Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024102
Status:
COMPLETED
Last Update Posted:
2016-08-12
First Post:
2001-09-13
Brief Title:
Comparison of Combination Chemotherapy Regimens in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens Cyclophosphamide Methotrexate and Fluorouracil - CMF or Doxorubicin and Cyclophosphamide - AC Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-07
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 and giving them in different ways after surgery may kill more tumor cells It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer
PURPOSE This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer
PURPOSE This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer
Detailed Description:
OBJECTIVES
Compare the effectiveness of adjuvant chemotherapy comprising standard cyclophosphamide methotrexate and fluorouracil CMF or doxorubicin and cyclophosphamide AC vs oral capecitabine in terms of disease-free and overall survival in elderly women with operable adenocarcinoma of the breast
Compare the quality of life and physical functioning of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Evaluate the adherence of older patients to an oral chemotherapy regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to age 65 to 69 vs 70 to 80 vs over 80 performance status 0-1 vs 2 and HER2 status positive vs negative vs unknown Patients are randomized to 1 of 2 treatment arms
Arm I Patients with insufficient left ventricular ejection fraction LVEF are assigned to group A Patients with normal LVEF are assigned to group A or B based on physicianpatient choice
Group A CMF Patients receive oral cyclophosphamide CTX daily on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Group B AC Patients receive doxorubicin IV and CTX IV on day 1 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Beginning within 12 weeks after treatment in arm I or II patients with estrogen or progesterone receptor-positive disease receive oral tamoxifen or an aromatase inhibitor daily for 5 years
Beginning 4-6 weeks after treatment in arm I or II eligible patients who previously underwent breast conservation surgery undergo radiotherapy
Quality of life is assessed at baseline at 6 weeks group B 9 weeks arm II or 12 weeks group A and then at 1 12 18 and 24 months after study
Drug adherence is assessed at 9 weeks during study arm II
Patients are followed at 1 month every 6 months for 2 years and then annually for 15 years
PROJECTED ACCRUAL A total of 600-1800 patients 300-900 per treatment arm will be accrued for this study within 2-6 years
Compare the effectiveness of adjuvant chemotherapy comprising standard cyclophosphamide methotrexate and fluorouracil CMF or doxorubicin and cyclophosphamide AC vs oral capecitabine in terms of disease-free and overall survival in elderly women with operable adenocarcinoma of the breast
Compare the quality of life and physical functioning of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Evaluate the adherence of older patients to an oral chemotherapy regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to age 65 to 69 vs 70 to 80 vs over 80 performance status 0-1 vs 2 and HER2 status positive vs negative vs unknown Patients are randomized to 1 of 2 treatment arms
Arm I Patients with insufficient left ventricular ejection fraction LVEF are assigned to group A Patients with normal LVEF are assigned to group A or B based on physicianpatient choice
Group A CMF Patients receive oral cyclophosphamide CTX daily on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Group B AC Patients receive doxorubicin IV and CTX IV on day 1 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral capecitabine twice daily on days 1-14 Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Beginning within 12 weeks after treatment in arm I or II patients with estrogen or progesterone receptor-positive disease receive oral tamoxifen or an aromatase inhibitor daily for 5 years
Beginning 4-6 weeks after treatment in arm I or II eligible patients who previously underwent breast conservation surgery undergo radiotherapy
Quality of life is assessed at baseline at 6 weeks group B 9 weeks arm II or 12 weeks group A and then at 1 12 18 and 24 months after study
Drug adherence is assessed at 9 weeks during study arm II
Patients are followed at 1 month every 6 months for 2 years and then annually for 15 years
PROJECTED ACCRUAL A total of 600-1800 patients 300-900 per treatment arm will be accrued for this study within 2-6 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CAN-NCIC-MAC1 | None | None | None |
| CDR0000068891 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |