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NCT04041128
PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer
EARLY_PHASE1 trial testing Lynparza in Ovarian Cancer in 14 participants. Completed in 15 June 2021.
15 June 2021
Quick facts
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 14 |
| Start date | 23 July 2019 |
| Primary completion | 15 June 2021 |
| Estimated completion | 15 June 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lynparza — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
University of Texas Southwestern Medical Center
Who can join
Adults 18 to 99, female only, with Ovarian Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study involves surgery for cytoreduction or laparoscopy to determine if you are a candidate for tumor debulking or a tissue biopsy. Following this surgery you will receive chemotherapy. This study will administer 7 days of treatment with a targeted therapy called Lynparza. Lynparza and/or other PARP inhibitors have been FDA approved for the treatment of ovarian and breast cancer. Tissue biopsy will be done before a 7 day course of Lynparza in order to correlate molecular changes to response to treatment. Participation in this trial will require an additional tumor biopsy which will occur either before or after treatment of Lynparza.
Publications & conference data
5 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 -
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 -
DNA Methylation Malleability and Dysregulation in Cancer Progression: Understanding the Role of PARP1.
Srivastava R, Srivastava R, Lodhi N. · · 2022 · cited 15× · PMID 35327610 · DOI 10.3390/biom12030417 -
Advances in predicting breast cancer driver mutations: Tools for precision oncology (Review).
Hao W, Rajendran BK, Cui T, Sun J, et al · · 2025 · cited 3× · PMID 39450552 · DOI 10.3892/ijmm.2024.5447 -
Saying "Yes" to NONO: A Therapeutic Target for Neuroblastoma and Beyond.
Pogodaeva SS, Miletina OO, Antipova NV, Shtil AA, et al · · 2025 · cited 2× · PMID 41097754 · DOI 10.3390/cancers17193228
Verify or expand the search:
- PubMed search for NCT04041128
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lynparza
Trials testing the same drug.
- NCT05081765 — The Effect of Glucose Level and Diabetes Mellitus on Ctrough of Olaparib · unknown
Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
- NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
- NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
- NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other University of Texas Southwestern Medical Center trials
Trials by the same sponsor.
- NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
- NCT06917183 — Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB) · NA · not yet recruiting
- NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
- NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
- NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · 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)
- Trial protocol + status: ClinicalTrials.gov NCT04041128 (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 University of Texas Southwestern Medical Center
- Last refreshed: 20 March 2023
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/NCT04041128.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing