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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborator: Susan G. Komen Breast Cancer Foundation
• Treatments: Ritonavir

Criteria

Inclusion criteria:

• Newly diagnosed biopsy proven breast cancer for which a lumpectomy or mastectomy is planned.

• Control Selection

• ER+, HER2-: estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2 -) as defined according to institutional standards.

• Phase I Selection

• ER+, HER2-

• ER+, HER2+

• ER-, HER2+

• ER-, PR+, HER2-

• ER-, PR-, HER2-

• Phase II Selection

• ER+HER2-: as defined for controls Menstrual status will be noted as either pre- or postmenopausal. For the purpose of this study, postmenopausal is defined as no menstrual period for 12 months or longer or bilateral oophorectomy

• Sufficient tumor tissue from the diagnostic core biopsy, either as a block or a minimum of 5 slides

• Tumor must be greater than 1 centimeter as measured by clinical exam, mammogram, ultrasound or MRI. - No prior treatment for breast cancer in the affected breast.

• Karnofsky performance status >70%

• No prior treatment for breast cancer in the affected breast

• Adequate organ function for receiving study drug within 14 days 1st dose of study drug

• Women of childbearing potential are required to use an effective method of contraception

• Voluntary written consent

Exclusion criteria:

• Pregnant or lactating.

• Known positive HIV status or on medications for HIV

• Diagnosis of diabetes due to potential problems with insulin resistance and hyperglycemia

• Any pre-existing gastrointestinal complaints including nausea, abdominal pain and/or diarrhea

• Known hypersensitivity to ritonavir or any of the tablet ingredients

• Co-administration of ritonavir is contraindicated with any of the drugs - Contraindicated Drugs because competition for primarily CYP3A by ritonavir could result in inhibition of the metabolism of these drugs and create the potential for serious and/or life-threatening reactions such as cardiac arrhythmias, prolonged or increased sedation, and respiratory depression. Voriconazole is an exception in that co-administration of ritonavir and voriconazole results in a significant decrease in plasma concentrations of voriconazole. If the patient cannot discontinue a contraindicated drug, she is not eligible for the trial.

• Incompatible Drugs