Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093795
Status:
COMPLETED
Last Update Posted:
2018-01-11
First Post:
2004-10-06
Brief Title:
Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Phase III Adjuvant Trial Comparing Three Chemotherapy Regimens in Women With Node-Positive Breast Cancer DocetaxelDoxorubicinCyclophosphamide TAC Dose-Dense DD DoxorubicinCyclophosphamide Followed By DD Paclitaxel DD ACP DD AC Followed By DD Paclitaxel Plus Gemcitabine DD ACPG
Status:
COMPLETED
Status Verified Date:
2017-12
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 docetaxel doxorubicin cyclophosphamide paclitaxel and gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Giving combination chemotherapy after surgery may kill any remaining tumor cells
PURPOSE This randomized phase III trial is studying three different combination chemotherapy regimens and comparing how well they work in treating women who have undergone surgery for node-positive breast cancer
PURPOSE This randomized phase III trial is studying three different combination chemotherapy regimens and comparing how well they work in treating women who have undergone surgery for node-positive breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare disease-free survival in women with node-positive breast cancer treated with 3 different adjuvant chemotherapy regimens comprising dose-dense doxorubicin cyclophosphamide paclitaxel and gemcitabine vs docetaxel doxorubicin and cyclophosphamide vs dose-dense doxorubicin cyclophosphamide and paclitaxel
Secondary
Compare overall survival recurrence-free interval and distant recurrence-free interval in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to number of positive lymph nodes 1-3 vs 4-9 vs 10 hormone receptor status estrogen receptor ER- and progesterone receptor PgR- negative vs ER- andor PgR-positive type of prior surgery and planned radiotherapy lumpectomy and local radiotherapy RT without regional RT vs lumpectomy and local RT with regional RT vs mastectomy without RT vs mastectomy with local or regional RT Patients are randomized to 1 of 3 treatment arms
Group 1 Patients receive doxorubicin IV over 15 minutes cyclophosphamide IV over 30 minutes and docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for 6 courses
Group 2 Patients receive AC chemotherapy comprising doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 14 days for 4 courses Beginning 14 days after the last dose of AC patients receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 14 days for 4 courses
Group 3 Patients receive AC chemotherapy as in Group 2 Beginning 14 days after the last dose of AC patients receive paclitaxel as in Group 2 and gemcitabine IV over 30-60 minutes on day 1 Treatment repeats every 14 days for 4 courses
In all arms treatment continues in the absence of disease progression or unacceptable toxicity
Beginning 3-12 weeks after the last dose of chemotherapy patients with ER-positive andor PgR-positive tumors receive hormonal therapy
Beginning no sooner than 3 weeks after the last dose of chemotherapy patients treated with lumpectomy undergo whole-breast radiotherapy Patients treated with mastectomy may undergo chest wall andor regional nodal radiotherapy
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 4800 patients will be accrued for this study within 4 years
Primary
Compare disease-free survival in women with node-positive breast cancer treated with 3 different adjuvant chemotherapy regimens comprising dose-dense doxorubicin cyclophosphamide paclitaxel and gemcitabine vs docetaxel doxorubicin and cyclophosphamide vs dose-dense doxorubicin cyclophosphamide and paclitaxel
Secondary
Compare overall survival recurrence-free interval and distant recurrence-free interval in patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to number of positive lymph nodes 1-3 vs 4-9 vs 10 hormone receptor status estrogen receptor ER- and progesterone receptor PgR- negative vs ER- andor PgR-positive type of prior surgery and planned radiotherapy lumpectomy and local radiotherapy RT without regional RT vs lumpectomy and local RT with regional RT vs mastectomy without RT vs mastectomy with local or regional RT Patients are randomized to 1 of 3 treatment arms
Group 1 Patients receive doxorubicin IV over 15 minutes cyclophosphamide IV over 30 minutes and docetaxel IV over 1 hour on day 1 Treatment repeats every 21 days for 6 courses
Group 2 Patients receive AC chemotherapy comprising doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 14 days for 4 courses Beginning 14 days after the last dose of AC patients receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 14 days for 4 courses
Group 3 Patients receive AC chemotherapy as in Group 2 Beginning 14 days after the last dose of AC patients receive paclitaxel as in Group 2 and gemcitabine IV over 30-60 minutes on day 1 Treatment repeats every 14 days for 4 courses
In all arms treatment continues in the absence of disease progression or unacceptable toxicity
Beginning 3-12 weeks after the last dose of chemotherapy patients with ER-positive andor PgR-positive tumors receive hormonal therapy
Beginning no sooner than 3 weeks after the last dose of chemotherapy patients treated with lumpectomy undergo whole-breast radiotherapy Patients treated with mastectomy may undergo chest wall andor regional nodal radiotherapy
Patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 4800 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| U10CA012027 | NIH | None | httpsreporternihgovquickSearchU10CA012027 |