Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors
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ClinicalTrials.gov Identifier: NCT03911453 |
Recruitment Status :
Recruiting
First Posted : April 11, 2019
Last Update Posted : February 17, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Rucaparib | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Window of Opportunity Trial to Evaluate Change in PD-L1 Expression in Triple Negative Breast Tumors in Response to the PARP Inhibitor Rucaparib |
Actual Study Start Date : | April 19, 2019 |
Estimated Primary Completion Date : | November 30, 2021 |
Estimated Study Completion Date : | November 30, 2021 |

Arm | Intervention/treatment |
---|---|
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 |
Drug: 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 PD-L1 by Immunohistochemical assay (IHC). |
- Measurement of expression of PD-L1 by IHC via core biopsy. [ Time Frame: Six months ]To evaluate change in expression of programmed cell death-1 with ligand (PD-L1) by Immunohistochemistry (IHC) of tissue sample via core biopsy after treatment with single agent PARPi (rucaparib).
- Measure change in expression of Ki67 by IHC after treatment with PARPi. [ Time Frame: Six months ]Measure change in expression of Ki67 by immunohistochemistry of tissue sample via core biopsy after treatment with single agent Poly(ADP-ribose) polymerase inhibitor (PARPi) (rucaparib).
- Measure and quantify change in number of tumor-infiltrating lymphocytes. [ Time Frame: Six months ]Measure and quantify change in number of tumor-infiltrating lymphocytes via blood testing.
- Measure levels of tumor PARylation in pre- and post-PARPi therapy by IHC. [ Time Frame: Six months ]Measure levels of tumor PARylation (the addition of poly-ADP-ribose polymers) in pre- and post-PARPi therapy by immunohistochemistry of tissue sample via core biopsy.
- Measure change in expression of programmed cell death-1 with ligand (PD-L1) pre- and post-PARPi therapy in circulating tumor cells (CTCs). [ Time Frame: Six months ]Measure change in expression of programmed cell death-1 with ligand (PD-L1) pre- and post-PARPi therapy in circulating tumor cells (CTCs) via blood/plasma collection.
- Measure cfDNA mutational expression for homologous recombination deficiency (HRD) and correlate with PD-L1 expression at baseline and change overtime. [ Time Frame: Six months ]Measure circulating free DNA (cfDNA) mutational expression for homologous recombination deficiency (HRD) and correlate with PD-L1 expression at baseline and change overtime via blood/plasma collection.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have histologically documented triple negative breast cancer (TNBC) (defined as ER expression ≤10% by IHC, progesterone receptor (PR) expression≤10% by IHC and HER2 0 or 1+ by IHC or Fluorescence in situ hybridization (FISH) ratio <2 or human epidermal growth factor receptor 2 (HER2) gene copy number of <6)
- Early stage breast cancer (stage I-III) and not be candidate for neoadjuvant chemotherapy
- Be informed of the investigational nature of the study and all pertinent aspects of the trial
- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines
- Be ≥ 21 years of age
- Have serum creatinine < 1.5 x institutional upper limit of normal (IULN) or a calculated creatinine clearance ≥ 30ml/min (calculated by Cockcroft Gault equation), bilirubin ≤ 2.0, and an serum glutamic oxaloacetic transaminase (SGOT)/s erum glutamic pyruvic transaminase (SGPT)/alkaline phosphatase ≤ 2.0 x IULN
- Have adequate bone marrow function (ANC >1000, Platelets >100,000/ml, Hemoglobin >10gm/dL)
- Women of childbearing potential or male patients of reproductive potential with female partners of childbearing potential must not consider getting pregnant and must avoid pregnancy during the study and for at least 6 months after the last dose of rucaparib. Female and male patients of reproductive potential must practice highly effective methods of contraception with their partners, if of reproductive potential, during treatment and for 6 months following last dose of rucaparib
Exclusion Criteria:
- Ongoing or prior treatment with a PARPi for breast cancer or other malignancies
- Receiving concurrent anti-neoplastic therapy for their breast cancer or another malignancy
- Known documented or suspected hypersensitivity to the components of the study drug or analogs.
- Pre-existing gastrointestinal disorders or defects (like duodenal stent etc) that would, in the opinion of the investigator, interfere with absorption of rucaparib

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911453
Contact: Amy Selegue, BA, BSN, RN | 520.626.0301 | aselegue@email.arizona.edu |
United States, Arizona | |
University of Arizona Cancer Center | Recruiting |
Tucson, Arizona, United States, 85724 | |
Contact: Amy Selegue, BA, BSN, RN 520-626-0301 aselegue@email.arizona.edu |
Principal Investigator: | Pavani Chalasani, MD | University of Arizona |
Responsible Party: | University of Arizona |
ClinicalTrials.gov Identifier: | NCT03911453 |
Other Study ID Numbers: |
30388 1903397220 ( Other Identifier: University of Arizona Cancer Center ) |
First Posted: | April 11, 2019 Key Record Dates |
Last Update Posted: | February 17, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Breast Cancer Triple Negative Breast Tumors PD-L1 |
PARP PARPi Rucaparib |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Rucaparib Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |