UMIN-CTR Clinical Trial

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

Objectives
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

Assessment
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.

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	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

Eligibility
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

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	052-762-6111
Email	hiwata@aichi-cc.jp

Public contact
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

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	2011 Year 05 Month 11 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	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
Other related information

Management information
Registered date	2011 Year 05 Month 11 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006333