Multicenter phase II trial to assess clinical benefit of zoledronic acid with neo adjuvant endocrine treatment and the relationship between zoledronic acid use and gammadelta T cells for postmenopausal breast cancer.
- Conditions
- Postmenopausal ER positive and HER2 negative primary breast cancer
- Registration Number
- JPRN-UMIN000008701
- Lead Sponsor
- Breast Surgery, Graduate School of Medicine, Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 75
Not provided
1)Hyperparathyroidism requires for treatment, Uncontrolled diabetes mellitus, Disease requires continuous and systemic administration of steroid hormone, Dental and/or periodontal disease which requires invasive treatment after registration. 2)Synchronous double cancer, Met asynchronous double cancer diagnosed in 5 years (excluding basal cell carcinoma, carcinoma in situ, superficial bladder cancer, neoplasms cured by endoscopic surgery)3)Prior treatament with bisphosphonates 4)Patients who have received hormone replacement therapy ( If HRP is stopped more than 7 days prior to study entry, they meet registration criteria.) 5)Hypersensitivity to contrast materials for MRI 6)Use of other investigational drugs in 28 days prior to study entry 7)Patients who are judged inappropriate for the clinical trial by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response
- Secondary Outcome Measures
Name Time Method Change of tumor volume on MRI volumetry. Tumor response assessed by caliper and US. Induction and activation of gammadelta T cells. PEPI socore and Ki67 after treatment