Status:
TERMINATED
Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Primary Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00172068
Start Date
January 1 2002
Last Update
December 23 2009
Active Locations (4)
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1
Novartis Invstigative Site
Bielefeld, Germany
2
Novartis Investigative Site
Hanover, Germany
3
Novartis Investigative Site
München, Germany
4
Novartis Investigative Site
Tübingen, Germany