Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382018
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2006-09-26
Brief Title:
S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment
Status:
COMPLETED
Status Verified Date:
2017-10
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 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better treatment When blood levels of tumor cells are high while receiving chemotherapy it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression
PURPOSE This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy
PURPOSE This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy
Detailed Description:
OBJECTIVES
Primary
Determine whether women with metastatic breast cancer and elevated circulating tumor cells CTCs 5 per 75 mL of whole blood after 3 weeks of first-line chemotherapy derive increased overall survival from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen
Determine whether these patients derive increased progression-free survival PFS from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen
Confirm previous findings that patients with 5 CTCs per 75 mL of whole blood on initial screening have longer median OS and PFS than patients with 5 CTCs per 75 mL of whole blood
Determine the prognostic value of sequentially collected CTC values in these patients
Compare toxicity between patients with and without elevated CTCs after 3 weeks of first-line chemotherapy AND between the two randomized treatment arms
Secondary
Compare the prognostic and predictive value of CTC number vs breast cancer tumor markers including CA 15-3 and carcinoembryonic antigen
Create a serum specimen bank for future biologic investigation
OUTLINE This is a partially blinded partially randomized multicenter study Patients are assigned to 1 of 3 groups based on circulating tumor cells CTCs after 1 course of chemotherapy
All patients undergo blood collection before their first dose of first-line chemotherapy to determine baseline CTC count Patients with 5 CTCs at baseline are assigned to group I Patients with 5 CTCs at baseline undergo a second blood draw on day 22 after completion of 1 course of chemotherapy Patients with 5 CTCs after completing 1 course of chemotherapy are assigned to group 2 Patients with 5 CTCs after completion of 1 course of chemotherapy are assigned to group 3
NOTE Chemotherapy may be initiated while waiting for the baseline CTC result
Group 1 low risk of early progression Patients continue to receive regular treatment without change at the discretion of the physician Patients are eligible for other first-line chemotherapy trials No further blood is collected
Group 2 moderate risk of early progression Patients continue to receive their current chemotherapy regimen without change
Group 3 high risk of early progression Patients are stratified according to HER-2 status positive vs negative and disease type bone-only vs measurable disease Patients are randomized to 1 of 2 treatment arms
Arm I Patients continue with their current chemotherapy regimen without change
Arm II Patients switch to a different chemotherapy regimen Selection of a new chemotherapy regimen is made by the patients doctor
Patients receiving hormonal therapy or biologic therapy and chemotherapy continue to receive the hormonal or biologic therapy unchanged regardless of CTC level
In groups 2 and 3 blood is collected periodically during chemotherapy and then at the completion of chemotherapy Samples are examined for CTCs via the CellSearch blood test Blood is also tested for CA 15-3 and carcinoembryonic antigen CEA
After completion of study therapy patients are followed for up to 5 years
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
Primary
Determine whether women with metastatic breast cancer and elevated circulating tumor cells CTCs 5 per 75 mL of whole blood after 3 weeks of first-line chemotherapy derive increased overall survival from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen
Determine whether these patients derive increased progression-free survival PFS from changing to an alternative chemotherapy regimen at the next course rather than waiting for clinical evidence of progressive disease before changing to an alternative chemotherapy regimen
Confirm previous findings that patients with 5 CTCs per 75 mL of whole blood on initial screening have longer median OS and PFS than patients with 5 CTCs per 75 mL of whole blood
Determine the prognostic value of sequentially collected CTC values in these patients
Compare toxicity between patients with and without elevated CTCs after 3 weeks of first-line chemotherapy AND between the two randomized treatment arms
Secondary
Compare the prognostic and predictive value of CTC number vs breast cancer tumor markers including CA 15-3 and carcinoembryonic antigen
Create a serum specimen bank for future biologic investigation
OUTLINE This is a partially blinded partially randomized multicenter study Patients are assigned to 1 of 3 groups based on circulating tumor cells CTCs after 1 course of chemotherapy
All patients undergo blood collection before their first dose of first-line chemotherapy to determine baseline CTC count Patients with 5 CTCs at baseline are assigned to group I Patients with 5 CTCs at baseline undergo a second blood draw on day 22 after completion of 1 course of chemotherapy Patients with 5 CTCs after completing 1 course of chemotherapy are assigned to group 2 Patients with 5 CTCs after completion of 1 course of chemotherapy are assigned to group 3
NOTE Chemotherapy may be initiated while waiting for the baseline CTC result
Group 1 low risk of early progression Patients continue to receive regular treatment without change at the discretion of the physician Patients are eligible for other first-line chemotherapy trials No further blood is collected
Group 2 moderate risk of early progression Patients continue to receive their current chemotherapy regimen without change
Group 3 high risk of early progression Patients are stratified according to HER-2 status positive vs negative and disease type bone-only vs measurable disease Patients are randomized to 1 of 2 treatment arms
Arm I Patients continue with their current chemotherapy regimen without change
Arm II Patients switch to a different chemotherapy regimen Selection of a new chemotherapy regimen is made by the patients doctor
Patients receiving hormonal therapy or biologic therapy and chemotherapy continue to receive the hormonal or biologic therapy unchanged regardless of CTC level
In groups 2 and 3 blood is collected periodically during chemotherapy and then at the completion of chemotherapy Samples are examined for CTCs via the CellSearch blood test Blood is also tested for CA 15-3 and carcinoembryonic antigen CEA
After completion of study therapy patients are followed for up to 5 years
PROJECTED ACCRUAL A total of 500 patients will be accrued for this study
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 |
|---|---|---|---|
| S0500 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |