Treatment of Locally Advanced Breast Cancer With Letrozole 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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-01-21

Brief Summary

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Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)

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Detailed Description

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Conditions

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Locally 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

1 tablet of Letrozole 2.5 mg orally adminnistered once a day

Interventions

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Letrozole

1 tablet of Letrozole 2.5 mg orally adminnistered once a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Postmenopausal women
2. Primary locally invasive breast cancer
3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with \> 10% positive malignant epithelial cells.
4. Post menopausal status
5. Tumor measurable by clinical examination, mammography and ultrasound

Exclusion Criteria

1. Prior treatment with letrozole or tamoxifen.
2. Patients with bilateral breast tumors
3. Patients who are eligible for breast conserving surgery
4. Evidence of inflammatory breast cancer or distant metastasis.
5. Other concurrent malignant disease
6. Concomitant anti-cancer treatments such as chemotherapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No