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

The following info and data is provided "as is" to help patients around the globe.
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

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

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Asan Medical Center, Seoul, Songpa-gu, Korea, Republic of

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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