UMIN-CTR Clinical Trial

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

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

11

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

11

Month

28

Day

Last modified on

2021

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014255