UMIN-CTR Clinical Trial

Basic information
Public title	A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer
Acronym	Breast Cancer II
Scientific Title	A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer
Scientific Title:Acronym	Breast Cancer II
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and efficacy of the treatment for breast cancer with carbon-ion radiotherapy instead of tumor resection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse reaction of normal tissue within 90 days after starting of the treatment.
Key secondary outcomes	1. Adverse reaction of normal tissue in late phase 2. Local effect (CR rate) 3. Local control rate with recommended dose 4. Breast cosmetic outcomes 5. Progression-free survival period 6. Overall survival period

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	Device,equipment Maneuver
Interventions/Control_1	Carbon-ion radiotherapy for breast tumor (no tumor resection). Adjuvant therapy is performed based on the guidelines for breast cancer.
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	Not applicable
Gender	Female
Key inclusion criteria	1. Pathologically proven invasive ductal carcinoma or ductal carcinoma in situ. 2. Tumor size <=20 mm on MRI. 3. No massive LVSI or EIC. 4. No lymphenode metastasis (>2 mm). Sentinel lymph node biopsy is performed prior this study. 5. No distant metastasis. 6. Performance status (ECOG) of 0 to 2. 7. 20 years old or older. 8. A life expectancy of at least 6 months. 9. Written informed consent.
Key exclusion criteria	1. Severe complication (e.g. uncontroled lung disease, heart disease, infection, or psychiatric disease). 2. Previous treatment history including surgery, chemotherapy, endocrine therapy, molecular-targeted agents for breast cancer in same side. 3. Active other malignancy 4. The distanse between skin surface and tumor (including EIC) <=5 mm. 5. Previous radiation therapy for breast cancer in same side. 6. Eligible patients for "Breast cancer I". 7. Pregnancy, pregnancy potential. 8. Ptinents who are considered inappropriate by the attending physician due to medical, psychological or other factors.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kumiko Middle name Last name Karasawa
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	QSTHospital
Zip code	285-8555
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL	043-206-3306
Email	kkarasaw@twmu.ac.jp

Public contact
Name of contact person	1st name Noriyuki Middle name Last name Okonogi
Organization	National Institutes for Quantum and Radiological Sciences and Technology
Division name	QST Hospital
Zip code	263-8555
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL	043-206-3306
Homepage URL
Email	okonogi.noriyuki@qst.go.jp

Sponsor
Institute	QST Hospital, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

Funding Source
Organization	QST Hospital, National Institutes for Quantum and Radiological Sciences and Technology
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	National Institutes for Quantum and Radiological Sciences and Technology, Certified Review Board
Address	Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
Tel	043-206-3306
Email	okonogi.noriyuki@qst.go.jp

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 10 Month 10 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 10 Month 04 Day
Date of IRB	2017 Year 10 Month 04 Day
Anticipated trial start date	2017 Year 10 Month 10 Day
Last follow-up date	2031 Year 03 Month 31 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 10 Month 09 Day
Last modified on	2019 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033679