Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004237
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2000-01-28
Brief Title:
Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of NavelbineEpirubicin Versus NavelbineMitozantrone Versus CyclophosphamideAdriamycin as Preoperative Chemotherapy in Patients With or 3cm Diameter Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2005-05
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE This randomized phase II trial is studying three regimens of combination chemotherapy to compare how well they work in treating women with stage I or stage II breast cancer
PURPOSE This randomized phase II trial is studying three regimens of combination chemotherapy to compare how well they work in treating women with stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of vinorelbineepirubicin and vinorelbinemitoxantrone in terms of clinical objective tumor response clinical complete remission and pathological complete remission in women with early stage breast cancer
Compare the efficacy of these 2 new regimens with an established regimen of cyclophosphamidedoxorubicin in a randomly selected control group of patients
Compare the toxicity and side effects of these 2 new regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to center and age under 50 vs 50 and over Patients are randomized to one of three treatment arms
Arm I Patients receive vinorelbine IV on days 1 and 8 and epirubicin IV on day 1
Arm II Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 1
Arm III Patients receive doxorubicin IV and cyclophosphamide IV on day 1 Treatment continues every 3 weeks for 6 courses in the absence of unacceptable toxicity or disease progression All patients except those who are under 50 and whose tumors are estrogen receptor negative receive oral adjuvant tamoxifen daily in addition to chemotherapy
All patients are offered surgery following completion of chemotherapy Radiotherapy begins within 4 weeks of completion of chemotherapy or surgery whichever is the immediately preceding treatment
Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 62-125 patients will be accrued for this study within 12-18 months
Determine the efficacy of vinorelbineepirubicin and vinorelbinemitoxantrone in terms of clinical objective tumor response clinical complete remission and pathological complete remission in women with early stage breast cancer
Compare the efficacy of these 2 new regimens with an established regimen of cyclophosphamidedoxorubicin in a randomly selected control group of patients
Compare the toxicity and side effects of these 2 new regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to center and age under 50 vs 50 and over Patients are randomized to one of three treatment arms
Arm I Patients receive vinorelbine IV on days 1 and 8 and epirubicin IV on day 1
Arm II Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 1
Arm III Patients receive doxorubicin IV and cyclophosphamide IV on day 1 Treatment continues every 3 weeks for 6 courses in the absence of unacceptable toxicity or disease progression All patients except those who are under 50 and whose tumors are estrogen receptor negative receive oral adjuvant tamoxifen daily in addition to chemotherapy
All patients are offered surgery following completion of chemotherapy Radiotherapy begins within 4 weeks of completion of chemotherapy or surgery whichever is the immediately preceding treatment
Patients are followed every 3 months for the first 2 years every 6 months for the next 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 62-125 patients will be accrued for this study within 12-18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-99037 | None | None | None |
| RMNHS-TOPIC2 | None | None | None |