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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Calcium; Diphosphonates; Vitamin D; Zoledronic Acid

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