Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Either Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

  • STATUS
    Recruiting
  • End date
    Aug 24, 2029
  • participants needed
    800
  • sponsor
    GlaxoSmithKline
Updated on 29 October 2021
growth factor
endocrine therapy
hormone therapy
HER2
erbb2
epidermal growth factor
adjuvant chemotherapy
her2/neu-negative breast cancer

Summary

This is a multicenter, multi-cohort, phase 3, double-blinded, placebo-controlled study to 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.

Details
Condition Breast Cancer
Treatment Placebo, Niraparib
Clinical Study IdentifierNCT04915755
SponsorGlaxoSmithKline
Last Modified on29 October 2021

Eligibility

Yes No Not Sure

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 tBRCA mutation
Completed prior standard therapy for curative intent including all of the following, if indicated: neoadjuvant treatment, surgery, adjuvant radiotherapy, and adjuvant chemotherapy
Participants with HR+ breast cancer must be on a stable regimen of endocrine therapy, if indicated, for at least 3 months prior to enrollment. Ovarian suppression, if indicated, must also have been started at least 3 months prior to enrollment
Detectable ctDNA as measured by central Signatera 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)

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
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 or radiographic evaluation, in cases where preoperative chemotherapy was administered
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 greater than equal to (>=) 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
Participants have a history of human immunodeficiency virus (HIV) disease
Participants have a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
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