Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003428
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
1999-11-01
Brief Title:
Hormone Therapy in Treating Women With Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Randomized Double-Blind Evaluation of Two Dose Levels of LY353381 Hydrochloride Administered to Women With Locally Advanced or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 arzoxifene hydrochloride may fight breast cancer by blocking the use of estrogen by the tumor cells
PURPOSE This randomized phase II trial is comparing two different doses of arzoxifene hydrochloride to see how well it works in treating women with advanced or metastatic breast cancer
PURPOSE This randomized phase II trial is comparing two different doses of arzoxifene hydrochloride to see how well it works in treating women with advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES I Compare the response rate or clinical benefit rate in patients with locally advanced or metastatic breast cancer treated with 1 of 2 different doses of arzoxifene hydrochloride II Compare the response rates and clinical benefit rates for patients with tamoxifen-sensitive versus tamoxifen-refractory disease III Compare the degree of toxicity between the 2 doses of arzoxifene hydrochloride in these patients IV Compare the quality of life and survival of these patients receiving high versus low dose arzoxifene hydrochloride V Determine the time to progressive disease time to treatment failure and response duration of this treatment in these patients VII Measure changes in serum estradiol follicle stimulating hormone luteinizing hormone and sex hormone binding globulin in these patients during treatment
OUTLINE This is a randomized double blind study Patients are stratified according to number of metastatic sites less than 3 vs 3 or more tamoxifen sensitivity sensitive vs refractory and degree of estrogen receptor positivity high vs low vs unknown Patients are randomized to receive 1 of 2 doses of arzoxifene hydrochloride Patients receive arzoxifene hydrochloride orally once daily for 12 weeks Treatment continues in the absence of toxicity and disease progression Quality of life is assessed before during and at the completion of the study Patients are followed every 4 weeks for 12 weeks at 30 days after the last treatment and every 2-3 months after the last treatment
PROJECTED ACCRUAL This study will accrue 104-114 patients
OUTLINE This is a randomized double blind study Patients are stratified according to number of metastatic sites less than 3 vs 3 or more tamoxifen sensitivity sensitive vs refractory and degree of estrogen receptor positivity high vs low vs unknown Patients are randomized to receive 1 of 2 doses of arzoxifene hydrochloride Patients receive arzoxifene hydrochloride orally once daily for 12 weeks Treatment continues in the absence of toxicity and disease progression Quality of life is assessed before during and at the completion of the study Patients are followed every 4 weeks for 12 weeks at 30 days after the last treatment and every 2-3 months after the last treatment
PROJECTED ACCRUAL This study will accrue 104-114 patients
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-G98-1451 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066453 | REGISTRY | None | None |
| LILLY-H4Z-MC-JWWDa | None | None | None |