Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, i...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04915755
Start Date
June 28 2021
End Date
December 31 2025
Last Update
July 16 2025
Active Locations (198)
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1
GSK Investigational Site
Burbank, California, United States, 91505
2
GSK Investigational Site
Duarte, California, United States, 91010
3
GSK Investigational Site
Palo Alto, California, United States, 94304
4
GSK Investigational Site
San Francisco, California, United States, 94158