Clinical trial NCT00237224: Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
Official title: Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast Cancer, ER and/or PgR positive, Letrozole
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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/exclusion criteria may apply.

Primary outcomes:
measure: Identify Eg and/or Pg receptors in breast cancer patients in adjuvant treatment with tamoxifen for 4-5 years
timeFrame: 4 months
Secondary outcomes:
measure: Identify the number of patients in adjuvant treatment with tamoxifen within 4-5 years or close to end this treatment time
timeFrame: 4 months
measure: 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
timeFrame: 4 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Zacatecas, México DF
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: