UMIN-CTR Clinical Trial

Basic information
Public title	Intensive vs. standard post-operative surveillance in high risk breast cancer patients (JCOG1204, INSPIRE)
Acronym	Intensive vs. standard post-operative surveillance in high risk breast cancer patients (JCOG1204, INSPIRE)
Scientific Title	Intensive vs. standard post-operative surveillance in high risk breast cancer patients (JCOG1204, INSPIRE)
Scientific Title:Acronym	Intensive vs. standard post-operative surveillance in high risk breast cancer patients (JCOG1204, INSPIRE)
Region	Japan

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

Objectives
Narrative objectives1	To confirm the superiority of intensive follow-up to standard follow-up in terms of overall survival in high-risk breast cancer patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Disease-free survival, Relapse-free survival, Distant metastasis-free survival, Overall survival of intrinsic subtypes, Actual number of implemented examination, Compliance of prespecified examination, Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	A: Standard follow-up Mammography and tumor marker (CEA, CA15-3) once a year, plus routine physical examination (every 3 months for the first 3 years, every 6 months for the next 2 years, and every year afterwards)
Interventions/Control_2	B: Intensive follow-up Mammography and routine physical examination (same schedule as the arm A); tumor marker (CEA, CA15-3) every 3 months for the first 3 years, every 6 months for the next 2 year; Chest CT, abdomen CT, bone scintigraphy, brain MRI/CT twice a year for the first 3 years and every year for the next 2 years.
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	70 years-old >=
Gender	Female
Key inclusion criteria	1. Histologically proven breast cancer confirmed by biopsy or pathological examination in the resected tumor. 2. No macroscopic or microscopic residual tumor by total or partial mastectomy performed within 84 days before the registration. 3. The status of axillary lymph node confirmed by axillary resection or sentinel lymph node biopsy fulfills any of the followings: i) Having 4 or more axillary nodal metastasis in high estrogen receptor positive patients without preoperative chemotherapy ii) Having 1 or more axillary nodal metastasis in low estrogen receptor or negative patients without preoperative chemothepapy iii) Having 1 or more axillary nodal metastasis in high estrogen receptor positive patients with preoperative chemotherapy iv) Histologically proven residual invasive cancer in the breast or axilla in low estrogen receptor or negative patients with preoperative chemotherapy * High estrogen receptor positive is defined as high percentage of estrogen receptor staining (10% or more) in immunohistochemical staining, or proportion score of 3 or more in Allred score. * Low estrogen receptor positive is defined as low percentage of estrogen receptor staining (1% to less than 10%) in immunohistochemical staining, or proportion score of 2 or more in Allred score, or proportion score of 1 and intensity score of 2 to 3 in Allred score. 4. No distant metastasis found within 168 days before the registration. 5. ER status and HER2 status has already been examined. 6. No bilateral breast cancer. 7. Able to receive the examinations in each arm specified in the protocol. 8. Women aged 20 to 70 years old. 9. ECOG performance status (PS) of 0 or 1. 10. Witten informed consent.
Key exclusion criteria	1. Simultaneous or metachronous (within 5 years) double cancers. 2. Infectious disease to be treated. 3. Psychiatric diseases. 4. Systemic and continuous steroids medication (>= 5 mg/day of prednisolone). 5. Diabetes mellitus uncontrollable 6. Uncontrollable hypertension. 7. Comorbid unstable angina pectoris or history of myocardial infarction within 6 months. 8. Interstitial pneumonitis, pulmonary fibrosis or severe pulmonary emphysema
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroji Iwata
Organization	Aichi Cancer Center Hospital
Division name	Department of Breast Oncology
Zip code
Address	1-1, Kanokoden, Chikusa-ku, Nagoya 464-8661, Japan
TEL	052-762-6111ext.3112
Email	hiwata@aichi-cc.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Hojo
Organization	JCOG1204 Coordinating Office
Division name	Department of Breast Surgery, National Cancer Center Hospital East
Zip code
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL	04-7133-1111
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
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

国立病院機構北海道がんセンター（北海道） 岩手医科大学（岩手県） 筑波大学医学医療系（茨城県） 自治医科大学（栃木県） 群馬県立がんセンター（群馬県） 埼玉県立がんセンター（埼玉県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 国立がん研究センター中央病院（東京都） がん・感染症センター都立駒込病院（東京都） 国立病院機構東京医療センター（東京都） 慶應義塾大学病院（東京都） がん研究会有明病院（東京都） 虎の門病院（東京都） 聖路加国際病院（東京都） 東海大学医学部（神奈川県） 聖マリアンナ医科大学（神奈川県） 北里大学医学部（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 静岡県立総合病院（静岡県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 国立病院機構名古屋医療センター（愛知県） 名古屋市立大学病院（愛知県） 近畿大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 国立病院機構大阪医療センター（大阪府） 岡山大学病院（岡山県） 国立病院機構呉医療センター・中国がんセンター（広島県） 広島大学病院（広島県） 広島市立広島市民病院（広島県） 国立病院機構福山医療センター（広島県） 広島市立安佐市民病院（広島県） 国立病院機構四国がんセンター（愛媛県） 国立病院機構九州がんセンター（福岡県） 北九州市立医療センター（福岡県） 国立病院機構長崎医療センター（長崎県） 博愛会相良病院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 28 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	No longer recruiting
Date of protocol fixation	2013 Year 09 Month 27 Day
Date of IRB	2013 Year 10 Month 31 Day
Anticipated trial start date	2013 Year 11 Month 28 Day
Last follow-up date	2027 Year 11 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 28 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014255