Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: September 24, 2007
Last updated: April 18, 2012
Last verified: April 2012
This study will assess optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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:
| Primary Completion Date:
||July 2002 (Final data collection date for primary outcome measure)
Other Name: FEM345
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- Patients after menopause
- Tumor measurable by clinical examination, mammography and ultrasound
- Adequate bone marrow, renal and hepatic function
- A life expectancy of at least 6 months.
- Prior treatment with aromatase inhibitors or antiestrogens.
- 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).
- Patients with tumors in both breasts, evidence of inflammatory breast cancer or distant metastasis
- Patients who are eligible for breast conserving surgery.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535418
No publications provided by Novartis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2007
||April 18, 2012
||Germany: German Institute of Medical Documentation and Information
Keywords provided by Novartis:
Primary hormone receptor positive
breast cancer in postmenopausal women
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action