Clinical trial · Interventional
Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen
Validating CYP2D6 Genotype-Guided Tamoxifen Therapy for a Multiracial U.S. Population
NCT00764322CI-TRIAL-00028896NRRcompletedPhase 2Results postedClinicalTrials.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: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about differences in DNA and predict how well patients will respond to treatment and plan better treatment. PURPOSE: This clinical trial is studying blood samples from women with breast cancer or ductal carcinoma in situ who are receiving tamoxifen.
Conditions
Conditions (2)
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 |
| Menopausal Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene expression analysis | Genetic | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tamoxifen 20
- description
- One arm, containing the ultra-rapid and extensive metabolizer genotypes, continues treatment with tamoxifen at 20mg.
- interventionNames
- Drug: tamoxifen citrate
- Genetic: gene expression analysis
- Other: pharmacogenomic studies
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- type
- ACTIVE_COMPARATOR
- label
- Tamoxifen 40
- description
- This arm, containing the intermediate and poor metabolizer genotypes, receives escalated treatment with tamoxifen at 40mg.
- interventionNames
- Drug: tamoxifen citrate
- Genetic: gene expression analysis
- Other: pharmacogenomic studies
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.