Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290745
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2006-02-09
Brief Title:
Tamoxifen or Letrozole in Treating Women With Ductal Carcinoma in Situ
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Primary Hormonal Therapy for Ductal Carcinoma in Situ Exploration of a Novel Approach to the Clinical Management of Noninvasive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-11
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 Estrogen can cause the growth of breast cancer cells Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes
PURPOSE This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ
PURPOSE This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ
Detailed Description:
OBJECTIVES
Determine the clinical response in women with estrogen receptor-positive ductal carcinoma in situ DCIS treated with neoadjuvant hormonal therapy comprising tamoxifen or letrozole by evaluating the maximal change in tumor diameter on mammography and MRI following treatment
Identify those cellular antigens which are altered by hormonal therapy
Determine which cellular antigens are predictive of clinical response to hormonal therapy
Evaluate whether genomic changes or gene expression in DCIS are altered by hormonal therapy and find candidate genes which are correlated with response to treatment
OUTLINE This is a pilot study
Patients who are premenopausal receive oral tamoxifen once daily for 3 months in the absence of unacceptable toxicity Patients who are post menopausal receive oral letrozole once daily for 3 months in the absence of unacceptable toxicity
After 3 months of hormonal therapy patients undergo lumpectomy or mastectomy
After completion of study treatment patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the clinical response in women with estrogen receptor-positive ductal carcinoma in situ DCIS treated with neoadjuvant hormonal therapy comprising tamoxifen or letrozole by evaluating the maximal change in tumor diameter on mammography and MRI following treatment
Identify those cellular antigens which are altered by hormonal therapy
Determine which cellular antigens are predictive of clinical response to hormonal therapy
Evaluate whether genomic changes or gene expression in DCIS are altered by hormonal therapy and find candidate genes which are correlated with response to treatment
OUTLINE This is a pilot study
Patients who are premenopausal receive oral tamoxifen once daily for 3 months in the absence of unacceptable toxicity Patients who are post menopausal receive oral letrozole once daily for 3 months in the absence of unacceptable toxicity
After 3 months of hormonal therapy patients undergo lumpectomy or mastectomy
After completion of study treatment patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000465205 | OTHER | University of California San Francisco | None |
| UCSF-H10367-19435-05 | OTHER | None | None |
| NCI-2011-01273 | REGISTRY | None | None |