Trial record 16 of 2620 for:    hormone therapy AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00330317
First received: May 24, 2006
Last updated: September 22, 2011
Last verified: September 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in tumour volume every 2 months throughout the study [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Response rate in line with the Response Evaluation Criteria in Solid Tumors criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Long term (5-year) local recurrence rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety and tolerability of the treatment prior to surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: February 2006
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole Drug: letrozole
2.5mg letrozole once-daily
Other Name: Femara, FEM345

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00330317     History of Changes
Other Study ID Numbers: CFEM345EGB07
Study First Received: May 24, 2006
Last Updated: September 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on August 20, 2014