Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

Phase 4

Completed

• Conditions: Locally Advanced Breast Cancer
• Interventions: Drug: Letrozole

• Registration Number: NCT00237133
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-10-09
• Study First Submitted QC: 2005-10-09
• Study First Posted: 2005-10-12
• Primary Completion: 2009-01
• Study Completion: 2009-01-21
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole	Letrozole	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of Letrozole	frequency and severity of the clinical adverse events

Trial Locations

Locations (1)

Novartis Investigative Site; 🇧🇷 Vitoria/ES, Brazil