Clinical trial · Interventional
Zoledronic Acid in the Treatment of Breast Cancer With Minimal Residual Disease in the Bone Marrow
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid + Calcium/Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- interventionNames
- Drug: Zoledronic acid + Calcium/Vitamin D
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- interventionNames
- Drug: Zoledronic acid + Calcium/Vitamin D
Primary outcomes (1)
- measure
- Reduction of detected tumor cells in bone marrow
- timeFrame
- 12 months
Secondary outcomes (5)
- measure
- Tumor cell detection in bone marrow in comparison to the time point of primary surgery (Baseline).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDAdams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2. PMID 38979716
- DERIVEDBanys 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. PMID 24128322