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Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers

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ClinicalTrials.gov Identifier: NCT00535418
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 5, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will assess optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Letrozole Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pre-operative Hormone Therapy for Postmenopausal Women With ER and/or PgR Positive Breast Cancer: An Uncontrolled Phase IIb/III Trial to Assess Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers
Study Start Date : June 2000
Primary Completion Date : July 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Letrozole Drug: Letrozole
Other Name: FEM345

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Female Breast Cancer patients with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive (Clinical Stage *T2, T3, T4a,b,c, N0, M0)
  2. Patients after menopause
  3. Tumor measurable by clinical examination, mammography and ultrasound
  4. Adequate bone marrow, renal and hepatic function
  5. A life expectancy of at least 6 months.

Exclusion criteria:

  1. Prior treatment with aromatase inhibitors or antiestrogens.
  2. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing´s Syndrome, Addison´s disease (treated or untreated), Patients with unstable angina, uncontrolled cardiac disease (e.g. Class II or IV New York Heart Association's Functional Classification).
  3. Patients with tumors in both breasts, evidence of inflammatory breast cancer or distant metastasis
  4. Patients who are eligible for breast conserving surgery.
  5. Concomitant anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers (BRM's), endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. Patients who have received HRT will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.

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): NCT00535418

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00535418     History of Changes
Other Study ID Numbers: CFEM345EDE01
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast cancer
neoadjuvant treatment
treatment duration
Primary hormone receptor positive
breast cancer in postmenopausal women

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