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PARP Inhibition During Pre-surgical Window in Breast/Ovary Cancer | Clinical Trials | Clareo Health

COMPLETEDEARLY_PHASE1

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

Pre-Surgical Window Pilot Investigation of the Effect of PARP Inhibition on the Cellular and Molecular Changes in Primary Ovarian and Breast Cancer

NCT04041128•University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 99 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•All patients must have cytology/ biopsy proven diagnosis of a mullerian carcinoma, high clinical index of suspicion for ovarian cancer OR triple negative, BRCA mutated breast cancer.
•Patients may not have received prior treatment for breast or ovarian cancer.
•All patients must be of at least 18 years of age.
•ECOG Performance status must be 0,1 or 2.
•Patients must not have received a prior PARP inhibitor
•Adequate organ and marrow function as defined below:
•absolute neutrophil count \>/= 1500/mcL
•Platelets \> /= 100,000 /mcl
•Hemoglobin \>/= 8 g/dl
•Total bilirubin \</= 1.5 x the institutional ULN
+8 more criteria

Exclusion Criteria

•Chemotherapy, radiotherapy, or other cancer therapy within 4 weeks prior to starting study treatment. Subjects must have recovered from prior treatment-related to toxicities to grade 1 or baseline (excluding alopecia and clinically stable toxicities requiring ongoing medical management, such as hypothyroidism from prior immune checkpoint inhibitor treatment).
•Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
•Brain metastases
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to Lynparza or other agents used in study.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
•Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

July 23, 2019

Primary Completion Date

June 15, 2021

Completion Date

June 15, 2021

Last Updated

March 20, 2023

Enrollment

ACTUAL participants

Conditions

Ovarian CancerBreast Cancer

Interventions

Lynparza

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer