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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237224
• Other study ID #: CFEM345EMX01
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2005
• Last updated: November 18, 2009
• Start date: February 2003

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole

Locations

Country	Name	City	State
Mexico	Novartis Investigative Site	Guadalajara	Zacatecas, México DF

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify Eg and/or Pg receptors in breast cancer patients in adjuvant treatment with tamoxifen for 4-5 years		4 months	No
Secondary	Identify the number of patients in adjuvant treatment with tamoxifen within 4-5 years or close to end this treatment time		4 months	No
Secondary	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	No