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NCT03945721: UNITY
A Phase I Study of Niraparib Administered Concurrently With Postoperative RT in Triple Negative Breast Cancer Patients
Active, enrolled
Phase 1
Last updated 29 September 2025
What this trial tests
Phase 1 trial testing Niraparib in Triple Negative Breast Cancer in 21 participants. Participants enrolled and being followed up; not accepting new ones.
Timeline
11 July 2019
Primary endpoint
31 December 2026
31 December 2026
31 December 2028
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 11 July 2019 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2028 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Niraparib (niraparib) — full drug profile →
- Radiation Therapy — full drug profile →
Conditions studied
- Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →
- Residual Disease — all drugs for Residual Disease →
Sponsor
Massachusetts General Hospital
Who can join
18 and older, any sex, with Triple Negative Breast Cancer or Residual Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This research study involves Niraparib as a possible treatment for triple negative breast cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting DNA repair pathway in cancer: Mechanisms and clinical application.
Wang M, Chen S, Ao D. · · 2021 · cited 84× · PMID 34977872 · DOI 10.1002/mco2.103 -
Optimizing Radiation Therapy to Boost Systemic Immune Responses in Breast Cancer: A Critical Review for Breast Radiation Oncologists.
Ho AY, Wright JL, Blitzblau RC, Mutter RW, et al · · 2020 · cited 32× · PMID 32417409 · DOI 10.1016/j.ijrobp.2020.05.011 -
Enhancing anti-tumour innate immunity by targeting the DNA damage response and pattern recognition receptors in combination with radiotherapy.
Chan Wah Hak CML, Rullan A, Patin EC, Pedersen M, et al · · 2022 · cited 27× · PMID 36106115 · DOI 10.3389/fonc.2022.971959 -
PARP Inhibitors in the Treatment of Early Breast Cancer: The Step Beyond?
Gonçalves A, Bertucci A, Bertucci F. · · 2020 · cited 26× · PMID 32471249 · DOI 10.3390/cancers12061378 -
Radiotherapy-induced ferroptosis for cancer treatment.
Beretta GL, Zaffaroni N. · · 2023 · cited 25× · PMID 37388241 · DOI 10.3389/fmolb.2023.1216733 -
Advances in molecular targeted therapies to increase efficacy of (chemo)radiation therapy.
Viktorsson K, Rieckmann T, Fleischmann M, Diefenhardt M, et al · · 2023 · cited 19× · PMID 37041372 · DOI 10.1007/s00066-023-02064-y -
Harnessing DNA Repair Defects to Augment Immune-Based Therapies in Triple-Negative Breast Cancer.
Clark CA, Yang ES. · · 2021 · cited 19× · PMID 34631532 · DOI 10.3389/fonc.2021.703802 -
The My Cancer Genome clinical trial data model and trial curation workflow.
Jain N, Mittendorf KF, Holt M, Lenoue-Newton M, et al · · 2020 · cited 15× · PMID 32483629 · DOI 10.1093/jamia/ocaa066
Verify or expand the search:
- PubMed search for NCT03945721
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Niraparib
Trials testing the same drug.
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- NCT06682780 — A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours · Phase 1, PHASE2 · recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
- NCT06887933 — A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ov · Phase 4 · not yet recruiting
- NCT05672095 — Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer · Phase 1, PHASE2 · withdrawn
Other recruiting trials for Triple Negative Breast Cancer
Currently open trials in the same condition.
- NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H · Phase 3 · recruiting
- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07281976 — A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer · Phase 1, PHASE2 · recruiting
- NCT06225505 — Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE) · NA · recruiting
Other Massachusetts General Hospital trials
Trials by the same sponsor.
- NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
- NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
- NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
- NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
- NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03945721 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 29 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03945721.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing