UMIN-CTR Clinical Trial

Public title

A randomized controlled trial comparing primary tumor resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (JCOG1017, PRIM-BC).

Acronym

A randomized controlled trial comparing primary tumor resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (JCOG1017, PRIM-BC).

Scientific Title

A randomized controlled trial comparing primary tumor resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (JCOG1017, PRIM-BC).

Scientific Title:Acronym

A randomized controlled trial comparing primary tumor resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (JCOG1017, PRIM-BC).

Region

Japan

Condition

Metastatic breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To demonstrate the superiority in overall survival of primary tumor resection plus systemic therapy over systemic therapy alone in patients with stage IV breast cancer who are not refractory to primarty systemic therapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Overall survival

Key secondary outcomes

Proportion of patients without progression in metastatic sites, yearly local recurrence-free survival, incidence of local ulcer/local bleeding, yearly primary tumor resection-free survival, adverse events of chemotherapy, operative morbidity, serious 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

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A: Systemic therapy alone

Interventions/Control_2

B: Primary tumor resection plus systemic therapy

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

80

years-old

>=

Gender

Female

Key inclusion criteria

First registration
1. Histologically proven breast cancer confirmed by biopsy from the tumor.
2. Presense/absence of overexpression of estrogen receptor (ER) and HER2 was examined by IHC or FISH or DISH analyses.
3. Neither bilateral breast cancer nor invasion to contralateral breast.
4. At least one measurable lesion other than the breast tumor and ipsilateral axillary lymph nodes was detected by CT or MRI before primary registration.
5. No brain metastasis.
6. Women aged 20 to 80 years old.
7. ECOG performance status (PS) of 0 or 1. PS of 2 caused by the symptom from bone metastasis is also eligible.
8. No prior surgery, chemotherapy or radiotherapy for any other malignancies within 5 years.
9. No history of invasive breast cancer. Non-invasive breast cancer resected completely by partial mastectomy is eligible.
10. Neither prior chemotherapy for breast cancer nor prior radiotherapy for ipsilateral breast (radiotherapy for bone metastasis within 30Gy and 10 times before registration is allowed).
11. Sufficient organ functions.
12. Witten informed consent.

Second registration (after primary chemotherapy)
1. Primary chemotherapy was performed after the first registration and protocol treatment is not discontinued.
2. Objective response of primary chemotherapy was neither PD nor NE.
3. Within 28 days from the date of response evaluation.
4. Sufficient organ functions.
5. Complete resection is expected to be possible by total or patial mastectomy without resection of adjacent organs and/or wide skin transplant.
6. No active bleeding from breast tumor which necessitates blood transfusion within 28 days before second regstration.

Key exclusion criteria

First registration (no exclusion criteria at second registration)
1. Simultaneous or metachronous (within 5 years) double cancers.
2. Infectius disease to be treated.
3. Body temperature of 38C or higher.
4. Women during pregnancy or breast-feeding.
5. Psychiatric diseases.
6. Systemic and continuous steroids medication.
7. Comorbid unstable angina pectoris or history of myocardial infarction within 6 months.
8. Uncotrollable hypertension.
9. Diabetes mellitus uncontrollable or treated by continuous insulin administration .

Target sample size

600

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

052-762-6111

Email

hiwata@aichi-cc.jp

Name of contact person

1st name
Middle name
Last name	Tadahiko Shien

Organization

JCOG1017 Coordinating Office

Division name

Department of Breast and Thyroid Surgery, Okayama University Hospital

Zip code

Address

2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan

TEL

086-235-7265

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

2011

Year

05

Month

11

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

2011

Year

03

Month

02

Day

Date of IRB

2011

Year

04

Month

26

Day

Anticipated trial start date

2011

Year

05

Month

11

Day

Last follow-up date

2025

Year

05

Month

11

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

05

Month

11

Day

Last modified on

2021

Year

01

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006333