK Investigational Site

Saint Petersburg, 197110, Russia

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GSK Investigational Site

Saint Petersburg, 197758, Russia

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GSK Investigational Site

StPetersburg, 197022, Russia

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GSK Investigational Site

Cape Town, 7700, South Africa

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GSK Investigational Site

Port Elizabeth, 6045, South Africa

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GSK Investigational Site

Pretoria, 0041, South Africa

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GSK Investigational Site

Barcelona, 08003, Spain

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GSK Investigational Site

Barcelona, 08028, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Cáceres, 10003, Spain

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GSK Investigational Site

Córdoba, 14004, Spain

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GSK Investigational Site

Granada, 18016, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Madrid, 28050, Spain

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GSK Investigational Site

Málaga, 29010, Spain

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GSK Investigational Site

Santiago de Compostela, 15706, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Zaragoza, 50009, Spain

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Basel, 4031, Switzerland

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Bath, BA1 3NG, United Kingdom

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Brighton, BN2 5BE, United Kingdom

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Cardiff, CF14 2TL, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Leeds, LS9 7TF, United Kingdom

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GSK Investigational Site

London, SE1 9RT, United Kingdom

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GSK Investigational Site

London, SW3 6JJ, United Kingdom

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Maidstone, ME16 9QQ, United Kingdom

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GSK Investigational Site

Manchester, M20 4BX, United Kingdom

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GSK Investigational Site

Sutton, SM2 5PT, United Kingdom

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GSK Investigational Site

Wigan, WN1 2NN, United Kingdom

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MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: June 28, 2021
• Primary Completion: June 28, 2024
• Study Completion: December 31, 2025
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

JP (20); AU (3); IT (14); ME (4); NL (6); PL (10); IL (7); PT (2); ES (14); FR (9); BE (5); CH (1); BR (10); AR (10); GB (12); RO (8); IE (2); RU (9); NO (2); ZA (3); HU (1); CA (5); FI (3); DE (7); US (24); CL (3)