Status:
COMPLETED
Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Locally Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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)
Eligibility Criteria
Inclusion
- Postmenopausal women
- Primary locally invasive breast cancer
- 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.
- Post menopausal status
- Tumor measurable by clinical examination, mammography and ultrasound
Exclusion
- Prior treatment with letrozole or tamoxifen.
- Patients with bilateral breast tumors
- Patients who are eligible for breast conserving surgery
- Evidence of inflammatory breast cancer or distant metastasis.
- Other concurrent malignant disease
- Concomitant anti-cancer treatments such as chemotherapy
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00237133
Start Date
March 1 2003
End Date
January 21 2009
Last Update
February 24 2017
Active Locations (11)
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1
Novartis Investigative Site
Barretos - SP, Brazil
2
Novartis Investigative Site
Florianopolis - SC, Brazil
3
Novartis Investigative Site
Fortaleza/CE, Brazil
4
Novartis Investigative Site
Goiania/GO, Brazil