Clinical trial · Interventional
Ritonavir and Its Effects on Biomarkers in Women Undergoing Surgery for Newly Diagnosed Breast Cancer
A Phase I/II Trial of Short Course Pre-Operative Ritonavir To Determine Akt Inhibition in Breast Cancer
NCT01009437CI-TRIAL-00030657completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ritonavir | Drug | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Control Arm - No Ritonavir
- description
- Five ER+, HER2- breast cancer patients meeting all study eligibility will be enrolled prior to the start of phase I recruitment to act as controls (no ritonavir will be given-will receive therapeutic conventional surgery) to confirm that anesthesia does not affect EET levels. Core biopsies, surgical tumor/normal tissue and pre- and post- surgery blood samples will be collected for comparison with the treatment group.
- interventionNames
- Procedure: therapeutic conventional surgery
- type
- EXPERIMENTAL
- label
- Ritonavir - Escalating Doses (I)
- description
- Standard phase I dose escalation (with therapeutic conventional surgery) will be used with 3 levels of ritonavir given - 200 mg bid, 400 mg bid, and 600 mg bid for the following groups: 1. ER+, HER2- 2. ER+, HER2+ 3. ER-, HER2+ 4. ER-, PR+, HER2- 5. ER-, PR-, HER2-
- interventionNames
- Drug: ritonavir
- Procedure: therapeutic conventional surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.