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

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ClinicalTrials.gov Identifier: NCT00237224
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : November 19, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Letrozole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole
Study Start Date : February 2003
Primary Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole
U.S. FDA Resources

Arm Intervention/treatment
Experimental: FEM345 Drug: Letrozole

Primary Outcome Measures :
  1. Identify Eg and/or Pg receptors in breast cancer patients in adjuvant treatment with tamoxifen for 4-5 years [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Identify the number of patients in adjuvant treatment with tamoxifen within 4-5 years or close to end this treatment time [ Time Frame: 4 months ]
  2. 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 [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237224

Novartis Investigative Site
Guadalajara, Zacatecas, México DF, Mexico
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00237224     History of Changes
Other Study ID Numbers: CFEM345EMX01
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs