Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women

Breast Cancer Clinical Trial

— LETTER  

Official title:

Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01069211
• Other study ID #: KBCSG006
• Status: Recruiting
• Phase: Phase 4
• First received: February 14, 2010
• Last updated: May 10, 2011
• Start date: January 2010
• Est. completion date: January 2017

Study information

• Verified date: May 2011
• Source: Korean Breast Cancer Study Group
• Contact: Ku Sang Kim, MD
• Phone: 82-31-219-5200
• Email: ideakims[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 876
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Joon Jeong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korean Breast Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival		the first 5 years after enrollment	Yes
Secondary	Adverse effect		the first 5 years after enrollment	Yes
Secondary	Overall Survival		the first 5 years after enrollment	Yes
Secondary	Time to Distant Recurrence (TTDR)		the first 5 years after enrollment	Yes