UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002655 |
|---|---|
| Receipt number | R000003230 |
| Scientific Title | Multicenter retrospective study for identification of risk factors of ipsilateral breast tumor recurrence in breast cancer patients treated with breast conserving therapy after neoadjuvant chemotherapy |
| Date of disclosure of the study information | 2009/10/31 |
| Last modified on | 2010/10/21 13:38:19 |
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Basic information
Public title
Multicenter retrospective study for identification of risk factors of ipsilateral breast tumor recurrence in breast cancer patients treated with breast conserving therapy after neoadjuvant chemotherapy
Acronym
Retrospective study of risk factors of in-breast recurrence in women treated with neoadjuvant chemotherapy
Scientific Title
Multicenter retrospective study for identification of risk factors of ipsilateral breast tumor recurrence in breast cancer patients treated with breast conserving therapy after neoadjuvant chemotherapy
Scientific Title:Acronym
Retrospective study of risk factors of in-breast recurrence in women treated with neoadjuvant chemotherapy
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Identification of risk factors of ipsilateral breast tumor recurrence in breast cancer patients treated with breast conserving therapy after neoadjuvant chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ipsilateral breast tumor recurrence rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. patients who started neoadjuvant chemotherapy before January 1, 2007
2. patients who had a breast cancer of 2 cm or larger by palpation
3. patients who recieved neoadjuvant chemotherapy of 3 courses or more
4. patients who experienced partial mastectomy, and axillary dissection or sentinel node biospy
5. patients who had radiotherapy at least for the breast
Key exclusion criteria
1. inflammatory breast cancer
2. non-invasive breast cancer
3. male breast cancer
4. patients with distant metastasis at diagnosis except for metastasis of supraclavicular lymph node or parasternal lymph node
5. patients treated with trastuzumab prior to surgery
6. patients treated with radiotherapy prior to surgery
7. patients treated with endocrine therapy
8. patients who received excisional biopsy prior to neoadjuvant chemotherapy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shozo Ohsumi |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Breast Oncology
Zip code
Address
Kou 160, Minami-umemoto-machi, Matsuyama
TEL
089-999-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shozo Ohsumi |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Breast Oncology
Zip code
Address
Kou 160, Minami-umemoto-machi, Matsuyama
TEL
089-999-1111
Homepage URL
sosumi@shikoku-cc.go.jp
Sponsor or person
Institute
Study Group for Development of Optimal Local Therapy for Breast Cancer based on the Risk of Recurrence
Institute
Department
Personal name
Funding Source
Organization
a Grant-in-Aid in Research of Cancer from the Ministry of Health, Labor and Welfare of Japan (21-7-4)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 10 | Month | 31 | 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
| 2009 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 06 | Month | 01 | Day |
Other
Other related information
age at diagnosis and date of birth
menopausal status
clinical T-stage (tumor diameter by palpation)
clinical N-stage
administered regimen and number of cycles of neoadjuvant chemotherapy
postoperative chemotherapy
postoperative endocrine therapy
use of adjuvant trastuzumab
type of surgery
site(s) of radiotherapy and dose
biopsy prior to neoadjuvant chemotherapy
pathological type in biopsy materials
nuclear or histological grade in biopsy materials
hormone receptor status in biopsy materials
HER2 status in biopsy materials
size of the remaining tumor by palpation
size of pathologically remaining invasive tumor
solitary or multifocal
pathological status of the surgical margins
lymph vessel or vascular involvement
nuclear or histological grade
hormone receptor status
HER2 status
pathological lymph node status
pathological response
whether remaining tumor is DCIS alone
date of the start of neoadjuvant chemotherapy
date of the definitive surgery
status of survival
status of in-breast recurrence
status of recurrence other than in-breast recurrence
Management information
Registered date
| 2009 | Year | 10 | Month | 21 | Day |
Last modified on
| 2010 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003230
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