UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012429
Receipt number R000014255
Scientific Title Intensive vs. standard post-operative surveillance in high risk breast cancer patients (JCOG1204, INSPIRE)
Date of disclosure of the study information 2013/11/28
Last modified on 2021/01/05 16:24:04

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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 or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name



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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name