Status:
COMPLETED
Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE3
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 can...
Eligibility Criteria
Inclusion
- 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
- Platelets ≥ LLN
- Hb \> 10 g/dL
Exclusion
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2010
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00330317
Start Date
February 1 2006
End Date
November 16 2010
Last Update
February 7 2017
Active Locations (20)
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1
Novartis Investigative Site
Bournemouth, United Kingdom
2
Novartis Investigative Site
Brighton, United Kingdom
3
Novartis Investigative Site
Bristol, United Kingdom
4
Novartis Investigative Site
Crewe, United Kingdom