Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433511
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2007-02-08
Brief Title:
Doxorubicin Hydrochloride Cyclophosphamide and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk Lymph Node-Negative Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 doxorubicin hydrochloride cyclophosphamide and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes lymph node-positive or cancer that has not spread to the lymph nodes but is at high risk for returning high-risk lymph node-negative breast cancer Drugs used in chemotherapy such as doxorubicin hydrochloride cyclophosphamide 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 Monoclonal antibodies such as bevacizumab may interfere with the ability of tumor cells to grow and spread Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning It is not yet known whether doxorubicin hydrochloride cyclophosphamide and paclitaxel are more effective with or without bevacizumab
Detailed Description:
PRIMARY OBJECTIVES
I To determine the disease-free survival of patients defined as invasive disease-free survival IFDS with lymph node positive and high risk lymph node negative breast cancer randomized to treatment with either doxorubicin doxorubicin hydrochloridecyclophosphamide plus placebo followed by paclitaxel AC placebo T placebo or the same chemotherapy regimen plus bevacizumab
SECONDARY OBJECTIVES
I To compare short-term 20-24 weeks versus long-term 50-54 weeks bevacizumab therapy
II To compare the overall survival III To evaluate toxicity IV To evaluate the association between outcomes in E5103 disease-free survival overall survival and toxicities and genotype derived from candidate single nucleotide polymorphisms and genome wide evaluations
V To compare the quality of life of breast cancer patients treated with ACpaclitaxel and bevacizumab or placebo in terms of physical symptoms physical functioning psychological state and social functioning over an 18 month period
VI To determine the impact of theoretical biomarker information on patients willingness to accept the toxicities of bevacizumab for the estimated potential benefit
VII To create a biospecimen repository including plasma serum and CellSearch cassettes containing circulating tumor cells CTC for evaluating determinants of late relapse including candidate biomarkers reflecting occult tumor burden eg CTCs and plasma tumor deoxyribonucleic acid DNA and host factors eg estrogen insulin-insulin-like growth factor IGF axis inflammation etc
VIII To create a biorepository of metastatic tumor samples in patients who have had a late relapse
IX To determine body mass index BMI and comorbidity burden in patients with operable breast cancer five or more years after diagnosis
X To determine whether there is a relationship between late relapse and BMI at diagnosis and at 5 years after diagnosis and whether BMI-associated inflammatory andor metabolic biomarkers are associated with early and late recurrence
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive doxorubicin hydrochloride intravenously IV cyclophosphamide IV over 20-30 minutes and placebo IV over 30-90 minutes on day 1 Treatment repeats every 2 or 3 weeks for 4 courses Beginning 3 weeks later patients then receive paclitaxel IV over 1 hour on days 1 8 and 15 and placebo IV over 30-90 minutes on day 1 Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses
ARM II Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 2 or 3 weeks for 4 courses Beginning 3 weeks later patients then receive paclitaxel as in arm I and bevacizumab IV over 30-90 minutes on day 1 Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses
ARM III Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab as in arm II Treatment repeats every 2 or 3 weeks for 4 courses Beginning 3 weeks later patients then receive paclitaxel as in arm I and bevacizumab as in arm II Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses Beginning 2 months later patients then receive bevacizumab IV over 30-90 minutes on day 1 Treatment with bevacizumab alone repeats every 3 weeks for 10 courses
In all arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 15 years
I To determine the disease-free survival of patients defined as invasive disease-free survival IFDS with lymph node positive and high risk lymph node negative breast cancer randomized to treatment with either doxorubicin doxorubicin hydrochloridecyclophosphamide plus placebo followed by paclitaxel AC placebo T placebo or the same chemotherapy regimen plus bevacizumab
SECONDARY OBJECTIVES
I To compare short-term 20-24 weeks versus long-term 50-54 weeks bevacizumab therapy
II To compare the overall survival III To evaluate toxicity IV To evaluate the association between outcomes in E5103 disease-free survival overall survival and toxicities and genotype derived from candidate single nucleotide polymorphisms and genome wide evaluations
V To compare the quality of life of breast cancer patients treated with ACpaclitaxel and bevacizumab or placebo in terms of physical symptoms physical functioning psychological state and social functioning over an 18 month period
VI To determine the impact of theoretical biomarker information on patients willingness to accept the toxicities of bevacizumab for the estimated potential benefit
VII To create a biospecimen repository including plasma serum and CellSearch cassettes containing circulating tumor cells CTC for evaluating determinants of late relapse including candidate biomarkers reflecting occult tumor burden eg CTCs and plasma tumor deoxyribonucleic acid DNA and host factors eg estrogen insulin-insulin-like growth factor IGF axis inflammation etc
VIII To create a biorepository of metastatic tumor samples in patients who have had a late relapse
IX To determine body mass index BMI and comorbidity burden in patients with operable breast cancer five or more years after diagnosis
X To determine whether there is a relationship between late relapse and BMI at diagnosis and at 5 years after diagnosis and whether BMI-associated inflammatory andor metabolic biomarkers are associated with early and late recurrence
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive doxorubicin hydrochloride intravenously IV cyclophosphamide IV over 20-30 minutes and placebo IV over 30-90 minutes on day 1 Treatment repeats every 2 or 3 weeks for 4 courses Beginning 3 weeks later patients then receive paclitaxel IV over 1 hour on days 1 8 and 15 and placebo IV over 30-90 minutes on day 1 Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses
ARM II Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 2 or 3 weeks for 4 courses Beginning 3 weeks later patients then receive paclitaxel as in arm I and bevacizumab IV over 30-90 minutes on day 1 Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses
ARM III Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab as in arm II Treatment repeats every 2 or 3 weeks for 4 courses Beginning 3 weeks later patients then receive paclitaxel as in arm I and bevacizumab as in arm II Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses Beginning 2 months later patients then receive bevacizumab IV over 30-90 minutes on day 1 Treatment with bevacizumab alone repeats every 3 weeks for 10 courses
In all arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 15 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 |
|---|---|---|---|
| NCI-2009-00561 | REGISTRY | None | None |
| CDR0000528955 | None | None | None |
| E5103 | None | None | None |
| ECOG-E5103 | None | None | None |
| 07-963 | None | None | None |
| E5103 | OTHER | None | None |
| E5103 | OTHER | None | None |
| U10CA180820 | NIH | None | None |
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |