Clinical trial NCT00172068: Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Primary Breast Cancer
Keywords: Primary breast cancer
Bone metastases
Minimal residual disease
Bisphosphonates
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction of detected tumor cells in bone marrow
timeFrame: 12 months
Secondary outcomes:
measure: Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).
timeFrame: 24 months
measure: Bone metastases-free survival
timeFrame: 24 months
measure: Disease-free survival
timeFrame: 24 months
measure: Bone mineral density
timeFrame: at 12 and 24 months
measure: Number and localization of bone metastases
timeFrame: 24 months
Other outcomes:
Locations:
city: Bielefeld
country: Germany
facility: Novartis Invstigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Banys M, Solomayer EF, Gebauer G, Janni W, Krawczyk N, Lueck HJ, Becker S, Huober J, Kraemer B, Wackwitz B, Hirnle P, Wallwiener D, Fehm T. Influence of zoledronic acid on disseminated tumor cells in bone marrow and survival: results of a prospective clinical trial. BMC Cancer. 2013 Oct 15;13:480. doi: 10.1186/1471-2407-13-480.