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

NCT ID: NCT00247650

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zoledronic Acid; Letrozole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Novartis

Locations

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Novartis Investigative Site

Edmonton, Alberta, Canada

Site Status

Novartis Investigative Site

Vancouver, British Columbia, Canada

Site Status

Novartis Investigative Site

Victoria, British Columbia, Canada

Site Status

Novartis Investigative Site

London, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Windsor, Ontario, Canada

Site Status

Novartis Investigative Site

Granby, Quebec, Canada

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Québec, Quebec, Canada

Site Status

Novartis Investigative Site

Victoriaville, Quebec, Canada

Site Status

Countries

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Canada

References

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Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.

Reference Type DERIVED
PMID: 38979716 (View on PubMed)

Other Identifiers

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CZOL446GCA08

Identifier Type: -

Identifier Source: org_study_id

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