Spots Global Cancer Trial Database for Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer

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We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: 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

Study ID: NCT01622361

Conditions

Breast Cancer

Interventions

Adriamycin+Cyclophosphamide>Docetaxel

GnRHa with Tamoxifen

Study Description

Brief 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