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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

876 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ER expression : Low

Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 3 or 4 point of total Allred score.

No interventions assigned to this group

ER expression : Intermediate

Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 5 or 6 point of total Allred score.

No interventions assigned to this group

ER expression : High

Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 7 or 8 point of total Allred score.

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No