Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516698
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2007-08-14
Brief Title:
Changes in Breast Density and Blood Hormone Levels in Postmenopausal Women Receiving Anastrozole or Exemestane for Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Changes in Breast Density and Plasma Hormone Levels After One Year of Aromatase Inhibitor Therapy
Status:
COMPLETED
Status Verified Date:
2016-07
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 changes in breast density and blood hormone levels in women receiving anastrozole or exemestane for breast cancer may help doctors learn more about the long-term effects of treatment and may help the study of breast cancer in the future
PURPOSE This clinical trial is studying changes in breast density and blood hormone levels in postmenopausal women receiving anastrozole or exemestane for breast cancer
PURPOSE This clinical trial is studying changes in breast density and blood hormone levels in postmenopausal women receiving anastrozole or exemestane for breast cancer
Detailed Description:
OBJECTIVES
To assess the changes in percent breast density in response to 1 year of aromatase inhibitor therapy from levels prior to the initiation of treatment
To assess the changes in dense area in response to 1 year of aromatase inhibitor therapy from levels prior to the initiation of treatment
To examine whether changes in percent breast density in response to 1 year of aromatase inhibitor therapy from pre-treatment levels correlate with changes in plasma hormone levels estrone estrone-sulfate estradiol and SHBG and drug levels anastrozole or exemestane over the same time period
To examine whether changes in dense area in response to 1 year of aromatase inhibitor therapy from pre-treatment mammogram correlate with changes in plasma hormone levels estrone estrone-sulfate estradiol and SHBG and drug levels anastrozole or exemestane over the same time period
To assess whether women with high pre-treatment percent density upper tertile experience greater decreases in percent breast density after 1 year of aromatase inhibitor therapy than women with low pre-treatment percent density lower tertile
To assess whether women with high pre-treatment dense area upper tertile experience greater decreases in dense area after 1 year of aromatase inhibitor therapy than women with low pre-treatment dense area lower tertile
To examine the associations of haplotype-tagged single nucleotide polymorphisms in genes in the aromatase pathway identified through the Mayo Clinic and Indiana University Pharmacogenomics Research Network Projects with changes in percent and area density plasma hormone levels and drug levels after 1 year of aromatase inhibitor therapy
OUTLINE This is a multicenter study
Patients undergo blood sample collection at baseline and at 1 year after initiation of aromatase inhibitor therapy anastrozole or exemestane Samples are analyzed for estrogen and testosterone levels and additional hormone levels and growth factors that have been previously linked with breast density and that could be altered by aromatase inhibitor use ie sex hormone-binding globulin SHBG DHEA DHEA sulfate progesterone prolactin insulin-like growth factor-1 IGF-1 and insulin-like growth factor binding protein 3 IGF BP3 Samples are also analyzed for anastrozole and exemestane levels by HPLC Pharmacogenetic studies are also performed Haplotype-tagged single nucleotide polymorphisms in genes in the aromatase pathway are examined
Patients also undergo mammogram at baseline 6 months prior to study registration and at 1 year after initiation of aromatase inhibitor therapy
To assess the changes in percent breast density in response to 1 year of aromatase inhibitor therapy from levels prior to the initiation of treatment
To assess the changes in dense area in response to 1 year of aromatase inhibitor therapy from levels prior to the initiation of treatment
To examine whether changes in percent breast density in response to 1 year of aromatase inhibitor therapy from pre-treatment levels correlate with changes in plasma hormone levels estrone estrone-sulfate estradiol and SHBG and drug levels anastrozole or exemestane over the same time period
To examine whether changes in dense area in response to 1 year of aromatase inhibitor therapy from pre-treatment mammogram correlate with changes in plasma hormone levels estrone estrone-sulfate estradiol and SHBG and drug levels anastrozole or exemestane over the same time period
To assess whether women with high pre-treatment percent density upper tertile experience greater decreases in percent breast density after 1 year of aromatase inhibitor therapy than women with low pre-treatment percent density lower tertile
To assess whether women with high pre-treatment dense area upper tertile experience greater decreases in dense area after 1 year of aromatase inhibitor therapy than women with low pre-treatment dense area lower tertile
To examine the associations of haplotype-tagged single nucleotide polymorphisms in genes in the aromatase pathway identified through the Mayo Clinic and Indiana University Pharmacogenomics Research Network Projects with changes in percent and area density plasma hormone levels and drug levels after 1 year of aromatase inhibitor therapy
OUTLINE This is a multicenter study
Patients undergo blood sample collection at baseline and at 1 year after initiation of aromatase inhibitor therapy anastrozole or exemestane Samples are analyzed for estrogen and testosterone levels and additional hormone levels and growth factors that have been previously linked with breast density and that could be altered by aromatase inhibitor use ie sex hormone-binding globulin SHBG DHEA DHEA sulfate progesterone prolactin insulin-like growth factor-1 IGF-1 and insulin-like growth factor binding protein 3 IGF BP3 Samples are also analyzed for anastrozole and exemestane levels by HPLC Pharmacogenetic studies are also performed Haplotype-tagged single nucleotide polymorphisms in genes in the aromatase pathway are examined
Patients also undergo mammogram at baseline 6 months prior to study registration and at 1 year after initiation of aromatase inhibitor therapy
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 |
|---|---|---|---|
| CDR0000560200 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02719 | REGISTRY | None | None |