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Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole

Phase 4
45 Years
80 Years
Not Enrolling
Breast Cancer

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Trial Information

Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Identify Eg and/or Pg receptors in breast cancer patients in adjuvant treatment with tamoxifen for 4-5 years

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Mexico: Federal Commission for Protection Against Health Risks

Study ID:




Start Date:

February 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer, ER and/or PgR positive, Letrozole
  • Breast Neoplasms