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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00172068
• Collaborator: (none)
• Enrollment: 96
• Locations: 4
• Arms: 2
• Patients Per Site: 24

Study Details

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: Jan 1, 2002
• Actual Primary Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group	Drug: Zoledronic acid + Calcium/Vitamin D
Active Comparator: Control Group	Drug: Zoledronic acid + Calcium/Vitamin D

Outcome Measures

Primary Outcome Measures

1. Reduction of detected tumor cells in bone marrow [12 months]

Secondary Outcome Measures

1. Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline). [24 months]

2. Bone metastases-free survival [24 months]

3. Disease-free survival [24 months]

4. Bone mineral density [at 12 and 24 months]

5. Number and localization of bone metastases [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Invstigative Site	Bielefeld		Germany
2	Novartis Investigative Site	Hannover		Germany
3	Novartis Investigative Site	München		Germany
4	Novartis Investigative Site	Tuebingen		Germany

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmeceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00172068
• Other Study ID Numbers: CZOL446GDE05
• First Posted: Sep 15, 2005
• Last Update Posted: Dec 23, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Primary breast cancer; Bone metastases; Minimal residual disease; Bisphosphonates
• Additional relevant MeSH terms: Breast Neoplasms; Vitamin D; Zoledronic Acid; Calcium

Study Results

No Results Posted as of Dec 23, 2009