Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer
Neoadjuvant Hormone Therapy for Postmenopausal Women With HR+ Primary Breast Cancer: A Multi-center Study to Determine the Optimum Length of Treatment With Letrozole on Tumour Regression to Permit Breast Conserving Surgery.
1 other identifier
interventional
300
1 country
20
Brief Summary
The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive primary breast cancer on tumour regression to permit breast conserving surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Feb 2006
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 24, 2006
CompletedFirst Posted
Study publicly available on registry
May 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2010
CompletedFebruary 7, 2017
February 1, 2017
4.1 years
May 24, 2006
February 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound
12 months
Secondary Outcomes (4)
Reduction in tumour volume every 2 months throughout the study
12 months
Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria
12 months
Long term (5-year) local recurrence rate
5 years
Safety and tolerability of the treatment prior to surgery
5 years
Study Arms (1)
Letrozole
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive
- 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.
- 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).
- Tumour measurable by clinical examination, mammography and ultrasound
- Adequate bone marrow function as shown by:
- WBC ≥ 3.5 x 10\^9/L
- ANC ≥ 1.5 x 10\^9/L
- +2 more criteria
You may not qualify if:
- Multifocal disease (cancer that starts in several different sites)
- Patients with bilateral breast tumours.
- Patients who are eligible for breast conserving surgery.
- Evidence of inflammatory breast cancer or distant metastasis.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
Related Publications (1)
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.
PMID: 24562823RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmeceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2006
First Posted
May 26, 2006
Study Start
February 1, 2006
Primary Completion
March 1, 2010
Study Completion
November 16, 2010
Last Updated
February 7, 2017
Record last verified: 2017-02