UMIN-CTR Clinical Trial

Basic information
Public title	Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Acronym	Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Scientific Title	Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Scientific Title:Acronym	Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To investigate the possibility of de-escalation therapy omitting postoperative radiation therapy after conservative surgery in patients with primary invasive breast cancer who have no lymph node metastasis and lymph-vascular invasion and low risk of local recurrence
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of invasive cancer in the preserved breast (limited to the first recurrence)
Key secondary outcomes	1. Incidence of cancer in the preserved breast 2. Incidence of true recurrence (TR) and new primary lesion (NP) 3. Recurrence-free survival rate 4. Overall survival rate 5. Search for risk factors for ipsilateral breast cancer (Age, ER status, PgR status, HER2 status, tumor diameter, Nuclear grade) 6. Incidence of contralateral breast cancer 7. Incidence of distant metastases 8. Incidence of local recurrence rate 9. Incidence of symptomatic pneumonitis 10. Incidence rate of symptomatic cardiac dysfunction 11. Incidence and degree of skin disorders

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Omission of radiation therapy after breast-conserving surgery
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) Histologically diagnosed invasive breast cancer (irrespective of histological type). 2) TNM classification: pT1-T2pN0 3) Partial mastectomy is performed by vertical resection in which lateral stump can be diagnosed. 4) There is no residual cancer on the skin or pectoralis major muscle. 5) Partial mastectomy specimens are pathologically examined at intervals of 5 mm, and an experienced breast pathologist has concluded complete resection (the distance from the lateral stump to the cancer cells is longer than 5 mm). 6) Histologically no lymph-vascular invasion detected. 7) Age at registration is 20 years or older 8) Performance status (ECOG) is 0 or 1. 9) Main organ functions are maintained. 10) Patients have given their consent to participate in the study through the documents.
Key exclusion criteria	1) Bilateral breast cancer cases 2) Double cancer cases (within 5 years after completion of treatment) 3) Cases of additional resection during surgery 4) Cases of excisional biopsy 5) Patients who have not undergone standard surgery on lymph nodes 6) BRCA mutation positive cases 7)When the doctor in charge determines that it is inappropriate
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Ueno
Organization	Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Department of Breast Surgical Oncology, Breast Oncology Center
Zip code	1358550
Address	3-8-31, Ariake, Koto-ku, Tokyo
TEL	0335200111
Email	takayuki.ueno@jfcr.or.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Ueno
Organization	Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Department of Breast Surgical Oncology, Breast Oncology Center
Zip code	1358550
Address	3-8-31, Ariake, Koto-ku, Tokyo
TEL	0335200111
Homepage URL
Email	takayuki.ueno@jfcr.or.jp

Sponsor
Institute	Department of Breast Surgical Oncology, Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization	None
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	Medical Research Ethics Review Committee, Japanese Foundation for Cancer Research
Address	3-8-31, Ariake, Koto-ku, Tokyo
Tel	0335200111
Email	med.shinsa@jfcr.or.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	がん研究会有明病院　乳腺センター　乳腺外科（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 01 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	Enrolling by invitation
Date of protocol fixation	2020 Year 04 Month 15 Day
Date of IRB	2020 Year 04 Month 15 Day
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2026 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 27 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045917

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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