Floatz Rating
B57/100
Confidence
Indicative
Sponsor
Canadian Cancer Trials Group
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
56High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05601440CT.gov Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer | — | Recruiting | — | — | — |
NCT05519670CT.gov A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr | — | Not Yet Recruiting | — | — | — |
NCT05238831CT.gov SMMART Adaptive Clinical Treatment (ACT) Trial | — | Withdrawn | — | — | — |
NCT04673448CT.gov Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer | — | Active Not Recruiting | — | — | — |
NCT04991480CT.gov A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors | — | Completed | — | — | — |
NCT04837209CT.gov Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT04915755CT.gov 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 | — | Active Not Recruiting | — | — | — |
NCT04481113CT.gov Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer | — | Completed | — | — | — |
NCT04762901CT.gov LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer | — | Withdrawn | — | — | — |
NCT04584255CT.gov Niraparib + Dostarlimab In BRCA Mutated Breast Cancer | — | Active Not Recruiting | — | — | — |
Show 9 more trialsShow fewer
NCT04655183CT.gov Study of M4344 in Combination With Niraparib | — | Withdrawn | — | — | — |
NCT04240106CT.gov Niraparib Plus Aromatase Inhibitors for Luminal-like(HER2-,ER+) and gBRCA or HDR+ Metastatic Breast Cancer (LUZERN) | — | Completed | — | — | — |
NCT03368729CT.gov Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02826512CT.gov A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients | — | Terminated | — | — | — |
NCT03329937CT.gov Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Participants With Breast Cancer | — | Completed | — | — | — |
NCT03154281CT.gov Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast | — | Completed | — | — | — |
NCT02657889CT.gov Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer | — | Completed | — | — | — |
NCT01905592CT.gov A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients | — | Terminated | — | — | — |
NCT01042379CT.gov I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer | — | Recruiting | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Niraparib (this asset) | Canadian Cancer Trials Group | P3 | B · 57 |
| Darolutamide | Vandana Abramson | P2 | BBB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Palbociclib | Hoffmann-La Roche | P4 | BB |
| Trastuzumab Duocarmazine | Byondis B.V. | P3 | BB |
| Goserelin | TerSera Therapeutics LLC | P4 | BB |
| Ribociclib | National Cancer Institute (NCI) | P4 | BB |
| Oxaliplatin | Beijing Biostar Pharmaceuticals Co., Ltd. | P4 | BB |
| Eribulin Monomethanesulfonate | Henan Cancer Hospital | P4 | BB |
+42 more in the Breast Cancer cohort
Other indications for Niraparib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Carcinoma | — | P3 | BB · 67 |
| Ovarian Carcinoma | — | P4 | BB · 66 |
| Ovarian Neoplasm | — | P4 | BB · 66 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Niraparib in Breast Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/niraparib-breast-cancer
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