PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Locally Advanced Breast Cancer
Both
Locally Advanced Breast Cancer
Trial Information
PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of Letrozole
Outcome Time Frame:
frequency and severity of the clinical adverse events
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Brazil: National Committee of Ethics in Research
Study ID:
CFEM345EBR01
NCT ID:
NCT00237133
Start Date:
March 2003
Completion Date:
Related Keywords:
- Locally Advanced Breast Cancer
- Breast cancer,
- Letrozole,
- Hormonal receptors
- Breast Neoplasms
Name | Location |
|---|
