Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer
NCT ID: NCT00330317
Last Updated: 2017-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2006-02-28
2010-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Letrozole
letrozole
2.5mg letrozole once-daily
Interventions
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letrozole
2.5mg letrozole once-daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. Postmenopausal 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 have not had menses for at least the last 12 months (but have had menses in the last 5 years) and have postmenopausal levels of follicle-stimulating hormone.
* Women without an intact uterus AND
* ≥ 55 years of age, OR
* \< 55 years of age and postmenopausal levels of follicle-stimulating hormone
* Both ovaries removed (prior to the diagnosis of breast cancer).
4. Tumour measurable by clinical examination, mammography and ultrasound
5. Adequate bone marrow function as shown by:
* WBC ≥ 3.5 x 10\^9/L
* ANC ≥ 1.5 x 10\^9/L
* Platelets ≥ LLN
* Hb \> 10 g/dL
Exclusion Criteria
2. Patients with bilateral breast tumours.
3. Patients who are eligible for breast conserving surgery.
4. Evidence of inflammatory breast cancer or distant metastasis.
5. Simultaneous anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers, endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. NOTE: Bisphosphonate therapy for osteoporosis is NOT excluded, and can be continued. Patients who have received hormone replacement therapy will NOT be excluded if it is discontinued at least 2 weeks before starting the study.
The following additional treatments are NOT allowed during the treatment phase of the study:
* Any other anti-cancer therapy
* Hormone replacement therapy.
* Estrogen cream (including any intra-vaginal preparation).
* Steroids other than creams or inhalers.
* Megestrol acetate for the treatment of hot flushes.
* Radiation therapy.
18 Years
80 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmeceuticals
Locations
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Novartis Investigative Site
Bournemouth, , United Kingdom
Novartis Investigative Site
Brighton, , United Kingdom
Novartis Investigative Site
Bristol, , United Kingdom
Novartis Investigative Site
Crewe, , United Kingdom
Novartis Investigative Site
Dundee, , United Kingdom
Novartis Investigative Site
East Sussex, , United Kingdom
Novartis Investigative Site
Epping, , United Kingdom
Novartis Investigative Site
Farnworth, , United Kingdom
Novartis Investigative Site
Gateshead, , United Kingdom
Novartis Investigative Site
Glasgow, , United Kingdom
Novartis Investigative Site
Hants, , United Kingdom
Novartis Investigative Site
Leicester, , United Kingdom
Novartis Investigative Site
Liverpool, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Luton, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Novartis Investigative Site
Newcastle, , United Kingdom
Novartis Investigative Site
Poole, , United Kingdom
Novartis Investigative Site
Saint Leonards-on-Sea, , United Kingdom
Novartis Investigative Site
West Smithfield, , United Kingdom
Countries
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References
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Carpenter R, Doughty JC, Cordiner C, Moss N, Gandhi A, Wilson C, Andrews C, Ellis G, Gui G, Skene AI. Optimum duration of neoadjuvant letrozole to permit breast conserving surgery. Breast Cancer Res Treat. 2014 Apr;144(3):569-76. doi: 10.1007/s10549-014-2835-8. Epub 2014 Feb 23.
Other Identifiers
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CFEM345EGB07
Identifier Type: -
Identifier Source: org_study_id
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