Zoledronic Acid in the Treatment of Breast Cancer With Mi... | NCT00172068

Studies
Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow

NCT00172068

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Dec 23, 2009Estimated

Enrollment

96Actual

Phase

Phase 2

Conditions

Primary Breast Cancer

Interventions

Zoledronic acid + Calcium/Vitamin D

Countries

Germany

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2002

Primary Completion Date

Nov 2008Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 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

Dec 21, 2009

Last Update Posted Date

Dec 23, 2009Estimated

Description Module

Brief Summary

Metastatic bone disease is an important prognostic factor for survival which will in median be close to two years after first diagnosis of osseous metastases. This open-label study will investigate the safety and efficacy of zoledronic acid in patients with breast cancer and minimal residual disease in the bone marrow.

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

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Group	Experimental		Drug: Zoledronic acid + Calcium/Vitamin D
Control Group	Active Comparator		Drug: Zoledronic acid + Calcium/Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zoledronic acid + Calcium/Vitamin D	Drug		Control Group Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of detected tumor cells in bone marrow		12 months

Secondary Outcomes

Measure	Description	Time Frame
Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).		24 months
Bone metastases-free survival		24 months
Disease-free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients, with primary breast cancer who had undergone complete primary tumor resection and axillary lymph node dissection
Evidence of minimal residual disease (disseminated tumor cells in bone marrow)
Patients had to receive one of the following adjuvant therapy categories: chemotherapy ± hormonal therapy or hormonal therapy alone

Exclusion Criteria:

Inflammatory, metastatic or recurrent breast cancer or a history of breast cancer prior to the currently diagnosed case
Neo-adjuvant chemotherapy, neo-adjuvant hormonal therapy, or neo-adjuvant radiotherapy
Prior stem cell rescue/bone marrow transplant
History of other cancers aside from non-melanomatous skin cancer or carcinoma in situ of the uterine cervix

Additional protocol-defined inclusion / exclusion criteria may apply

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmeceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Invstigative Site		Bielefeld			Germany
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.
24128322	Derived

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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

ID	Term
D000077211	Zoledronic Acid
D002118	Calcium
D014807	Vitamin D