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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Letrozole

• Registration Number: NCT00237224
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-10-09
• Study First Submitted QC: 2005-10-09
• Study First Posted: 2005-10-12
• Primary Completion: 2007-02
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-18
• Last Update Posted: 2009-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FEM345	Letrozole	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇲🇽 Guadalajara, Zacatecas, México DF, Mexico