Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02789657
Status:
COMPLETED
Last Update Posted:
2022-05-19
First Post:
2016-05-30
Brief Title:
Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Efficacy of Carboplatin and Paclitaxel With Trastuzumab and Pertuzumab wPCbTP and Switching to an Anthracycline-based Regimen AC in Non-responding Patients in Clinical Stage I-III HER2-positive Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-04
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:
Neoadjuvant therapy is given to breast cancer patients whose cancers are relatively large or have spread to lymph nodes or both The primary goal of this treatment is to prevent the cancer from coming back recurring elsewhere in the body but if it makes the cancer in the breast and lymph nodes shrink it might be easier to remove This could allow a patient to have a lumpectomy instead of a mastectomy and reduce the number of lymph nodes that the surgeon has to remove In some cases the neoadjuvant therapy works so well that it kills all of the cancer in the breast and lymph nodes This is referred to as a pathologic complete response pCR Patients who achieve a pCR have a much lower risk of the cancer recurring elsewhere in their bodies
Investigators arent sure which chemotherapy drugs work best with the HER2-targeted drugs and what combination of these drugs causes the fewest side effectsThus this study has two main goals
1 To find out if treatment with wPCbTP weekly paclitaxel and carboplatin given with trastuzumab and pertuzumab every 3 weeks leads to as many pCRs as TCHP in patients with HER2-positive breast cancer but has fewer side effects
2 To find out if HER2-positive patients whose cancers are not responding well after 12 weeks of wPCbTP get a better response when they are switched to a doxorubicin-containing regimen called AC for 4 cycles 8-12 weeks
Investigators arent sure which chemotherapy drugs work best with the HER2-targeted drugs and what combination of these drugs causes the fewest side effectsThus this study has two main goals
1 To find out if treatment with wPCbTP weekly paclitaxel and carboplatin given with trastuzumab and pertuzumab every 3 weeks leads to as many pCRs as TCHP in patients with HER2-positive breast cancer but has fewer side effects
2 To find out if HER2-positive patients whose cancers are not responding well after 12 weeks of wPCbTP get a better response when they are switched to a doxorubicin-containing regimen called AC for 4 cycles 8-12 weeks
Detailed Description:
See summary above
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