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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)


Phase 2
65 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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)

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response at 24 weeks

Principal Investigator

Novartis

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis

Authority:

Canada: Health Canada

Study ID:

CZOL446GCA08

NCT ID:

NCT00247650

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • neoadjuvant, postmenopausal women, breast cancer, hormonal therapy, bisphosphonate
  • Breast Neoplasms

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