Phase II study of neoadjuvant zoledronic acid therapy for early breast cancer patients
Phase 2
Recruiting
- Conditions
- early breast cancer
- Registration Number
- JPRN-UMIN000003493
- Lead Sponsor
- Division of Medical Oncology and Breast Surgery, Cancer Institute Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) non-invasive or minimally-invasive breast cancer 2) stage IV or inflammatory breast caner 3) male breast cancer 4) Patients who have treated with endocrine therapy, chemotherapy, or radiation therapy 5) Patients with previous or concomitant active malignancy 6) Patients who have serious complication (infection, cardiac disease, lung fibrosis, interstitial pneumonitis, bleeding tendency, etc.) 7) HB hepatitis 8) Patients who have poor-controlled DM 9) Patients who have hypersensitivity to bisphosphonates 10) Patients who needs invasive dental procedures 11) Patients who is pregnant, lactating or willing to be pregnant 12) Other conditions judged as inappropriate for the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological response rate
- Secondary Outcome Measures
Name Time Method pathological complete response rate, breast conservation rate, axillar lymph node complete response rate, distant metastasis-free survival, disease-free survival, overall survival, adverse effects, changes of disseminated tumor cells, circulating tumor cells, and circulating endothelial cells