UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008701 |
|---|---|
| Receipt number | R000010095 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2016/07/27 17:53:48 |
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Basic information
Public title
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.
Acronym
A phase II study whether zoledronic acid with neoadjuvant endocrine therapy is more effectvely related to gammadelta T cells.
Scientific Title
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.
Scientific Title:Acronym
A phase II study whether zoledronic acid with neoadjuvant endocrine therapy is more effectvely related to gammadelta T cells.
Region
| Japan |
Condition
Condition
Postmenopausal ER positive and HER2 negative primary breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A phase II study to determine whether a single dose of zoledronic acid with neoadjuvant endocrine therapy is effective and safe for ER positive, HER2 negative postmenopausal breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
letrozole plus zoledronic acid
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Primary breast cancer with T1-2 stage without any metasitasis (cT1-2cN01cM0), 2) Invasive ducaal carcinoma 3)ER positive and HER2 negative: the results of IHC test can be negative or 1+ or 2+ and FISH negative 4) Age >=60, postmenopausal 5 years, the patients who had bilateral oophorectomy. 5)No prior treatment for breast cancer, 6) Performance status 0-1, 7) Patients have a measurable lesion on enhanced MRI within 6 weeks before entru of study.
Key exclusion criteria
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
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Toi |
Organization
Graduate School of Medicie, Kyoto University
Division name
Breast Surgery
Zip code
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoharu Sugie |
Organization
Graduate School of Medicie, Kyoto University
Division name
Breast Surgery
Zip code
Address
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
Homepage URL
Sponsor or person
Institute
Breast Surgery, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 16 | Day |
Last modified on
| 2016 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010095
