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Clinical Trial 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.


Clinical Trial 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)" ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02214004
Study type Interventional
Source Gangnam Severance Hospital
Contact Joon Jeong, M.D.,Ph.D.
Phone 82220193370
Email gsjjoon@yuhs.ac
Status Recruiting
Phase Phase 2
Start date March 2015
Completion date June 2019

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