Clinical trial NCT01069211: Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women
Official title: Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast cancer, Letrozole
postmenopause
hormone receptor positive breast cancer
Lead sponsor: Korean Breast Cancer Study Group
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 876
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited into the study are postmenopausal women with estrogen receptor positive breast cancer.

Brief summary: The purpose of this study is to assess clinical outcomes after Letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with estrogen receptor(+) and/or progesterone receptor(+)
2. Postmenopausal state was defined the following conditions, at least one of a, b

   1. Serum FSH ≥ 30 mIU/mL and Amenorrhea ≥ 1 year for below 55 years, over than 55 years
   2. Bilateral oophorectomy
3. Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
4. WHO(ECOG) performance status 0-2
5. Adequate haematological function, renal function, hepatic function.
6. No evidence of metastasis.

Exclusion Criteria:

1. Metachronous bilateral breast cancer.
2. Metastatic breast cancer (stage IV)
3. Other hormone therapy and Hormonal replacement therapy given within the previous 4 weeks, except for Estring, Vagifem, Estrogen Cream.
4. Patients with Child-Pugh grade C, serum creatinine\>2xUNL
5. Patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.

Primary outcomes:
measure: Disease free survival
timeFrame: the first 5 years after enrollment
Secondary outcomes:
measure: Adverse effect
timeFrame: the first 5 years after enrollment
measure: Overall Survival
timeFrame: the first 5 years after enrollment
measure: Time to Distant Recurrence (TTDR)
timeFrame: the first 5 years after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Joon Jeong
Study officials:
affiliation: Department of Surgery, Gangnam Severance Hospital, South Korea
name: Joon Jeong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahn SG, Nam SJ, Ahn SH, Jung Y, Park HK, Lee SJ, Kang SS, Han W, Park KH, Park YL, Lee J, Youn HJ, Kim JH, Yoo Y, Song JY, Ko BK, Gwak G, Chung MS, Kim SY, Cho SH, Kim D, Chang MC, Moon BI, Kim LS, Kim SJ, Park MH, Kim TH, Cho J, Lim CW, Bae YT, Gong G, Bae YK, Lee A, Jeong J. Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006). J Breast Cancer. 2021 Apr;24(2):164-174. doi: 10.4048/jbc.2021.24.e17. Epub 2021 Mar 25.