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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01069211

Acronym

LETTER

Enrollment

876

Registered

2010-02-17

Start date

2010-01-31

Completion date

2017-01-31

Last updated

2011-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Letrozole, postmenopause, hormone 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Disease free survival	the first 5 years after enrollment

Secondary

Measure	Time frame
Adverse effect	the first 5 years after enrollment
Overall Survival	the first 5 years after enrollment
Time to Distant Recurrence (TTDR)	the first 5 years after enrollment

Countries

South Korea

Contacts

Primary ContactKu Sang Kim, MD

ideakims@gmail.com82-31-219-5200

Outcome results