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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Neoplasms, Breast

In brief

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.

Key facts

Study ID

NCT04915755

Run by

GlaxoSmithKline

People needed

40

Starts

2021-06-28

Expected to finish

2025-12-31

Last updated by the study team

2025-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• GSK Investigational Site — Duarte, California, United States
• GSK Investigational Site — Palo Alto, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Aurora, Colorado, United States
• GSK Investigational Site — Highlands Ranch, Colorado, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Skokie, Illinois, United States
• GSK Investigational Site — Ann Arbor, Michigan, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Fargo, North Dakota, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Sioux Falls, South Dakota, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Fort Worth, Texas, United States
• GSK Investigational Site — Houston, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Tyler, Texas, United States
• GSK Investigational Site — Norfolk, Virginia, United States
• GSK Investigational Site — Everett, Washington, United States
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Burbank, California, United States

Full record on ClinicalTrials.gov

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