eoadjuvant hormone therapy for postmenopausal women with ER and/or PgR positive primary breast cancer: A multi-center study to determine the optimum length of treatment with Femara (letrozole 2.5mg daily) on tumour regression to permit breast conserving surgery.

ovartis Pharmaceuticals UK Ltd0 sitesAugust 24, 2005

ConditionsPostmenopausal women with ER and/or PgR positive primary breast cancer

DrugsFemara

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postmenopausal women with ER and/or PgR positive primary breast cancer
Sponsor: ovartis Pharmaceuticals UK Ltd
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 24, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

ovartis Pharmaceuticals UK Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Postmenopausal women able to comply with the protocol requirements with primary invasive breast cancer, histologically confirmed by core needle biopsy (see appendix I: Preparation of core biopsies), whose tumours are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with \> 30% positive malignant epithelial cells. Where tumours are bilateral, the reference side should be that with the larger or largest tumour at baseline.
•2\. Clinical Stage T2 or \>T2 tumours which in the investigators opinion would not be eligible for breast\-conserving surgery. The nodal status will be evaluated by palpation and/or ultrasound.
•3\. Post menopausal status defined by one of the following:
•Women with an intact uterus and
•\= 55 years of age OR
•\< 55 years of age without menses for the last 5 years OR
•\< 55 years of age and has not had menses for at least the last 12 months (but has had menses in the last 5 years) and has postmenopausal levels of FSH (according to the postmenopausal range of the individual laboratory, and performed at least four weeks after stopping HRT/oral contraceptives).
•OR In the case of women without an intact uterus and
•\= 55 years of age OR
•\>55 years of age and postmenopausal levels of FSH (according to the postmenopausal range of the individual laboratory, and performed at least four weeks after stopping HRT/oral contraceptives)

Exclusion Criteria

•1\. Multifocal disease
•2\. Prior treatment with aromatase inhibitors or antiestrogens, or known hypersensitivity to these compounds.
•3\. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hyper\- or hypothyroidism, Cushing´s Syndrome, Addison´s disease (treated or untreated).
•4\. Patients with unstable angina, uncontrolled cardiac disease (e.g. Class III or IV New York Heart Association's Functional Classification).
•5\. Patients who are eligible for breast conserving surgery.
•6\. Evidence of inflammatory breast cancer or distant metastasis.
•7\. Other concurrent malignant disease with the exception of cone\-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin´s disease or NHL, provided 5 years have elapsed from completion of therapy, and there has been no recurrence.
•8\. Concomitant anti\-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers (BRM’s), endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. Bisphosphonate therapy for osteoporosis is NOT excluded, and can be continued as concomitant therapy. Patients who have received HRT will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.
•9\. Concomitant treatment with steroids, e.g. glucocorticoids for indications other than cancer, except aerosol for obstructive airways diseases and steroid injection to the joints for treatment of inflammation.
•10\. Other investigational drugs within the past 30 days and the concomitant use of investigational drugs.