Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283608
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2006-01-27
Brief Title:
Pharmacogenetics of Anastrozole in Postmenopausal Women With Estrogen Receptor-Positive andor Progesterone Receptor-Positive Stage I Stage II or Stage III Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pharmacogenetics of Aromatase Inhibitors
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Studying samples of blood in the laboratory from patients with cancer receiving anastrozole may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer It may also help doctors learn more about how anastrozole works in the body
PURPOSE This research study is looking at the pharmacogenetics of anastrozole in postmenopausal women with estrogen receptor-positive ER andor progesterone receptor-positive PR stage I stage II or stage III breast cancer
PURPOSE This research study is looking at the pharmacogenetics of anastrozole in postmenopausal women with estrogen receptor-positive ER andor progesterone receptor-positive PR stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
To evaluate the association of intragenic haplotypes in genes encoding proteins involved in anastrozole metabolism pathways with anastrozole steady state plasma levels in postmenopausal women with estrogen receptor-positive andor progesterone receptor-positive stage I II or III breast cancer
To evaluate the association of intragenic haplotypes in genes that encode proteins involved in pathways for estrogen synthesis metabolism and transport and in genes involved in anastrozole metabolism with the pharmacodynamic PD effects of anastrozole therapy as measured by changes before vs after drug therapy in plasma levels of estradiol estrone estrone sulfate testosterone and androstenedione in these patients
To evaluate the association of intragenic haplotypes described above with the PD effects of anastrozole therapy as measured by changes in breast density and bone mineral density before and at 1 year after drug therapy
To collect and bank blood samples and mammographic bone density and questionnaire data from patients enrolled on CAN-NCIC-MA27 and randomized to receive exemestane
OUTLINE This is a multicenter study Patients are stratified according to prior tamoxifen use yes vs no
Blood samples are obtained for pharmacogenetic studies at baseline at 6-12 weeks and then at 1 year Samples are analyzed for plasma anastrozole concentrations via high-performance liquid chromatography genotyping for htSNPs via PCR plasma levels of estradiol estrone estrone sulfate testosterone and androstenedione via gas chromatographic negative chemical ionization tandem mass spectrometry and liquid chromatographic electrospray tandem mass spectrometry
Mammograms are obtained at baseline ie within the past 6 months and at 1 year to assess breast density Patients with bilateral disease bilateral breast augmentation or bilateral mastectomy do not participate in this portion of the study
Patients at the Mayo Clinic Cancer Center Rochester site also undergo bone mineral density measurement via dual x-ray absorptiometry at baseline and at 1 year Metabolic markers of bone formation and resorption are also assessed in the Mayo Clinic patients
Blood samples and mammographic bone mineral density and questionnaire data collected from patients randomized to receive exemestane on CAN-NCIC-MA27 are stored for future studies
Patients complete a questionnaire at baseline at 6-12 weeks and at 1 year
To evaluate the association of intragenic haplotypes in genes encoding proteins involved in anastrozole metabolism pathways with anastrozole steady state plasma levels in postmenopausal women with estrogen receptor-positive andor progesterone receptor-positive stage I II or III breast cancer
To evaluate the association of intragenic haplotypes in genes that encode proteins involved in pathways for estrogen synthesis metabolism and transport and in genes involved in anastrozole metabolism with the pharmacodynamic PD effects of anastrozole therapy as measured by changes before vs after drug therapy in plasma levels of estradiol estrone estrone sulfate testosterone and androstenedione in these patients
To evaluate the association of intragenic haplotypes described above with the PD effects of anastrozole therapy as measured by changes in breast density and bone mineral density before and at 1 year after drug therapy
To collect and bank blood samples and mammographic bone density and questionnaire data from patients enrolled on CAN-NCIC-MA27 and randomized to receive exemestane
OUTLINE This is a multicenter study Patients are stratified according to prior tamoxifen use yes vs no
Blood samples are obtained for pharmacogenetic studies at baseline at 6-12 weeks and then at 1 year Samples are analyzed for plasma anastrozole concentrations via high-performance liquid chromatography genotyping for htSNPs via PCR plasma levels of estradiol estrone estrone sulfate testosterone and androstenedione via gas chromatographic negative chemical ionization tandem mass spectrometry and liquid chromatographic electrospray tandem mass spectrometry
Mammograms are obtained at baseline ie within the past 6 months and at 1 year to assess breast density Patients with bilateral disease bilateral breast augmentation or bilateral mastectomy do not participate in this portion of the study
Patients at the Mayo Clinic Cancer Center Rochester site also undergo bone mineral density measurement via dual x-ray absorptiometry at baseline and at 1 year Metabolic markers of bone formation and resorption are also assessed in the Mayo Clinic patients
Blood samples and mammographic bone mineral density and questionnaire data collected from patients randomized to receive exemestane on CAN-NCIC-MA27 are stored for future studies
Patients complete a questionnaire at baseline at 6-12 weeks and at 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 999-05 | OTHER | Mayo Clinic IRB | None |
| MC0532 | OTHER | None | None |