Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057993
Status:
WITHDRAWN
Last Update Posted:
2012-06-11
First Post:
2003-04-07
Brief Title:
Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive HER2NEU Positive Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to accrue subjects to the study after 2 years - closed per request by Data Monitoring Committee
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells Estrogen can stimulate the growth of breast cancer cells Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen Combining trastuzumab with exemestane may be an effective treatment for breast cancer with high amounts of HER2
PURPOSE Phase II trial to study the effectiveness of combining trastuzumab with exemestane in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast cancer
PURPOSE Phase II trial to study the effectiveness of combining trastuzumab with exemestane in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of exemestane and trastuzumab Herceptin in terms of response rate and time to progression in postmenopausal women with metastatic or locally advanced hormone-responsive HER2neu positive breast cancer
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive trastuzumab Herceptin IV over 30-90 minutes on day 1 and oral exemestane once daily Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-60 patients will be accrued for this study
Determine the efficacy of exemestane and trastuzumab Herceptin in terms of response rate and time to progression in postmenopausal women with metastatic or locally advanced hormone-responsive HER2neu positive breast cancer
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive trastuzumab Herceptin IV over 30-90 minutes on day 1 and oral exemestane once daily Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 18-60 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 |
|---|---|---|---|
| PHARMACIA-NU-01B4 | None | None | None |
| NU-01B4 | None | None | None |