UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003493 |
|---|---|
| Receipt number | R000004232 |
| Scientific Title | Phase II study of neoadjuvant zoledronic acid therapy for early breast cancer patients |
| Date of disclosure of the study information | 2010/04/15 |
| Last modified on | 2011/10/15 09:09:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of neoadjuvant zoledronic acid therapy for early breast cancer patients
Acronym
Phase II study of neoadjuvant zoledronic acid therapy
Scientific Title
Phase II study of neoadjuvant zoledronic acid therapy for early breast cancer patients
Scientific Title:Acronym
Phase II study of neoadjuvant zoledronic acid therapy
Region
| Japan |
Condition
Condition
early breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of zoledronic acid in the neoadjuvant chemotherapy in early breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological response rate
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Neoadjuvant chemotherapy: CEF (EpiADR 100mg/m2 D1, CPA 500mg/m2 D1, 5FU 500mg/m2 D1 per 3 weeks) 4 cycles, then weekly paclitaxel 80mg/m2 for 12 weeks.
zoledronic acid: 4mg + saline 100ml div for 15 minutes, per 3-4 weeks, 6 cycles
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) ECOG Performance status of 0 to 2
2) diagnosed as breast cancer with biopsy
3) T 3cm or more, or lymph-node positive stage IIA-Stage IIIB, HER2-negative primary breast cancer
4) Adequate organ function such as
(1) WBC: 3000 /cmm or more, and WBC< 12, 000 /cmm
(2) Hb: 9.0 g/dl or more
(3) Platelet : 100000 /cmm or more
(4) GOT/GPT: less than 3x upper normal limit
(5) T. Bil :1.5 mg/dl or less
(6) Cr: 1.5 mg/dl or less
(7) no cardiac dysfunction
(8) EF: 50% or more
5) A written informed consent is obtained
Key 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
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunji Takahashi |
Organization
Cancer Institute Hospital
Division name
Division of Medical Oncology
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
03-3570-0488
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Takahashi |
Organization
Cancer Institute Hospital
Division name
Division of Medical Oncology
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
03-3570-0488
Homepage URL
stakahas@jfcr.or.jp
Sponsor or person
Institute
Division of Medical Oncology and Breast Surgery, Cancer Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
癌研有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 15 | Day |
Last modified on
| 2011 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004232
