At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Deleterious or suspected deleterious BRCA1 or BRCA2 mutation (germline or somatic)
- ✓HER2-negative breast cancer
- ✓Operable, non-metastatic invasive carcinoma, confirmed by core needle biopsy
- ✕Prior anti-cancer therapies for current malignancy
- ✕Known evidence of distant metastasis
- ✕Known hypersensitivity to niraparib components or formulation excipients
- ✕Major surgery within 3 weeks of starting study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-arm Pilot Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-negative, BRCA-mutant Breast Cancer Patients
In Brief
A Phase 1 clinical trial evaluating Niraparib for Neoplasms, Breast. Completed, enrolled 21 participants.
Detailed Summary
This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in participants with Human epidermal growth factor receptor 2 (HER2)-negative and breast cancer susceptibility gene mutant (BRCAmut) localized breast cancer (primary tumor \>=1 centimeters \[cm\]). Breast magnetic resonance imaging (MRI), breast ultrasound, and tumor core biopsy will be performed at the screening (Days -28 to -1). Participants will receive niraparib (200 milligrams \[mg\] orally \[PO\]) treatment daily for 28 days (Cycle 1) and then will undergo breast ultrasound at the end of Cycle 1 on Day 28. Based on breast ultrasound reports, the participants will either discontinue the study (disease progression) or will continue niraparib treatment (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) for an additional cycle (Cycle 2). A breast MRI and breast ultrasound will be performed at the end of Cycle 2. Approximately 21 participants will be enrolled in this study and the study duration will be approximately 2 years.
Study Details
Timeline
Interventions
Niraparib is a potent, orally active, highly selective poly adenosine diphosphate (\[ADP\]-ribose) polymerase 1 (PARP1) and PARP2 inhibitor. It will be supplied as 100 mg capsules and will be administered at starting dose of 200 mg PO daily throughout 28 days for 2 cycles (each cycle is 28 days), with the potential for an additional 4 cycles (maximum total of 6 cycles) at the assigned dose and schedule.