Clinical trial · Interventional
Evaluation of Chemotherapy Prior to Surgery With or Without Zometa for Women With Locally Advanced Breast Cancer
Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer
NCT00242203CI-TRIAL-00011753completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is designed to evaluate the impact of Zometa on clearance of bone marrow micrometastases; the protective effect on chemotherapy-induced loss of bone mineral density; and quality of life in women undergoing treatment for locally advanced breast cancer.
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 |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| External beam radiation | Radiation | — | UNRESOLVED |
| Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection | Procedure | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
| Zometa | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zometa
- description
- Zometa 4 mg IV every 3 weeks for a total of 17 doses. The first treatment will be given at the time of the first chemotherapy treatment and will continue for approximately 1 year. Neoadjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 4 cycles prior to surgery * Docetaxel 75 mg/m2 IV every 21 days for 4 cycles prior to surgery Surgery - modified radical mastectomy or breast conserving surgery with axillary lymph node dissection Adjuvant therapy * Epirubicin 75 mg/m2 IV every 21 days for 2 cycles * Docetaxel 75 mg/m2 IV every 21 days for 2 cycles * All patients who are found to be Her-2 overexpressing by 3+ by ICH for FSH will receive trastuzumab 6 mg/kg IV every 3 weeks for 1 year post surgery Radiation therapy - 50-60 Gy in 1.8-2.0 Gy daily fractions to the breast or chest wall. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks
- interventionNames
- Drug: Zometa
- Drug: Epirubicin
- Drug: Docetaxel
- Drug: Trastuzumab
- Radiation: External beam radiation
- Procedure: Modified radical mastectomy or breast conserving surgery with axillary lymph node dissection
- type
- ACTIVE_COMPARATOR
- label
- No Zometa
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed primary invasive ductal or invasive lobular breast adenocarcinoma * Tumor classified as clinically large T2 (2-5 cm), T3, T4 or any T with N1, N2 * Prior malignancies: limited to curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated and now \> 5 years disease free * \>= 18 years of age * Normal left ventricular function by echocardiogram or radioventriculogram * Karnofsky Performance \>= 70 Exclusion Criteria: * No evidence of distant metastasis present by CT, Bone scan, or physical exam * If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions may be further clarified by additional testing such as PET or MRI * No current treatment with Zometa or other bisphosphonates * No serious functional disorders of the liver or kidneys: * Serum Creatinine \<=2 * ALT/AST/ALK Phos \<= 1.5 x upper limit of institutional normal. * Bili \<= 1.5 x upper limit of institutional normal. * Currently not pregnant
References
Publications (32)
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- BACKGROUNDGlackin CA, Murray EJ, Murray SS. Doxorubicin inhibits differentiation and enhances expression of the helix-loop-helix genes Id and mTwi in mouse osteoblastic cells. Biochem Int. 1992 Oct;28(1):67-75.