Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT03911453
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    Patients will be treated with single agent rucaparib for 3wks and then proceed to surgery. Core-biopsies (at the time of diagnosis) and tumor from the surgical resection will be assessed for change in expression of PD-L1 by Immunohistochemical assay (IHC).

Study Details

This is a single arm window of opportunity trial conducted in patients with early stage triple negative breast tumors to evaluate if treatment with a Poly(ADP-ribose) polymerase (PARP) inhibitor will increase expression of programmed cell death-1 with ligand (PD-L1) in triple negative breast tumors.

Key Dates

Start date
Apr 19, 2019
Status verified
Oct 2024
Primary completion
Jul 16, 2021
Completion
Jul 16, 2021

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (rucaparib)
    Patients will be treated with single agent rucaparib for 3wks and then proceed to surgery. Core-biopsies (at the time of diagnosis) and tumor from the surgical resection will be assessed for change in expression of programmed cell death-1 with ligand (PD-L1) by immunohistochemistry (IHC) . Starting Dose 600 mg twice daily Dose Level -1 500 mg twice daily Dose Level -2 400 mg twice daily Dose Level -3 300 mg twice daily

Primary Outcome Measure

Measurement of expression of PD-L1 by IHC via core biopsy. [ Time Frame: Six months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Arizona Cancer Center· Tucson, AZ

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