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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00237224
First received: October 9, 2005
Last updated: November 18, 2009
Last verified: November 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of Postmenopausal Women With ER and /or PgR Positive Breast Cancer Treated With Letrozole

Resource links provided by NLM:


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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2003
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FEM345 Drug: Letrozole

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00237224     History of Changes
Other Study ID Numbers: CFEM345EMX01
Study First Received: October 9, 2005
Last Updated: November 18, 2009
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

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

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

ClinicalTrials.gov processed this record on August 25, 2014