Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen
Breast Cancer · Menopausal Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT00764322 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tamoxifen citrate (Drug); gene expression analysis (Genetic); pharmacogenomic studies (Other); questionnaire administration (Other); quality-of-life assessment (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes |
8.4; 10.00; 7.10; 3.42; 15.35; 9.30 | — |
| SECONDARY Number of Participants With Pulmonary Embolism (PE), Deep Vein Thrombosis (DVT), Stroke, and/or Endometrial Cancer |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Median Endoxifen Concentrations to Determine Feasibility of Obtaining Pharmacogenomic Information From Patients in the Clinical Setting and Using it to Guide Changes in Therapy |
-1.5; 7.6; 6.1 | — |
| SECONDARY CYP2D6 Allele Frequencies and Endoxifen Levels Among African-American Women Taking Tamoxifen Citrate |
14.58; 9.69; 7.09; 0.8 | — |
| SECONDARY Change in Plasma Endoxifen Levels After an Increase in Tamoxifen Citrate Dose From 20 mg to 40 mg Daily in Patients With Poor-metabolizing Genotypes |
6.1 | — |
| SECONDARY Patient Understanding of Pharmacogenomics |
47; 48; 53; 22; 30; 40 | — |
Summary
Eligibility Criteria
Inclusion:
Histologically confirmed invasive carcinoma of the breast or ductal breast carcinoma in situ Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months either for the treatment of invasive or non-invasive carcinoma of the breast or for breast cancer recurrence prevention
- Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor status not specified Concurrent participation in non-treatment studies allowed provided it will not interfere with participation in this study Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy ≥ 6 months Absolute Neutrophil Count (ANC) ≥ 1.0 x 10^9/L Platelet count ≥ 100 x 10^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times Upper Limit of Normal (ULN) Total bilirubin ≤ 2.5 times ULN Creatinine clearance ≥ 50 mL/min Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No limitations to number of prior therapies
- No limitations for prior radiotherapy
- More than 14 days since prior and no other concurrent investigational agent
Exclusion:
Not pregnant or nursing No active, serious infection or medical or psychiatric illness likely to preclude study participation No psychiatric conditions that would preclude study compliance or informed consent No history of venous thromboembolism, transient ischemic attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate or any of its reagents No concurrent coumadin
No concurrent medications known to inhibit CYP2D6, including any of the following:
- Amiodarone
- Haloperidol
- Indinavir
- Ritonavir
- Quinidine
No concurrent selective serotonin reuptake inhibitors, except the following:
- Venlafaxine
- Citalopram
Data sourced from ClinicalTrials.gov (NCT00764322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.