UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004460 |
|---|---|
| Receipt number | R000005344 |
| Scientific Title | Neoadjuvant chemotherapy and radiotherapy for operable breast cancer |
| Date of disclosure of the study information | 2010/10/27 |
| Last modified on | 2017/05/08 10:51:52 |
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Basic information
Public title
Neoadjuvant chemotherapy and radiotherapy for operable breast cancer
Acronym
Neo CR
Scientific Title
Neoadjuvant chemotherapy and radiotherapy for operable breast cancer
Scientific Title:Acronym
Neo CR
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of anthracycline, paclitaxel and radiotherapy in the neoadjuvant setting for operable breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
pathological complete response rate
Key secondary outcomes
clinical response rate
disease free survival
rate of breast-conserving surgery
adverse events
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 | Maneuver |
Interventions/Control_1
neoadjuvant chemotherapy and radiotherapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) biopsy-proven invasive breast cancer
2) TNM classification: T2-T4, N0-2, M0
3) HER2-negative tumor
4) PS (ECOG): 0 or 1
5) Normal bone marrow, liver and renal function
6) Patients who have never received any treatment for breast cancer
7) Written informed consent is obtained
Key exclusion criteria
1) past history of any invasive malignancy within the previous 5 years
2) past history of breast cancer or synchronous bilateral breast cancer
3) past history of radiotherapy for ipsilateral breast
4) Suspicious of allergy for radiotherapy
5) Suspicious of allergy for paclitaxel, 5FU, epirubicin or cyclophosphamide
7) Patients during uncontrollable diabetes or psychologic disorder
8) Patients who have grade3-4 neuropathy
9) Pregnant or breast-feeding
10) Any reason the physician believes that the patient is not appropriate to participate in the study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ishitobi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
0669721181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
TEL
Homepage URL
isitobi-ma@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 27 | 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
| 2010 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 26 | 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
| 2010 | Year | 10 | Month | 27 | Day |
Last modified on
| 2017 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005344
