Status:
COMPLETED
Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
45-80 years
Phase:
PHASE4
Brief Summary
To evaluate safety and efficacy (measured by clinical tumor response) of letrozole daily dose, 2.5 mg in postmenopausal patients with primary (untreated) breast cancer.
Eligibility Criteria
Inclusion
- Postmenopausal woman able to comply with the protocol requirements with primary invasive breast cancer, histologically 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.
- Clinical stage \*T2, T3, T4a,b,c, N0, 1 or 2, M0
- Clinical stage T2 tumors which in the Investigators opinion would not be eligible for breast-conserving surgery.
- Post menopausal status defined by one of the following:
- No spontaneous menses for at least 1 year, in women \> 55 years.
- Spontaneous menses within the past 1 year but amenorrhoeic in women ≤ 55 years (e.g. spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (LH y FSH levels \> 40 IU/L) or postmenopausal estradiol levels (\< 5 ng/dl) or according to the definition of "postmenopausal range" for the laboratory involved.
- Bilateral oophorectomy. (Prior to the diagnosis of breast cancer).
- Tumor measurable by clinical examination, mammography and ultrasound.
Exclusion
- Prior treatment with letrozole or tamoxifen.
- Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated).
- Patients with unstable, angina, or uncontrolled cardiac disease (e.g. Class III or IV New York Heart association's Functional Classification).
- Patients with bilateral breast tumors
- Patients who are eligible for breast conserving surgery
- Evidence of inflammatory breast cancer or distant metastasis.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00237224
Start Date
February 1 2003
Last Update
November 19 2009
Active Locations (1)
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1
Novartis Investigative Site
Guadalajara, Zacatecas, México DF, Mexico