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NCT04041128

PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer

Completed EARLY_PHASE1 Last updated 20 March 2023
What this trial tests

EARLY_PHASE1 trial testing Lynparza in Ovarian Cancer in 14 participants. Completed in 15 June 2021.

Timeline
23 July 2019
Primary endpoint
15 June 2021
15 June 2021

Quick facts

Lead sponsorUniversity of Texas Southwestern Medical Center
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment14
Start date23 July 2019
Primary completion15 June 2021
Estimated completion15 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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:

Other trials of Lynparza

Trials testing the same drug.

Other recruiting trials for Ovarian Cancer

Currently open trials in the same condition.

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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