Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
This study aimed at evaluating following:
1. Validity Assessment:
1. Primary End Point: To evaluate 5-year diseae free survival rate after Letrozole
treatment according to the estrogen receptor expression in postmenopausal women
2. Secondary End Point: To evaluate overall survival rate(OS) and Time to distance
recurrence(TTDR) after Hormonal therapy in postmenopausal women with hormone
receptor positive breast cancer
2. Safety Assessment: To evaluate all adverse events including serious adverse events
after Letrozole treatment.
Observational
Observational Model: Case Control, Time Perspective: Prospective
Disease free survival
the first 5 years after enrollment
Yes
Joon Jeong, MD
Principal Investigator
Department of Surgery, Gangnam Severance Hospital, South Korea
Korea: Food and Drug Administration
KBCSG006
NCT01069211
January 2010
January 2017
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