Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041119
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2002-07-08
Brief Title:
Four Versus Six Cycles of CyclophosphamideDoxorubicin or Paclitaxel in Adjuvant Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Cyclophosphamide And Doxorubicin CA 4 VS 6 Cycles Versus Paclitaxel 4 VS 6 Cycles As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph NodesA 2X2 Factorial Phase III Randomized Study
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back adjuvant therapy Drugs used in chemotherapy such as cyclophosphamide doxorubicin hydrochloride and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the equivalence of paclitaxel given every two weeks with cyclophosphamide and doxorubicin hydrochloride CA given every two weeks as adjuvant therapy for women with 0-3 positive axillary lymph nodes for disease-free survival
II To determine if longer therapy 12 weeks is superior to shorter therapy 8 weeks of either CA or paclitaxel for disease-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes
SECONDARY OBJECTIVES
I To determine the equivalence of paclitaxel given every two weeks with CA given every two weeks and the potential superiority of longer vs shorter therapy in relation to overall survival local control regardless of metastatic status and time to distant metastases regardless of local recurrence status
II To compare toxicities of short and long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer
III To determine the effect of long and short course CA and paclitaxel on the induction of menopause for pre-menopausal patients
IV To assess the discrepancy of myelosuppression among the common multidrug resistance protein 1 MDR1 haplotypes in the CA treatment arm
V To assess the effect of MDR1 haplotypes on disease-free survival DFS adjusted for treatment
VI Exploratory analysis of the effect of cytochrome P450 family 3 subfamily A polypeptide 5 CYP3A5 cytochrome P450 family 2 subfamily C polypeptide 8 CYP2C8 and cytochrome P450 family 2 subfamily B polypeptide 6 CYP2B6 polymorphisms on DFS and toxicity
VII To identify genetic markers associated with the risk of developing neutropenia in adriamycin cyclophosphamide-treated breast cancer patients
VIII To identify genetic markers associated with the risk of developing peripheral neuropathy in paclitaxel-treated breast cancer patients
IX To identify genetic markers associated with differences in the efficacy of each chemotherapy regimen
X To examine genetic associations with other response and toxicity phenotypes that become apparent during future analysis of Cancer and Leukemia Group B CALGB 40101 data
XI To identify copy number variants associated with adriamycincyclophosphamide-induced neutropenia and paclitaxel-induced peripheral neuropathy
OUTLINE Patients are randomized to 1 of 4 treatment arms
ARM I Patients receive cyclophosphamide intravenously IV and doxorubicin hydrochloride IV on day 1 Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
ARM III Patients receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity
ARM IV Patients receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
Note Randomization to Arms II and IV is no longer available effective 12152007
After completion of study treatment patients are followed up for 4-6 weeks every 6 months for 2 years and then annually for up to 13 years
I To determine the equivalence of paclitaxel given every two weeks with cyclophosphamide and doxorubicin hydrochloride CA given every two weeks as adjuvant therapy for women with 0-3 positive axillary lymph nodes for disease-free survival
II To determine if longer therapy 12 weeks is superior to shorter therapy 8 weeks of either CA or paclitaxel for disease-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes
SECONDARY OBJECTIVES
I To determine the equivalence of paclitaxel given every two weeks with CA given every two weeks and the potential superiority of longer vs shorter therapy in relation to overall survival local control regardless of metastatic status and time to distant metastases regardless of local recurrence status
II To compare toxicities of short and long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer
III To determine the effect of long and short course CA and paclitaxel on the induction of menopause for pre-menopausal patients
IV To assess the discrepancy of myelosuppression among the common multidrug resistance protein 1 MDR1 haplotypes in the CA treatment arm
V To assess the effect of MDR1 haplotypes on disease-free survival DFS adjusted for treatment
VI Exploratory analysis of the effect of cytochrome P450 family 3 subfamily A polypeptide 5 CYP3A5 cytochrome P450 family 2 subfamily C polypeptide 8 CYP2C8 and cytochrome P450 family 2 subfamily B polypeptide 6 CYP2B6 polymorphisms on DFS and toxicity
VII To identify genetic markers associated with the risk of developing neutropenia in adriamycin cyclophosphamide-treated breast cancer patients
VIII To identify genetic markers associated with the risk of developing peripheral neuropathy in paclitaxel-treated breast cancer patients
IX To identify genetic markers associated with differences in the efficacy of each chemotherapy regimen
X To examine genetic associations with other response and toxicity phenotypes that become apparent during future analysis of Cancer and Leukemia Group B CALGB 40101 data
XI To identify copy number variants associated with adriamycincyclophosphamide-induced neutropenia and paclitaxel-induced peripheral neuropathy
OUTLINE Patients are randomized to 1 of 4 treatment arms
ARM I Patients receive cyclophosphamide intravenously IV and doxorubicin hydrochloride IV on day 1 Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
ARM III Patients receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity
ARM IV Patients receive paclitaxel IV over 3 hours on day 1 Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity
Note Randomization to Arms II and IV is no longer available effective 12152007
After completion of study treatment patients are followed up for 4-6 weeks every 6 months for 2 years and then annually for up to 13 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 |
|---|---|---|---|
| CDR0000069444 | REGISTRY | None | None |
| NCI-2009-00474 | REGISTRY | None | None |
| U10CA180821 | NIH | CTRP Clinical Trials Reporting System | httpsreporternihgovquickSearchU10CA180821 |