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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Zejula (niraparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Niraparib for Advanced Breast Cancer with Germline BRCA1 and BRCA2 Mutations: the EORTC 1307-BCG/BIG5–13/TESARO PR-30–50–10-C BRAVO Study
Published date:
07/22/2021
Excerpt:
BRAVO was a randomized, open-label phase III trial. Eligible patients had gBRCAm and HER2-negative advanced breast cancer...PFS was 4.1 months in the niraparib arm (n = 141) versus 3.1 months in the PC arm...ORR was 35% (95% CI, 26–45) with niraparib and 31% (95% CI, 19–46) in the PC arm.
DOI:
10.1158/1078-0432.CCR-21-0310
Trial ID:
Excerpt:
ZEJULA is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated:...for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:...a deleterious or suspected deleterious BRCA mutation...
Source:
Title:
Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN)
Excerpt:
...[Cohort A]: Patients with documented germinal mutation in BRCA1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)....
Trial ID:
Source:
Title:
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Excerpt:
...Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation....
Trial ID:
More C2 evidence
Source:
Title:
A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients
Excerpt:
...- Only the following patients may be referred for BRCA1-like testing: all patients that had triple negative primary breast cancer; hormone-receptor positive, HER2-negative primary breast cancer patients with a histological grade III breast cancer; Breast cancer patients carrying a BRCA1 and/or BRCA2 germ line mutation....
Trial ID:
Source:
Title:
Clinical Trial to evaluate the efficacy and safety of Niraparib + Endocrin Therapy in luminal metastatic breast cancer patients. Ensayo clínico para evaluar la eficacia y seguridad de Niraparib + Terapia endocrina en pacientes luminales con cáncer de mama metastásico.
Excerpt:
...[Cohort A]: Patients with documented germinal mutation in BRCA1 or BRCA2 genes Germinal BRCA assays carried out prior to enrollment will be accepted. ...
Trial ID:
Source:
Title:
Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer
Excerpt:
...- Participants with a deleterious or suspected deleterious breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation (germline or somatic) may be enrolled into the study based on either local or central laboratory testing of BRCA status....
Trial ID:
Less C2 evidence
Source:
Title:
Neoadjuvant study of niraparib in patients with HER2-negative, BRCA-mutated, resectable breast cancer
Published date:
07/04/2022
Excerpt:
After 2 cycles, tumor response (≥30% reduction from baseline) by MRI was 90.5% and 40.0% (6 of 15) of patients who received only niraparib (2–6 cycles) had pathological complete response...In this pilot study, single-agent neoadjuvant niraparib demonstrated promising antitumor activity and high levels of tumor penetration in HER2-negative, BRCA-mut, localized BC.
DOI:
10.1038/s43018-022-00400-2
