Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00764322 · ClinicalTrials.gov registry record · Phase 2
Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen
A Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 501
- Enrollment target
NCT00764322: Completed Phase 2 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT00764322 is a Phase 2 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 501 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (277% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00764322, a Phase 2 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 501 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into
Interventions
- GENETIC gene expression analysis
- OTHER questionnaire administration
- PROCEDURE quality-of-life assessment
- OTHER pharmacogenomic studies
- DRUG tamoxifen citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 501 participants |
| Start Date | 2008-06-18 |
| Est. Completion | 2011-07-01 |
| Phase | Phase 2 |
What the finished NCT00764322 record still lists
NCT00764322 is an interventional study that assigns participants to a tested intervention. The registered 501 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (277% higher).
The record links to 0 conditions, and to 5 interventions - of which gene expression analysis is the first listed.
NCT00764322 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00764322 about?
NCT00764322 is a clinical study titled "Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen". 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 canc...
What is the current status of trial NCT00764322?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 501 participants. The study started on 2008-06-18. Estimated completion is 2011-07-01.
What interventions are being tested in trial NCT00764322?
The interventions under investigation include: gene expression analysis (GENETIC), questionnaire administration (OTHER), quality-of-life assessment (PROCEDURE), pharmacogenomic studies (OTHER), tamoxifen citrate (DRUG).
Who is sponsoring clinical trial NCT00764322?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00764322's enrollment target sits among peer trials
501 70th of 2000 higher than 1,931 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04442022 · 501 participants · Phase 2
A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- NCT06934525 · 501 participants · NA
Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings
- NCT05646381 · 502 participants · Phase 2
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
- NCT05897632 · 502 participants · NA
CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI