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

Phase 2

Terminated

• Conditions: Primary Breast Cancer
• Interventions: Drug: Zoledronic acid + Calcium/Vitamin D

• Registration Number: NCT00172068
• Lead Sponsor: Novartis Pharmaceuticals

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 available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-11
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-21
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Zoledronic acid + Calcium/Vitamin D	-
Treatment Group	Zoledronic acid + Calcium/Vitamin D	-

Primary Outcome Measures

Name	Time	Method
Reduction of detected tumor cells in bone marrow	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Novartis Invstigative Site; 🇩🇪 Bielefeld, Germany

Novartis Investigative Site; 🇩🇪 Tuebingen, Germany