Primary Breast Cancer
Conditions
Keywords
Primary breast cancer, Bone metastases, Minimal residual disease, Bisphosphonates
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.
Interventions
DRUGZoledronic acid + Calcium/Vitamin D
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of detected tumor cells in bone marrow | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed