Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT02214004
Status:
UNKNOWN
Last Update Posted:
2018-02-15
First Post:
2014-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
Sponsor:
Gangnam Severance Hospital
Organization:
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 mIU/ml
* 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 PS3/TS8 or modified Allred score more than PS4/TS7
* 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 mIU/ml
* 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 PS3/TS8 or modified Allred score more than PS4/TS7
* 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:
True
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?: