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Ritonavir and Its Effects on Biomarkers in Women Undergoing Surgery for Newly Diagnosed Breast Cancer

2014-08-27 03:18:08 | BioPortfolio

Summary

RATIONALE: Ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cancer cell growth. Studying samples of blood and tissue from patients with breast cancer in the laboratory may help doctors learn more about the effects of ritonavir on biomarkers involved in breast cancer growth.

PURPOSE: This phase I/II trial is studying the best dose of ritonavir and its effects on biomarkers in women undergoing surgery for newly diagnosed breast cancer.

Description

OBJECTIVES:

- Determine the effects of ritonavir on Akt activity, UPR, Ki67 LI, and ROS in a triple-negative breast cancer model.

- Determine the maximum tolerated dose of ritonavir in women with newly diagnosed breast cancer. (Phase I)

OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II study. Five patients with triple-negative breast cancer are enrolled into the control group before the start of phase I recruitment.

- Control: Patients do not receive ritonavir.

- Phases I and II: Patients receive oral ritonavir twice daily for 10 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery as deemed appropriate by the surgeon and based on patient preference (mastectomy or lumpectomy with sentinel node procedure and/or axillary node dissection).

All patients undergo blood and tissue sample collection periodically for biomarker research studies. Samples from patients enrolled in the control group are compared with the samples from patients enrolled in phase I and II.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Breast Cancer

Intervention

ritonavir, therapeutic conventional surgery

Location

Masonic Cancer Center, University of Minnesota
Minneapolis
Minnesota
United States
55455

Status

Recruiting

Source

Masonic Cancer Center, University of Minnesota

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:08-0400

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