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Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women

NCT02214004 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2018-02-15

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Gangnam Severance Hospital

    lead OTHER

Principal Investigators

  • Joon Jeong, M.D.,Ph.D. · Gangnam Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-03-31
Completion
2019-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02214004 on ClinicalTrials.gov