NCT00172068

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

6.8 years

First QC Date

September 13, 2005

Last Update Submit

December 21, 2009

Conditions

Primary Breast Cancer

Keywords

Primary breast cancerBone metastasesMinimal residual diseaseBisphosphonates

Outcome Measures

Primary Outcomes (1)

  • Reduction of detected tumor cells in bone marrow

    12 months

Secondary Outcomes (5)

  • 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

    24 months

  • Bone mineral density

    at 12 and 24 months

  • Number and localization of bone metastases

    24 months

Study Arms (2)

Treatment Group

EXPERIMENTAL
Drug: Zoledronic acid + Calcium/Vitamin D

Control Group

ACTIVE COMPARATOR
Drug: Zoledronic acid + Calcium/Vitamin D

Interventions

Zoledronic acid + Calcium/Vitamin DDRUG
Control GroupTreatment Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Invstigative Site

Bielefeld, Germany

Location

Novartis Investigative Site

Hanover, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Tübingen, Germany

Location

Related Publications (2)

  • 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.

    PMID: 38979716DERIVED

  • Banys M, Solomayer EF, Gebauer G, Janni W, Krawczyk N, Lueck HJ, Becker S, Huober J, Kraemer B, Wackwitz B, Hirnle P, Wallwiener D, Fehm T. Influence of zoledronic acid on disseminated tumor cells in bone marrow and survival: results of a prospective clinical trial. BMC Cancer. 2013 Oct 15;13:480. doi: 10.1186/1471-2407-13-480.

    PMID: 24128322DERIVED

MeSH Terms

Conditions

Neoplasm, Residual

Interventions

Zoledronic AcidCalciumVitamin D

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmeceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

January 1, 2002

Primary Completion

November 1, 2008

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

DE(4)