UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000843 |
|---|---|
| Receipt number | R000000989 |
| Scientific Title | A phase III randomized study of capecitabine as adjuvant chemotherapy versus observation in breast cancer with pathologic residual tumors after preoperative chemotherapy(JBCRG-04) |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2021/08/27 13:43:48 |
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Basic information
Public title
A phase III randomized study of capecitabine as adjuvant chemotherapy versus observation in breast cancer with pathologic residual tumors after preoperative chemotherapy(JBCRG-04)
Acronym
JBCRG-04(CREATE-X)
Scientific Title
A phase III randomized study of capecitabine as adjuvant chemotherapy versus observation in breast cancer with pathologic residual tumors after preoperative chemotherapy(JBCRG-04)
Scientific Title:Acronym
JBCRG-04(CREATE-X)
Region
| Japan | Asia(except Japan) |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study is designed to investigate the efficacy and safety of capecitabine, as a postoperative adjuvant chemotherapy, for breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy. In addition, the cost-effectiveness of capecitabine is to be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Disease free survival
Key secondary outcomes
Overall survival, safety, cost-effectiveness, Time to recurrence, time to death
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy (capecitabine)
Interventions/Control_2
Standard therapy (hormone therapy, radiotherapy)
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1. Female patient with primary, infiltrative breast cancer who has been diagnosed on a histological basis.
2. Stage I-IIIB at the first diagnosis and underwent curative resection.
3. The patient was non-pCR after preoperative chemotherapy including anthracycline agents; that is, she had undergone primary tumor resection and pathologically confirmed to have residual cancer cells. The previously adminstered preoperative chemotherapy must have involved at least four cycles of anthracycline agents. However, even if Anthracycline regimen is shorter than 4 courses, the following regimen can be registered.
- FEC 3 courses (EPI>=100mg/m2)+Docetaxel 3 courses
- FEC 3 courses+TC (Docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2) 3 courses
- TC 3 courses+FEC 3 courses
- TC only over 4 courses
4. The patient has been confirmed to be HER2 negative. etc.
5. The patient is aged 20 to 74
6. The patient's general performance status is 0 to 1.
7. The patient must have no carry-over of efficacy from any previous treatment.
8. The patient has maintained sufficient organ function to permit valid evaluation.
9. The patient must have no adverse drug reactions of grade 2 or higher carried over from previous treatment.
10. The ptient's creatinine clearance is higher than 50 mL/min
11. The patient has personally given written, informed consent to participate in this study.
Key exclusion criteria
1. The patient is considered to require postoperative chemotherapy other than capecitabine.
2. The patient has previously been treated with oral 5-FU agents (however, previous treatment with iv 5-FU is acceptable).
3. The patient has either simultaneous or non-simultaneous bilateral breast cancer.
4. The Patients has or has a history of other malignancies or synchronic multiple cancers. However, lesions corresponding to carcinoma in situ or intramucosal carcinoma healed by topical therapy are eligible.
5. The patient is pregnant, has the potential and/or wishes to become pregnant, or is breastfeeding.
6. The patient has previously had an organ transplant.
7. The patient shows hypersensitivity to fluoropyrimidine agents; has previously suffered severe adverse drug reactions with fluoropyrimidine agents; or has a history of serious hypersensitivity to LHRH analogs, tamoxifen, letrozole, anastrozole, and/or exemestane.
8. The patient is currently suffering from serious complications or associated disorders, such as malignant hypertension, congestive heart failure, coronary failure, arrhythmias requiring treatment, infectious diseases, and/or hemorrhagic tendency, and/or has suffered a myocardial infarction within the previous 6 months.
9. The patient has a fever, and there is the possibility that she has an infection.
10. The patient has been shown to have metastasis to other organs.
11. The patient requires treatment for epilepsy and/or central nervous system disorders.
12. The patient is currently being treated for, or has a history of, psychiatric disease.
13. It would be difficult to orally administer drugs to the patient, and/or she suffers from functional insufficiency of the upper gastrointestinal tract and/or malabsorption syndrome.
14. For any other reason, the investigator or sub-investigator has judged the patient to be ineligible for participation.
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Norikzau |
| Middle name | |
| Last name | Masuda |
Organization
Osaka National Hospital
Division name
Department of Surgery (Breast Oncology)
Zip code
540-0006
Address
1-14, 2-chome Hoenzaka, Chuou-ku, Osaka-city, Osaka
TEL
06-6942-1331
nmasuda@alpha.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
Organization
JBCRG
Division name
Head office
Zip code
103-0016
Address
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
office@jbcrg.jp
Sponsor or person
Institute
JBCRG (Japan Breast Cancer Research Group)
KBCS(Korean Breast Cancer Society)
KCSG(Korean Cancer Study Group)
Institute
Department
Personal name
Funding Source
Organization
ACRO (Advanced Clinical Research Organization),JBCRG (Japan Breast Cancer Research Group)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JBCRG
Address
9-4 Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
Tel
03-6264-8873
office@jbcrg.jp
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
(北海道)北海道大学病院Hokkaido University Hospital/ 北海道がんセンターHokkaido Cancer Center
(青森県)弘前市立病院Hirosaki Municipal Hospital
(岩手県)岩手医科大学附属病院Iwate Medical University
(宮城県)宮城県立がんセンターMiyagi Cancer Center
(群馬県)群馬県立がんセンターGunma Prefectural Cancer Center
(茨城県)土浦協同病院Tsuchiura Kyodo General Hospital
(栃木県)自治医科大学附属病院Jichi Medical University Hospital
(埼玉県)さいたま赤十字病院Saitama Red Cross Hospital
(東京都)多摩総合医療センターTokyo Metropolitan Tama Medical Center/ 東京都立駒込病院Tokyo Metropolitan Komagome Hospital/ 東京共済病院Tokyo Kyosai Hospital/ 国立がんセンター中央病院National Cancer Center Hospital/ 東京慈恵会医科大学附属病院The Jikei University Hospital/ 虎ノ門病院Toranomon Hospital/ 順天堂大学医学部附属順天堂病院Juntendo University Hospital
(神奈川県)東海大学医学部付属病院Tokai University Hospital/ 聖マリアンナ医科大学病院St. Marianna University School of Medicine Hospital/ 神奈川県立がんセンターKanagawa Cancer Center
(石川県)金沢大学医学部附属病院Kanazawa University Hospital
(福井県)福井赤十字病院Fukui Red Cross Hospital
(長野県)信州大学医学部附属病院Shinshu University School of Medicine/ 飯田市立病院Iida Municipal Hospital
(山梨県)山梨県立中央病院Yamanashi Prefectural Central Hospital
(愛知県)愛知県がんセンター中央病院Aichi Cancer Center Hospital/ 名古屋医療センターNagoya Medical Center/ 名古屋市立東部医療センター東市民病院Nagoya City East Medical Center/ 一宮市立市民病院Ichinomiya Municipal Hospital/ 名古屋市立大学病院Nagoya City University Hospital
(京都府) 京都大学医学部附属病院Kyoto University Hospital/ 京都民医連中央Kyoto Miniren Chuo Hospital
(大阪府)大阪医療センターOsaka National Hospital/ 堺市立総合医療センターSakai City Medical Center/ りんくう総合医療センターRinku General Medical Center/ 八尾市立病院Yao Municipal Hospital/大阪労災病院Osaka Rosai Hospital/大阪赤十字病院Osaka Red Cross Hospital/ 大阪警察病院Osaka Police Hospital/大阪市立大学医学部附属病院Osaka City University Hospital/関西医科大学附属枚方病院Kansai Medical University Hirakata Hospital/相原病院Aihara Hospital/ 大阪大学医学部附属病院Osaka University Hospital
(奈良県)市立奈良病院Nara City Hospital/ 奈良県立医科大学付属病院Nara Medical University Hospital
(和歌山県)公立那賀病院Naga Hospital
(兵庫県)兵庫県立がんセンターHyogo Cancer Center/ 兵庫医科大学病院Hyogo College of Medicine
(岡山県)岡山大学病院Okayama University Hospital
(広島県)広島市立安佐市民病院Hiroshima City Asa Citizens Hospital/ 広島市立広島市民病院Hiroshima City Hiroshima Citizens Hospital/ 済生会広島病院Saiseikai Hiroshima Hospital/ JA広島総合病院Hiroshima General Hospital/ 広島大学病院Hiroshima University Hospital/ 県立広島病院Hiroshima Prefectural Hospital
(山口県)山口大学医学部附属病院Yamaguchi University Hospital
(島根県)松江赤十字病院Matsue Red Cross Hospital
(愛媛県)四国がんセンターShikoku Cancer Center
(福岡県)九州がんセンターNational Hospital Organization Kyushu Cancer Center
(熊本県)熊本市立熊本市民病院Kumamoto City Hospital
(大分県)別府医療センターBeppu Medical Center
(鹿児島県)博愛会相良病院Social Medical Corporation Hakuaikai, Sagara Hospital
(沖縄県)中頭病院Nakagami Hospital
Samsung Medical Center
Seoul National University Bundang Hospital
Severance Hospital
Asan Medical Center
Yeungnam University Medical Center
National Cancer Center
Korea University Anam Hospital
Ajou University Hospital
Kyungpook National university hospital
Chungbuk National University Hospital
Soonchunhyang University Hospital Bucheon
Inje University Busan Paik hospital
Gangnam Severance Hospital
Hallym University Kangdong Sacred Heart Hospital
Gangneung Asan Hospital
Inha University Hospital
Seoul National University Hospital
Ewha Womans University Mokdong Hospital
Hallym University Sacred Heart Hospital
Konkuk University Medical Center
Soonchunhyang University Hospital Cheonan
Inje University Sanggye Paik Hospital
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://www.nejm.org/doi/full/10.1056/NEJMoa1612645
Number of participants that the trial has enrolled
910
Results
RESULTS:
DFS was longer in the capecitabine group than in the control group (74.1% vs. 67.6%). OS was longer in the capecitabine group than
in the control group (89.2% vs. 83.6%).
CONCLUSIONS:
After standard neoadjuvant chemotherapy, the addition of adjuvant capecitabine therapy was safe and effective in prolonging
DFS and OS among patients with HER2-negative breast cancer who had residual invasive disease on pathological testing.
Results date posted
| 2021 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
Breast cancer patients who have been pathologically confirmed to have residual cancer cells after the administration of preoperative chemotherapy involving anthracycline agents and the primary tumor resection (non-pCR patients).
Participant flow
Patients were randomly assigned equally to the capecitabine group and the control group (standard therapy) as postsurgical treatment.
Adverse events
The hand-foot syndrome, the most common adverse reaction to capecitabine, occurred in 73.4% of the patients in the capecitabine group.
Outcome measures
Primary endpoint: Disease-free survival (DFS)
Secondary endpoints: Overall survival (OS),safety
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2006 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 06 | Day |
Last modified on
| 2021 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000989
