Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2006-10-31

Brief Summary

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To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.

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Detailed Description

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Conditions

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Postmenopausal Women With Advanced Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letrozole

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Interventions

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Letrozole

Intervention Type DRUG

Other Intervention Names

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FEM345

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically documented breast cancer.
* Patients with hormone receptor (ER and/or PgR) status of positive or unknown
* Patients who have been amenorrheic for the preceding 12 months or more.
* Patients who are 20 years or older and younger than 75 years.
* Patients with a history of postoperative adjuvant therapy or a history of endocrine therapy with tamoxifen for the treatment of progression or recurrence of the lesion. The endocrine therapy, however, should not exceed one regimen.
* Patients with progressing lesions.
* Patients with sufficient organ function to evaluate the safety
* Patients whose performance status (PS) is classified in 0～2.
* Patients who have no residual effects from previous treatments

Exclusion Criteria

* Patients with other concurrent or previous malignant disease (excluding uterine carcinoma in-situ).
* Patients with hypercalcemia and uncontrollable cardiac disease (including a history of serious cardiac disease)
* Patients who have previously received aromatase inhibitor.
* Patients who have lymphangitis-type lung metastasis or symptomatic brain metastasis.

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No