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OpenTrials
Completed

NCT Number: NCT00247650

Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy

This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are given before surgery to newly diagnosed post-menopausal women with early breast cancer

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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

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Postmenopausal women
  • Newly diagnosed with non metastatic breast cancer
  • Candidate for mastectomy or breast-conserving surgery

Exclusion criteria

  • Patients with invasive tumors
  • Patients receiving anti-cancer treatment
  • Patients who have undergone surgery

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Zoledronic Acid; Letrozole

Drug

Primary outcomes

  1. Clinical response at 24 weeks

Secondary outcomes

  1. Clinical response at 16 weeks

  2. Clinical benefit at 16 weeks

  3. Clinical benefit at 24 weeks

  4. Rate of breast conserving surgery in both arms

  5. Rate of complete pathological response

  6. Biomarkers

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Randomized Multi-Center Study Comparing Prolonged Primary Systemic Endocrine Therapy With Letrozole Alone or in Combination With Zoledronic Acid in Early Breast Cancer (NEOadjuvant Study in CANada)

Important dates

Study start
2005
Primary completion
2007
First posted
Nov 2, 2005
Registry last updated
Mar 1, 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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