MedTrace Logo

Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer

NCT01622361 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2013-09-30

No results posted yet for this study

Summary

The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy versus GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and HER2 negative, lymph node positive, primary breast cancer in premenopausal women.

Conditions

Interventions

DRUG

Adriamycin+Cyclophosphamide>Docetaxel

1. Adriamycin 60mg/m2 + Cyclophosphamide 600mg/m2 * Route: by slow intravenous bolus * Schedule: every 3weeks for 4 cycle 2. Docetaxel 75mg/m2 * Route: intravenous as per local practice * Schedule: every 3weeks for 4 cycle

DRUG

GnRHa with Tamoxifen

1. Goserelin(GnRHa) 3.6mg * Route: subcutaneously under the abdominal skin * Schedule: every 4weeks for 6cycles (period of 34 days between 2 administrations must not be exceeded) 2. Tamoxifen 20mg/day * Route: Oral * Schedule: everyday

Sponsors & Collaborators

  • Korean Breast Cancer Study Group

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • South Korea

Study Locations

More Related Trials

Entities

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 NCT01622361 on ClinicalTrials.gov