Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084396
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2004-06-10
Brief Title:
Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive andor Progesterone-Receptor Positive Stage II Stage IIIA or Stage IIIB Breast Cancer
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase 2 Trial Of 4 Months Preoperative Letrozole 25 mg Daily For Postmenopausal Women With Estrogen Receptor Positive AndOr Progesterone Receptor Positive T2 T3 T4a-c N0-2 M0 Breast Cancer- Novel Biomarkers for Aromatase Inhibitor Therapy
Status:
COMPLETED
Status Verified Date:
2016-09
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 stimulate the growth of breast cancer cells Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen Giving letrozole before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well neoadjuvant letrozole works in treating postmenopausal women who are undergoing surgery for estrogen-receptor positive or progesterone-receptor positive stage II stage IIIA or stage IIIB breast cancer
PURPOSE This phase II trial is studying how well neoadjuvant letrozole works in treating postmenopausal women who are undergoing surgery for estrogen-receptor positive or progesterone-receptor positive stage II stage IIIA or stage IIIB breast cancer
Detailed Description:
OBJECTIVES
Primary
Develop a predictive model of response based on gene expression profiling in postmenopausal women with estrogen- andor progesterone-receptor positive stage II IIIA or IIIB breast cancer treated with neoadjuvant letrozole
Secondary
Determine the response rate in patients treated with this drug
Determine changes in Ki67 proliferation rates in patients treated with this drug
Determine the rate of improvement in surgical outcomes in patients treated with this drug
Determine the long-term outcomes in patients treated with this drug
Determine the safety of this drug in these patients
Determine mechanisms of resistance to this drug in these patients
OUTLINE This is a multicenter study
Patients receive neoadjuvant oral letrozole once daily for 16 weeks in the absence of disease progression Patients then undergo breast surgery one day after the last dose of letrozole Patients with partial response after 16 weeks may continue to receive letrozole for an additional 8 weeks before undergoing breast surgery
Patients are followed within 4 weeks after definitive surgery and then annually for 10 years
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study
Primary
Develop a predictive model of response based on gene expression profiling in postmenopausal women with estrogen- andor progesterone-receptor positive stage II IIIA or IIIB breast cancer treated with neoadjuvant letrozole
Secondary
Determine the response rate in patients treated with this drug
Determine changes in Ki67 proliferation rates in patients treated with this drug
Determine the rate of improvement in surgical outcomes in patients treated with this drug
Determine the long-term outcomes in patients treated with this drug
Determine the safety of this drug in these patients
Determine mechanisms of resistance to this drug in these patients
OUTLINE This is a multicenter study
Patients receive neoadjuvant oral letrozole once daily for 16 weeks in the absence of disease progression Patients then undergo breast surgery one day after the last dose of letrozole Patients with partial response after 16 weeks may continue to receive letrozole for an additional 8 weeks before undergoing breast surgery
Patients are followed within 4 weeks after definitive surgery and then annually for 10 years
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study
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 |
|---|---|---|---|
| UCSF-H8409-21398-04 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA091842 |
| R01CA095614 | NIH | None | None |
| P30CA091842 | NIH | None | None |
| WU-03-0586 | None | None | None |
| UCSF-02755 | None | None | None |