NCT02214004

Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women

A Phase II Trial of Preoperative HER2 Targeting and Endocrine Therapy in Postmenopausal Women With HER2 and HR Positive Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)"

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	\- Eight times IV administration of trastuzumab per 3 weeks * Trastuzumab 8mg/kg on Day 1 of Cycle 1 * Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8
DRUG	Letrozole	\- Daily letrozole 2.5 mg/day for 24 weeks

Timeline

• Start date: 2015-03-01
• Primary completion: 2019-03-01
• Completion: 2019-06-01
• First posted: 2014-08-12
• Last updated: 2018-02-15

Locations

14 sites across 1 country: South Korea