Comparison Study of Letrozole Alone or Letrozole With Zol... | NCT00247650

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

NCT00247650

Sponsor

Novartis

Status

Completed

Last Update Posted

Mar 1, 2017Actual

Enrollment

190Estimated

Phase

Phase 2

Conditions

Breast Cancer

Interventions

Zoledronic Acid; Letrozole

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Not provided

First Submitted Date

Nov 1, 2005

First Submission Date that Met QC Criteria

Nov 1, 2005

First Posted Date

Nov 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic Acid; Letrozole	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical response at 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Clinical response at 16 weeks
Clinical benefit at 16 weeks
Clinical benefit at 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis	Novartis	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Edmonton	Alberta		Canada
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38979716	Derived	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals