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Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
This study has been terminated.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00237224
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Letrozole
Phase IV

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Letrozole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Identify the number of patients in adjuvant treatment with tamoxifen within 4-5 years or close to end this treatment time
  • 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

Estimated Enrollment: 280
Study Start Date: February 2003
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237224

Locations
Mexico, Zacatecas, México DF
Monterrey
Guadalajara, Baja California Sur, Zacatecas, México DF, Mexico
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Study ID Numbers: CFEM345EMX01
Study First Received: October 9, 2005
Last Updated: August 16, 2006
ClinicalTrials.gov Identifier: NCT00237224  
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Novartis:
Breast Cancer, ER and/or PgR positive, Letrozole

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009