Breast Cancer
Conditions
Keywords
Breast Cancer, ER and/or PgR positive, Letrozole
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.
Interventions
DRUGLetrozole
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. 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). 4. Tumor measurable by clinical examination, mammography and ultrasound.
Exclusion criteria
1. Prior treatment with letrozole or tamoxifen. 2. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated). 3. Patients with unstable, angina, or uncontrolled cardiac disease (e.g. Class III or IV New York Heart association's Functional Classification). 4. Patients with bilateral breast tumors 5. Patients who are eligible for breast conserving surgery 6. Evidence of inflammatory breast cancer or distant metastasis. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify Eg and/or Pg receptors in breast cancer patients in adjuvant treatment with tamoxifen for 4-5 years | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Identify the number of patients in adjuvant treatment with tamoxifen within 4-5 years or close to end this treatment time | 4 months |
| Determine the relation of positive Eg / Pg receptors vs negative (unknown) Eg / Pg receptors and the only selection criteria for the adjuvant treatment with tamoxifen is postmenopause status | 4 months |
Countries
Mexico
Outcome results
None listed