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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002655
Receipt No. 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

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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
Email

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
Email sosumi@shikoku-cc.go.jp

Sponsor
Institute Study Group for Development of Optimal Local Therapy for Breast Cancer based on the Risk of Recurrence
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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