Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2004-04-07
Brief Title:
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
Biomarkers Breast Density And Risk Reduction Perspectives In BRCA Carriers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer Deslorelin combined with low-dose add-back estradiol and testosterone given to replace hormones suppressed by deslorelin may be effective in preventing breast cancer in at-risk women
PURPOSE This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease
PURPOSE This phase II trial is studying how well giving deslorelin together with estradiol and testosterone works in preventing breast cancer in premenopausal women who are at high risk for this disease
Detailed Description:
OBJECTIVES
I Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist GnRHA-based regimen in breast cancer BRCA gene mutation carriers including correlation of changes in mammographic and magnetic resonance imaging MRI densities with tissue morphometrics and biomarkers
II Evaluate perspectives about risk reduction options and impact on quality-of-life QOL measures of participation in the chemopreventive protocol and in risk reduction surgery
OUTLINE
GROUP 1 Patients receive deslorelin estradiol and testosterone intranasally once daily QD for 6 months Patients then undergo planned risk reduction mastectomy
GROUP 2 Patients receive deslorelin estradiol and testosterone intranasally QD for 10 months Patients then undergo continued surveillance through 10 months
After completion of study treatment patients are followed up every 6 months for 2 years
I Assess the effects on the breast of treatment with the gonadotropin-releasing hormone agonist GnRHA-based regimen in breast cancer BRCA gene mutation carriers including correlation of changes in mammographic and magnetic resonance imaging MRI densities with tissue morphometrics and biomarkers
II Evaluate perspectives about risk reduction options and impact on quality-of-life QOL measures of participation in the chemopreventive protocol and in risk reduction surgery
OUTLINE
GROUP 1 Patients receive deslorelin estradiol and testosterone intranasally once daily QD for 6 months Patients then undergo planned risk reduction mastectomy
GROUP 2 Patients receive deslorelin estradiol and testosterone intranasally QD for 10 months Patients then undergo continued surveillance through 10 months
After completion of study treatment patients are followed up every 6 months for 2 years
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 |
|---|---|---|---|
| NCI-2011-00975 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchP30CA033572 |
| P30CA033572 | NIH | None | None |
| CHNMC-IRB-02164 | None | None | None |
| CDR0000355156 | REGISTRY | None | None |