Ignite Creation Date:
2024-05-06 @ 3:09 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02214004
Status:
UNKNOWN
Last Update Posted:
2018-02-15
First Post:
2014-08-05
Brief Title:
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
Sponsor:
Gangnam Severance Hospital
Organization:
Gangnam Severance Hospital
Study Overview
Official Title:
A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
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:
HERAKLES
Brief Summary:
The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and HER2-positive breast cancer
Detailed Description:
Eligibility criteria
Ages Eligible for Study 20 years
Invasive cancer clinical stage IB-IIIB
Measurable tumor larger than 1cm
ECOG status 0 or 1
Postmenopausal women
Age 55 years and amenorrhea
Age 55 years and amenorrhea for 12 months with FSH 30 mIUml
HER2 positive tumor
3 positive on IHC
2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
Estrogen receptor positive tumor
Positive ER expression with Allred score more than PS3TS8 or modified Allred score more than PS4TS7
Eligible cardiac function
Normal heard evaluated by ECG
Consider clinically non-significant arrythmia and ischemic change as normal
LVEF 55 measured by ECHO or MUGA scan
Outcome measures
Primary End-point
The rate of pathologic complete response pCR
No residual invasive cancer in breast
Secondary End-point
Clinical Response Rate
Safety profiles for the preoperative use of concurrent trastuzumab and letrozole
The rate of breast conservative surgery
Total pathologic complete response tpCR
No residual invasive cancer in breast and ipsilateral axilla
Analysis of biomarkers based on baseline specimen and residual tumor
Ki67 expression
cDNA microarray gene expression profiling
Association between clinical response rate and circulating tumor cells CTCs
CTCs are measured by CytoGen SEOUL KOREA
Ages Eligible for Study 20 years
Invasive cancer clinical stage IB-IIIB
Measurable tumor larger than 1cm
ECOG status 0 or 1
Postmenopausal women
Age 55 years and amenorrhea
Age 55 years and amenorrhea for 12 months with FSH 30 mIUml
HER2 positive tumor
3 positive on IHC
2 positive on IHC with HER2 gene amplification on FISH or SISH using a single-probe or dual-probe
Estrogen receptor positive tumor
Positive ER expression with Allred score more than PS3TS8 or modified Allred score more than PS4TS7
Eligible cardiac function
Normal heard evaluated by ECG
Consider clinically non-significant arrythmia and ischemic change as normal
LVEF 55 measured by ECHO or MUGA scan
Outcome measures
Primary End-point
The rate of pathologic complete response pCR
No residual invasive cancer in breast
Secondary End-point
Clinical Response Rate
Safety profiles for the preoperative use of concurrent trastuzumab and letrozole
The rate of breast conservative surgery
Total pathologic complete response tpCR
No residual invasive cancer in breast and ipsilateral axilla
Analysis of biomarkers based on baseline specimen and residual tumor
Ki67 expression
cDNA microarray gene expression profiling
Association between clinical response rate and circulating tumor cells CTCs
CTCs are measured by CytoGen SEOUL KOREA
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