Breast Neoplasms Clinical Trial
— MHSLabCorp1Official title:
Tamoxifen Pharmacogenomics and the Prevention of Recurrent Breast Cancer
Verified date | October 2009 |
Source | Medco Health Solutions, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This study will assess the impact of CYP450 2D6 genotype pharmacogenetic testing and the corresponding prescribing impact for postmenopausal women using tamoxifen in a patient care setting for prevention of recurrent breast cancer.
Status | Completed |
Enrollment | 184 |
Est. completion date | January 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Patient currently has a pharmacy benefit with Medco for an enrolled client - Patient has a adjudicated tamoxifen pharmacy claims within the last six months - Patient is still taking tamoxifen to prevent recurrent breast cancer - Patient is a natural postmenopausal women 50 years of age or older - Patient signs consent - Patient is willing to provide sample for genetic testing - Physician managing tamoxifen therapy is willing to order pharmacogenetic test Exclusion Criteria: - Patient is male - Patient is under 50 years old - Patient has previous history of CYP450 2D6 testing - Patient is no longer taking tamoxifen - Patient refuses to sign consent - Patient wishes to no longer participate after testing - Patient's physician refuses to order pharmacogenetic test |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Robert Epstein | Franklin Lakes | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Medco Health Solutions, Inc. | Indiana University School of Medicine, International Business Machines (IBM), Laboratory Corporation of America (LabCorp), Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the prevalence of different CYP450 2D6 phenotypes including poor metabolism status | 14 months | No | |
Secondary | Determine the prevalence of concomitant drug therapy involving tamoxifen and potent CYP450 2D6 inhibitors | 14 months | No | |
Secondary | Determine the effect of CYP450 2D6 genotyping that indicates poor metabolism status has on physician willingness to change tamoxifen therapy within 60 days of receiving test results and accompanying interpretations | 60 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT03664778 -
Abbreviated Breast MRI After Cancer Treatment
|
||
Recruiting |
NCT03144622 -
18F-FSPG PET/CT Imaging in Patients With Cancers
|
||
Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
Active, not recruiting |
NCT04568902 -
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT02860585 -
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03698942 -
Delphinus SoftVueâ„¢ ROC Reader Study
|
||
Completed |
NCT00092950 -
Exercise in Women at Risk for Breast Cancer
|
Phase 2 | |
Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02151071 -
The Breast Surgery EnLight and LightPath Imaging System Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT02934360 -
TR(ACE) Assay Clinical Specimen Study
|
N/A | |
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A | |
Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
N/A |