Viewing Study NCT00513292



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Last Modification Date: 2024-10-26 @ 9:35 AM
Study NCT ID: NCT00513292
Status: COMPLETED
Last Update Posted: 2019-01-23
First Post: 2007-08-06

Brief Title: Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients With HER-2 Positive Operable Breast Cancer
Status: COMPLETED
Status Verified Date: 2019-01
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 is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil epirubicin cyclophosphamide and trastuzumab in treating women with palpable breast cancer that can be removed by surgery 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 Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab
Detailed Description: PRIMARY OBJECTIVES

I The primary objective of this study is to compare the pathologic complete response rate pCR within the breast of a sequential regimen of concurrent weekly paclitaxel and trastuzumab followed by continued weekly trastuzumab administered concurrently with FEC-75 Arm 2 to the pCR rate of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab Arm 1

SECONDARY OBJECTIVES

I To estimate the cardiotoxicity of a sequential regimen of concurrent weekly paclitaxel and trastuzumab followed by continued weekly trastuzumab administered concurrently with FEC-75 followed postoperatively by q 3 week trastuzumab for a total duration of trastuzumab therapy through 52 weeks from the first dose Arm 2 and compare the cardiotoxicity to that of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab followed by q 3 week trastuzumab for a total duration of trastuzumab therapy through 52 weeks from the first dose Arm 1

II To compare the combined pCR rate in the breast and ipsilateral axilla obtained with the two regimens evaluated in this study

III To compare the clinical response rates cRR of the two regimens evaluated in this study

IV To compare the non-cardiac toxicity of the two regimens evaluated in this study

V To compare breast conservation rates achieved with the two regimens evaluated in this study

VI To evaluate disease-free survival and overall survival at 5 years post-randomization

VII To correlate pCR rate with potential molecular markers of response

OUTLINE Patients are stratified by clinical tumor size breast tumor size 2 cm and nodal metastases 2 cm vs breast tumor size 2 cm and nodal metastases 2 cm vs breast tumor size 2-4 cm any nodal status vs breast tumor size 4 cm any nodal status age 50 vs 50 and hormone receptor status estrogen receptor ER- and progesterone receptor PgR-negative vs ER- andor PgR-positive Patients are randomized to 1 of 2 treatment arms

ARM I Patients receive FEC comprising fluoroucacil intravenously IV epirubicin hydrochloride IV and cyclophosphamide IV on day 1 Treatment repeats every 21 days for 4 courses Beginning 21 days after completion of FEC patients receive paclitaxel IV once weekly and trastuzumab Herceptin IV once weekly for 12 weeks Within 6 weeks after completion of paclitaxel and trastuzumab patients undergo surgery Beginning 3-4 weeks after surgery patients receive trastuzumab IV once every 3 weeks for up to 52 weeks

ARM II Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks Beginning 7 days after completion of paclitaxel and trastuzumab patients receive FEC comprising fluoroucacil IV epirubicin IV and cyclophosphamide IV on day 1 Treatment repeats every 21 days for 4 courses Patients also receive trastuzumab IV once weekly for an additional 12 weeks Within 6 weeks after completion of FEC and trastuzumab patients undergo surgery Beginning 3-4 weeks after surgery patients receive trastuzumab as in arm I

After completion of study therapy patients are followed every 3 months for 1 year and then every 6 months for 4 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
U10CA012027 NIH CTEP httpsreporternihgovquickSearchU10CA012027
NCI-2009-00341 REGISTRY None None
CDR0000559039 None None None
ACOSOG-Z1041 None None None
Z1041 OTHER None None
ACOSOG-Z1041 OTHER None None