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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Letrozole

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Zacatecas, México DF
    • Guadalajara, Zacatecas, México DF, Mexico
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FEM345	Drug: Letrozole

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: October 9, 2005
• First Submitted That Met QC Criteria: October 9, 2005
• First Posted (Estimate): October 12, 2005

Study Record Updates

• Last Update Posted (Estimate): November 19, 2009
• Last Update Submitted That Met QC Criteria: November 18, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Breast Cancer, ER and/or PgR positive, Letrozole
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: CFEM345EMX01