Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gangnam Severance Hospital
• Collaborators: Asan Medical Center; Samsung Medical Center; Seoul National University Hospital; Severance Hospital
• Treatments: Letrozole; Trastuzumab

Criteria

Inclusion Criteria:

• Invasive cancer (clinical stage IB-IIIC)

• 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

Exclusion Criteria:

• Inflammatory breast cancer

• Bilateral breast cancer

• Patients with previous breast cancer history

• Patients with previous breast cancer treatment: Generally include hormone therapy, chemotherapy, and radiotherapy)

• Patients having uncontrolled heart problems

• Ischemic heart disease within 6 months

• Congestive heart failure more than NYHA class II

• Unstable angina

• Clinically significant pericarditis

• Amyloid heart disease