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Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330317
Recruitment Status : Completed
First Posted : May 26, 2006
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: letrozole Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : November 16, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arms and Interventions
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Arm Intervention/treatment
Experimental: Letrozole Drug: letrozole
2.5mg letrozole once-daily
Other Name: Femara, FEM345


Outcome Measures
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Primary Outcome Measures :
  1. Optimum length of treatment with letrozole (2.5 mg daily) preoperatively, on tumour measured by clinical examination and breast ultrasound [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Reduction in tumour volume every 2 months throughout the study [ Time Frame: 12 months ]
  2. Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria [ Time Frame: 12 months ]
  3. Long term (5-year) local recurrence rate [ Time Frame: 5 years ]
  4. Safety and tolerability of the treatment prior to surgery [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330317


Locations
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United Kingdom
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
St. Leonards on Sea, United Kingdom
Novartis Investigative Site
West Smithfield, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
More Information
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Publications of Results:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00330317    
Other Study ID Numbers: CFEM345EGB07
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Letrozole
Breast Conserving Surgery
NeoAdjuvant
Early Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs