NCT01622361

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

A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant Study of Chemotherapy Versus Endocrine Therapy in Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. Primary objective : Response Rate-MRI and/or Caliper 2. Secondary objectives * Pathologic complete response * Rate of conservation surgery * Ki-67 changes and its relationship to treatment response * Length of time to maximum response within the treatment period * Tolerability of two treatments * Disease-free survival(DFS) * Overall survival

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2012-06-19
• Last updated: 2013-09-30

Locations

1 site across 1 country: South Korea