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

Primary Breast Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00172068
• Other study ID #: CZOL446GDE05
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: December 21, 2009
• Start date: January 2002

Study information

• Verified date: December 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm, Residual
• Primary Breast Cancer

Intervention

Drug:
• Zoledronic acid + Calcium/Vitamin D

Locations

Country	Name	City	State
Germany	Novartis Invstigative Site	Bielefeld
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of detected tumor cells in bone marrow		12 months	No
Secondary	Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).		24 months	No
Secondary	Bone metastases-free survival		24 months	No
Secondary	Disease-free survival		24 months	No
Secondary	Bone mineral density		at 12 and 24 months	No
Secondary	Number and localization of bone metastases		24 months	No