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

NCT00237224 | Completed Phase 4

• 1 other identifier: CFEM345EMX01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer, ER and/or PgR positive, Letrozole

Outcome Measures

Primary Outcomes (1)

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

  4 months

Secondary Outcomes (2)

• 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

Study Arms (1)

FEM345

EXPERIMENTAL

Drug: Letrozole

Interventions

Letrozole DRUG

FEM345

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).
• Tumor measurable by clinical examination, mammography and ultrasound.

You may not qualify if:

• Prior treatment with letrozole or tamoxifen.
• Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated).
• Patients with unstable, angina, or uncontrolled cardiac disease (e.g. Class III or IV New York Heart association's Functional Classification).
• Patients with bilateral breast tumors
• Patients who are eligible for breast conserving surgery
• Evidence of inflammatory breast cancer or distant metastasis.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Guadalajara, Zacatecas, México DF, Mexico

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 9, 2005
• First Posted: October 12, 2005
• Study Start: February 1, 2003
• Primary Completion: February 1, 2007
• Last Updated: November 19, 2009

Record last verified: 2009-11

Locations

ME (1)