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

February 3, 2017 updated by: Novartis Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • 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
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letrozole
Drug: letrozole
2.5mg letrozole once-daily
Other Names:
  • Femara, FEM345

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

November 16, 2010

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (Estimate)

May 26, 2006

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345EGB07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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