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Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer
This study is currently recruiting participants.
Verified by Novartis, May 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00330317
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: letrozole
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Letrozole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Neoadjuvant 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 Letrozole (2.5 mg Daily) on Tumour Regression to Permit Breast Conserving Surgery

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound

Secondary Outcome Measures:
  • Reduction in tumour volume every 2 months throughout the study
  • Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria
  • Long term (5-year) local recurrence rate
  • Safety and tolerability of the treatment prior to surgery

Estimated Enrollment: 300
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Postmenopausal women able to comply with the protocol requirements with confirmed primary invasive breast cancer whose tumours are estrogen-and/or progesterone-receptor positive
  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:

  1. Multifocal disease (cancer that starts in several different sites)
  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.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330317

Contacts
Contact: Sunjeet Sawhney 01276 698 8760

Locations
United Kingdom
Recruiting
West Smithfield, United Kingdom
Recruiting
Liverpool, United Kingdom
Recruiting
Manchester, United Kingdom
Recruiting
Bristol, United Kingdom
Recruiting
Bournemouth, United Kingdom
Recruiting
Dundee, United Kingdom
Recruiting
Glasgow, United Kingdom
Recruiting
Hants, United Kingdom
Recruiting
London, United Kingdom
Recruiting
Luton, United Kingdom
Recruiting
Newcastle, United Kingdom
Recruiting
East Sussex, United Kingdom
Recruiting
Leicester, United Kingdom
Recruiting
Brighton, United Kingdom
Recruiting
Crewe, United Kingdom
Recruiting
Gateshead, United Kingdom
Recruiting
Farnworth, United Kingdom
Recruiting
Epping, United Kingdom
Recruiting
St. Leonards on Sea, United Kingdom
Recruiting
Poole, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Study ID Numbers: CFEM345EGB07
Study First Received: May 24, 2006
Last Updated: May 1, 2008
ClinicalTrials.gov Identifier: NCT00330317  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Letrozole
Breast Conserving Surgery
NeoAdjuvant
Early Breast Cancer

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009