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Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow (MRD-1)

Primary Purpose

Primary Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Zoledronic acid + Calcium/Vitamin D
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Breast Cancer focused on measuring Primary breast cancer, Bone metastases, Minimal residual disease, Bisphosphonates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Invstigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Reduction of detected tumor cells in bone marrow

Secondary Outcome Measures

Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).
Bone metastases-free survival
Disease-free survival
Bone mineral density
Number and localization of bone metastases

Full Information

First Posted
September 13, 2005
Last Updated
December 21, 2009
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00172068
Brief Title
Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow
Acronym
MRD-1
Official Title
Efficacy and Tolerability of Intravenous Zometa® (Zoledronic Acid) 4 mg in Primary Breast Cancer Patients With Disseminated Tumor Cells in Bone Marrow. A Prospective, Randomized, Parallel Group, Open-label, Clinical Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Study Start Date
January 2002 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Breast Cancer
Keywords
Primary breast cancer, Bone metastases, Minimal residual disease, Bisphosphonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid + Calcium/Vitamin D
Primary Outcome Measure Information:
Title
Reduction of detected tumor cells in bone marrow
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).
Time Frame
24 months
Title
Bone metastases-free survival
Time Frame
24 months
Title
Disease-free survival
Time Frame
24 months
Title
Bone mineral density
Time Frame
at 12 and 24 months
Title
Number and localization of bone metastases
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmeceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Invstigative Site
City
Bielefeld
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
Country
Germany
Facility Name
Novartis Investigative Site
City
München
Country
Germany
Facility Name
Novartis Investigative Site
City
Tuebingen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24128322
Citation
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.
Results Reference
derived

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

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