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OpenTrials
Completed

NCT Number: NCT00332852

Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer.

This trial is not recruiting patients in the United States.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Albstadt, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
  • Nodal status negative or positive
  • Good Health status 0-2 (Eastern Cooperative Oncology Group)
  • Estrogen- and/or progesterone-receptor positive
  • Adequate marrow, kidney and liver function

Exclusion criteria

  • Metastatic or inflammatory breast cancer
  • Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases.
  • Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks) or planned dental or jaw surgery
  • Patients with primary overactive parathyroid
  • Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.

Treatment and study plan

letrozole

Drug

2.5 mg/day - oraly

Other names: Femara, FEM345

Primary outcomes

  1. Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging

    Time frame: after 24 months

Secondary outcomes

  1. Disease free survival (DFS)

    Time frame: every 6 months for 24 months

  2. Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months

    Time frame: Every 6 months

  3. Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation

    Time frame: every 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Important dates

Study start
2006
Primary completion
2010
First posted
Jun 2, 2006
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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