Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096291
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2004-11-09
Brief Title:
Neoadjuvant Chemotherapy Using Doxorubicin and Paclitaxel in Treating Women With Large Breast Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Neoadjuvant Chemotherapy in Palpable Breast Cancer Evaluation of Physiologic Radiologic and Molecular Markers in Predicting Response
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:
RATIONALE Drugs used in chemotherapy such as doxorubicin and paclitaxel work in different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery
PURPOSE This randomized phase II trial is comparing two different regimens of doxorubicin and paclitaxel to see how well they work in treating women who are undergoing surgery for breast cancer
PURPOSE This randomized phase II trial is comparing two different regimens of doxorubicin and paclitaxel to see how well they work in treating women who are undergoing surgery for breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether tumors in women with palpable invasive breast cancer with wild type p53 are more sensitive to doxorubicin than to paclitaxel when given as sequential single-agent neoadjuvant chemotherapy
Determine whether tumors with inactivated p53 are more sensitive to paclitaxel than to doxorubicin when given as sequential single-agent neoadjuvant chemotherapy in these patients
Secondary
Correlate other biological markers physiological and molecular with tumor response in patients treated with these regimens
Determine changes in these biological markers during and after neoadjuvant chemotherapy in these patients
Compare breast MRI in terms of assessing tumor response with physical exam mammogram and ultrasound in patients treated with these regimens
Determine whether there are MRI indicators eg tumor morphology or lesion enhancement that are predictive of response in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor size 5 cm vs 3-5 cm and presence of palpable regional lymph nodes yes vs no Patients are randomized to 1 of 2 treatment arms
All patients undergo biopsy bilateral mammogram MRI ultrasound blood marker molecular gene microarrays and functional p53 status and physiologic studies before initiation of neoadjuvant chemotherapy Some of these studies are repeated after completion of treatment with the first chemotherapeutic agent and after completion of treatment with the second chemotherapeutic agent as outlined below
Arm I Patients receive doxorubicin IV on days 1 15 29 and 43 Patients with no residual tumor indicated by clinical evaluation and radiologic studies after completion of doxorubicin undergo definitive surgery After surgery patients receive paclitaxel IV over 1 hour on days 1 8 15 22 29 36 43 50 and 57
Patients with residual tumor 2 cm after completion of doxorubicin undergo 8-12 core needle biopsies Patients with residual tumor 2 cm after completion of doxorubicin undergo 4-6 core needle biopsies After core needle biopsies patients receive paclitaxel as above
Arm II Patients receive paclitaxel IV over 1 hour on days 1 8 15 22 29 36 43 50 and 57 Patients with no residual tumor indicated by clinical evaluation and radiologic studies after completion of paclitaxel undergo definitive surgery After surgery patients receive doxorubicin IV on days 1 15 29 and 43
Patients with residual tumor 2 cm after completion of paclitaxel undergo 8-12 core needle biopsies Patients with residual tumor 2 cm after completion of paclitaxel undergo 4-6 core needle biopsies After core needle biopsies patients receive doxorubicin as above
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Samples from core needle biopsies are analyzed by microarray analysis for gene expression profiles
Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study within 4-5 years
Primary
Determine whether tumors in women with palpable invasive breast cancer with wild type p53 are more sensitive to doxorubicin than to paclitaxel when given as sequential single-agent neoadjuvant chemotherapy
Determine whether tumors with inactivated p53 are more sensitive to paclitaxel than to doxorubicin when given as sequential single-agent neoadjuvant chemotherapy in these patients
Secondary
Correlate other biological markers physiological and molecular with tumor response in patients treated with these regimens
Determine changes in these biological markers during and after neoadjuvant chemotherapy in these patients
Compare breast MRI in terms of assessing tumor response with physical exam mammogram and ultrasound in patients treated with these regimens
Determine whether there are MRI indicators eg tumor morphology or lesion enhancement that are predictive of response in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to tumor size 5 cm vs 3-5 cm and presence of palpable regional lymph nodes yes vs no Patients are randomized to 1 of 2 treatment arms
All patients undergo biopsy bilateral mammogram MRI ultrasound blood marker molecular gene microarrays and functional p53 status and physiologic studies before initiation of neoadjuvant chemotherapy Some of these studies are repeated after completion of treatment with the first chemotherapeutic agent and after completion of treatment with the second chemotherapeutic agent as outlined below
Arm I Patients receive doxorubicin IV on days 1 15 29 and 43 Patients with no residual tumor indicated by clinical evaluation and radiologic studies after completion of doxorubicin undergo definitive surgery After surgery patients receive paclitaxel IV over 1 hour on days 1 8 15 22 29 36 43 50 and 57
Patients with residual tumor 2 cm after completion of doxorubicin undergo 8-12 core needle biopsies Patients with residual tumor 2 cm after completion of doxorubicin undergo 4-6 core needle biopsies After core needle biopsies patients receive paclitaxel as above
Arm II Patients receive paclitaxel IV over 1 hour on days 1 8 15 22 29 36 43 50 and 57 Patients with no residual tumor indicated by clinical evaluation and radiologic studies after completion of paclitaxel undergo definitive surgery After surgery patients receive doxorubicin IV on days 1 15 29 and 43
Patients with residual tumor 2 cm after completion of paclitaxel undergo 8-12 core needle biopsies Patients with residual tumor 2 cm after completion of paclitaxel undergo 4-6 core needle biopsies After core needle biopsies patients receive doxorubicin as above
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Samples from core needle biopsies are analyzed by microarray analysis for gene expression profiles
Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study within 4-5 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 |
|---|---|---|---|
| P50CA089393 | NIH | None | None |
| P30CA006516 | NIH | None | None |
| DFCI-99278 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |