Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02297230
Status:
TERMINATED
Last Update Posted:
2018-10-15
First Post:
2014-10-27
Brief Title:
Locally Advanced Breast Cancer Individualized Treatment Based On Tumor Molecular Characteristics
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Locally Advanced Breast Cancer Individualized Treatment Based On Tumor Molecular Characteristics
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Left Institution prior to reaching accrual goal and analyzing data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Paclitaxel 30 mgm2 twiceweek Trastuzumab 4mgkg loading dose then 2 mgkg weekly and Concurrent RT to start within one week from first dose of PaclitaxelTrastuzumab to breast supraclavicular axillary fields 45 Gy 18 Gyfraction 14 Gy 2 Gyfraction to the primary tumor At the end of chemo-radiation Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total
Surgery Patients will undergo lumpectomy and axillary node dissection or modified radical mastectomy within two months following discontinuation of pre-operative systemic therapy contingent upon recovery of skin toxicity Pathologic response will be evaluated at the time of surgery Additional tissue samples will be collected from the surgical specimen for assessment of tumor molecular characteristics
All patients may undergo four cycles of post-operative Standard AC doxorubicin 60 mgm2 cyclophosphamide 600 mgm2 or four cycles of post-operative epirubicin and Cyclophosphamide epirubicin 100 mgm2 cyclophosphamide 600 mgm2 if doxorubicin is not available Tamoxifen as well or any alternative antihormonal therapy may be prescribed for five years for patients with hormone receptor positive tumors Herceptin Trastuzumab will be prescribed for a total of 1 year since first dose as per standard of care
Surgery Patients will undergo lumpectomy and axillary node dissection or modified radical mastectomy within two months following discontinuation of pre-operative systemic therapy contingent upon recovery of skin toxicity Pathologic response will be evaluated at the time of surgery Additional tissue samples will be collected from the surgical specimen for assessment of tumor molecular characteristics
All patients may undergo four cycles of post-operative Standard AC doxorubicin 60 mgm2 cyclophosphamide 600 mgm2 or four cycles of post-operative epirubicin and Cyclophosphamide epirubicin 100 mgm2 cyclophosphamide 600 mgm2 if doxorubicin is not available Tamoxifen as well or any alternative antihormonal therapy may be prescribed for five years for patients with hormone receptor positive tumors Herceptin Trastuzumab will be prescribed for a total of 1 year since first dose as per standard of care
Detailed Description:
Locally Advanced Breast Cancer T greater than 30 cm HER-2neu positive Patients with ipsilateral supraclavicular nodes are eligible Patients with inflammatory breast cancer or distant metastases are excluded Patients with prior treatment for their breast cancer are excluded Patients must have adequate laboratory parameters and normal cardiac function Patients receive Concurrent Radiation therapy with either Capecitabine Paclitaxel and Herceptin Capecitabine Xeloda 750 mgm2 twicedaily given orally Treatment should begin on day 1 of radiation therapy The two doses should be taken about 30 minutes after eating eg after breakfast and after dinner Treatment will be given for 10 weeks for 6 weeks during radiation and for 4 weeks after radiationTrastuzumab Herceptin will begin on day 1 of radiation therapy and be administered weekly The first dose will be 4mgkg given IV over 90 minutes Subsequent weekly doses will be 2 mgkgweek IV over 30 minutes Paclitaxel 30 mgm2 twice per week given IV over 1 hour Treatment will be initiated during the first week of radiation therapy and should be administered on a MondayThursday or TuesdayFriday schedulePaclitaxel 30 mgm2 twice per week given IV over 1 hour Treatment will be initiated during the first week of radiation therapy and should be administered on a MondayThursday or TuesdayFriday scheduleTrastuzumab Herceptin treatment will be administered weekly together with one of the two weekly doses of Paclitaxel The first dose will be 4mgkg given IV over 90 minutes Subsequent weekly doses will be given at a dose of 2 mgkgweek IV over 30 minutes The treatment with Trastuzumab will continue weekly after the completion of the radiation treatment until surgery and thereafter as per standard of care up to 1 year post surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None