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

This study has been terminated.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00172068
First received: September 13, 2005
Last updated: December 21, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Primary Breast Cancer
Drug: Zoledronic acid + Calcium/Vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction of detected tumor cells in bone marrow [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Bone metastases-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Bone mineral density [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
  • Number and localization of bone metastases [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: January 2002
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group Drug: Zoledronic acid + Calcium/Vitamin D
Active Comparator: Control Group Drug: Zoledronic acid + Calcium/Vitamin D

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172068

Locations
Germany
Novartis Invstigative Site
Bielefeld, Germany
Novartis Investigative Site
Hannover, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Tuebingen, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00172068     History of Changes
Other Study ID Numbers: CZOL446GDE05
Study First Received: September 13, 2005
Last Updated: December 21, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Primary breast cancer
Bone metastases
Minimal residual disease
Bisphosphonates

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm, Residual
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Zoledronic acid
Vitamin D
Diphosphonates
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 24, 2014