Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036868
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2002-05-13
Brief Title:
Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase II Study Of CMF Alone And In Combination With Anti c-erbB2 Antibody Herceptin In Women With c-erbB2 Positive Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-03
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 Drugs used in chemotherapy such as cyclophosphamide methotrexate and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining chemotherapy with trastuzumab may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining combination chemotherapy with trastuzumab in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of combining combination chemotherapy with trastuzumab in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Compare the incidence of clinical heart failure in women with c-erbB2-positive metastatic breast cancer treated with cyclophosphamide methotrexate and fluorouracil in combination with trastuzumab Herceptin
Compare the therapeutic activity of this regimen in terms of objective response rate in these patients
Compare the duration of response and time to progression in patients treated with this regimen
Compare the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive CMF comprising cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 Patients also receive trastuzumab Herceptin IV over 30-90 minutes once weekly beginning on day 1 Treatment repeats every 4 weeks for 8 courses Patients then receive trastuzumab once every 3 weeks in the absence of disease progression unacceptable toxicity or patient refusal
Patients are followed every 8 weeks until documentation of disease progression or initiation of a new anticancer therapy Patients developing disease progression are followed every 12 weeks
PROJECTED ACCRUAL A total of 66 patients will be accrued for this study within 2 years
Compare the incidence of clinical heart failure in women with c-erbB2-positive metastatic breast cancer treated with cyclophosphamide methotrexate and fluorouracil in combination with trastuzumab Herceptin
Compare the therapeutic activity of this regimen in terms of objective response rate in these patients
Compare the duration of response and time to progression in patients treated with this regimen
Compare the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive CMF comprising cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 Patients also receive trastuzumab Herceptin IV over 30-90 minutes once weekly beginning on day 1 Treatment repeats every 4 weeks for 8 courses Patients then receive trastuzumab once every 3 weeks in the absence of disease progression unacceptable toxicity or patient refusal
Patients are followed every 8 weeks until documentation of disease progression or initiation of a new anticancer therapy Patients developing disease progression are followed every 12 weeks
PROJECTED ACCRUAL A total of 66 patients will be accrued for this study within 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 |
|---|---|---|---|
| EORTC-10995 | None | None | None |
| EORTC-16999 | None | None | None |
| IDBBC-EORTC-10995 | None | None | None |