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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026976
Receipt No. R000030933
Scientific Title Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT) for breast cancer patients after neoadjuvant chemotherapy
Date of disclosure of the study information 2017/04/13
Last modified on 2019/10/15

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Basic information
Public title Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT) for breast cancer patients after neoadjuvant chemotherapy
Acronym COMBAT-NEO
Scientific Title Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT) for breast cancer patients after neoadjuvant chemotherapy
Scientific Title:Acronym COMBAT-NEO
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety and efficacy of accelerated partial breast irradiation using multicatheter brachytherapy followed by breast-conserving surgery will be evaluated in patients with breast cancer after neoadjuvant chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Acute toxicities
Key secondary outcomes

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
Maneuver
Interventions/Control_1 Breast-conserving therapy using multicatheter brachytherapy APBI(4Gyx8fr)
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
40 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Histologically confirmed breast cancer
2. Stage I~III
3. Maximum diameter is 3cm or less after chemotherapy
4. Candidate of breast-conserving surgery
5. Female
6. Age is 40 years or older
7. Written informed consent form
Key exclusion criteria 1. Mastectomy
2. Recurrent disease
3. Paget disease
4. Connective tissue disease
5. Pregnancy
6. Inappropriate cases judged by investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuhiko
Middle name
Last name Sato
Organization Tokyo-West Tokushukai Hospital
Division name Department of Breast Oncology
Zip code 196-0003
Address 3-1-1 Matsubara, Akishima, Tokyo 196-0003 JAPAN
TEL +81-570-064-660
Email kaz.sato@tokushukai.jp

Public contact
Name of contact person
1st name Hiromi
Middle name
Last name Fuchikami
Organization Tokyo-West Tokushukai Hospital
Division name Department of Breast Oncology
Zip code 196-0003
Address 3-1-1 Matsubara, Akishima, Tokyo 196-0003 JAPAN
TEL +81-570-064-660
Homepage URL
Email sswkw540@gmail.com

Sponsor
Institute Tokyo-West Tokushukai Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mirai Iryou Research Center inc.
Address 1 Chome-8-7 Kojimachi, Chiyoda City, Tokyo 102-0083
Tel +81-3-3263-4801
Email cho@mirai-iryo.com

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
2017 Year 04 Month 13 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
2017 Year 04 Month 12 Day
Date of IRB
2017 Year 04 Month 06 Day
Anticipated trial start date
2017 Year 04 Month 14 Day
Last follow-up date
2027 Year 04 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 13 Day
Last modified on
2019 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030933

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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