UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masakazu Toi
Organization	Graduate School of Medicie, Kyoto University
Division name	Breast Surgery
Address	54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3660
Email

Public contact
Name of contact person	Tomoharu Sugie
Organization	Graduate School of Medicie, Kyoto University
Division name	Breast Surgery
Address	54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Breast Surgery, Graduate School of Medicine, Kyoto University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010095