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This study compares the drug Niraparib with a placebo for effectiveness and safety in people with HER2-negative, BRCA-mutated breast cancer or triple-negative breast cancer (TNBC). Patients who have had their primary tumor surgically removed, completed standard therapy, and have detectable ctDNA could take part. It is a Phase 3 study that is currently not recruiting but is still ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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).