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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003283
Receipt No. R000003873
Scientific Title A randomized study of Docetaxel + Cyclophosphamide (TC), 5-fluorouracil + Epirubicin + Cyclophosphamide (FEC)-TC and TC-FEC as preoperative chemotherapy for hormone receptor positive and HER2 negative primary breast cancer JBCRG-09
Date of disclosure of the study information 2010/03/03
Last modified on 2019/03/28

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Basic information
Public title A randomized study of Docetaxel + Cyclophosphamide (TC), 5-fluorouracil + Epirubicin + Cyclophosphamide (FEC)-TC and TC-FEC as preoperative chemotherapy for hormone receptor positive and HER2 negative primary breast cancer
JBCRG-09
Acronym JBCRG-09
Scientific Title A randomized study of Docetaxel + Cyclophosphamide (TC), 5-fluorouracil + Epirubicin + Cyclophosphamide (FEC)-TC and TC-FEC as preoperative chemotherapy for hormone receptor positive and HER2 negative primary breast cancer
JBCRG-09
Scientific Title:Acronym JBCRG-09
Region
Japan

Condition
Condition hormone receptor positive and HER2 negative primary breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of 6 cycles of docetaxel and cyclophosphamide (TC), 3 cycles of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) followed by 3 cycles of TC (FEC-TC), and 3 cycles of TC followed by 3 cycles of FEC as preoperative chemotherapy in patients with hormone receptor positive and HER2 negative primary breast cancer randomized to receive either of these therapies
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes pathological complete rseponse rate
Key secondary outcomes Safety,Overall response rate,Disease-free survival,Overall surviva, Clinical response evaluation using various diagnostic imaging techniques

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1)TC therapy group:
6 cycles of TC therapy

TC therapy
Docetaxel : 75 mg/m2, 1h, day1
Cyclophosphamide : 600 mg/m2, 15-30min, day1
Interventions/Control_2 2)FEC-TC therapy group:
3 cycles of FEC therapy
followed by 3 cycles of TC therapy

FEC therapy group
Fluorouracil(5-FU) : 500 mg/m2, 15-30min, day1
Epirubicin (EPI) : 100 mg/m2, 5min, day1
Cyclophosphamide : 500 mg/m2, 15-30min, day1
Interventions/Control_3 3)TC-FEC therapy group:
3 cycles of TC therapy
followed by 3 cycles of FEC therapy
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)Female primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy.
2)Resectable primary breast cancer (T1c-3 N0-1 M0) and tumor size is 7 cm or smaller. Multiple ipsilateral breast cancer is eligible when at least 1 lesion meets the eligible criteria. However, each lesion has to be histologically evaluated.
3)Status of ER and PgR are confirmed by immunohistochemical staining, and Estorogen receptor(ER) and/or Progesterone receptor(PgR) positive.
4)HER2 expression is confirmed by Immunohistochemistry (IHC or FISH); and IHC=0-1+, OR if IHC 2+ -> FISH negative.
5)Age between 20 years old and 70 years old
6)Performance status (PS) 0-1.
7)Results from a laboratory test meet the following
(within 14days before registration):
Leukocyte count is >=4000/mm3 and <=12 000/mm3 or neutrophil count is >=2000/mm3
Hemoglobin >=9.0g/dL
Platelet >=100,000/mm3
AST and ALT <=x 2.5 of upper limit of normal (ULN)
total bilirubin or direct bilirubin <=ULN
Serum creatinine <=x 1.5 of ULN
8) Left ventricular ejection fraction (LVEF) is >=55% measured by echocardiography or MUGA scan.
9)No clinical abnormality by electrocardiography
10)No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan.
11)Evaluate images of the primary lesion before and after treatment by CT, MRI or ultrasound. The evaluation must be based on the same modality.
12)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy.
13)Considered eligible to neoadjuvant chemotherapy based on decision of the attending physician after considering other treatments such as surgery, chemotherapy, hormone therapy.
14)Urinary or serum HCG negative when menopause is not confirmed (excluding patients underwent ovariectomy or hysterectomy).
15)Signed written informed consent
Key exclusion criteria 1)Hypersensitivity to any agents necessary in the planned treatment.
2)Poorly controlled complication (malignant hypertension, myocardial infarction within 6 months, congestive heart failure, coronary insufficiency, arrhythmia which requires treatment, infection and bleeding).
3)Fever with suspected infection.
4)Symptoms of varicella.
5)Pleural effusion or cardiac effusion which requires treatment.
6)Serious edema.
7)Serious peripheral neuropathy
8)Complication which requires prior treatment with corticosteroid.
9)Regular use of H2 blocker.
10)Has history of or receiving treatment for serious psychiatric disorder case.
11)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
12)History of invasive breast cancer.
13)Multiple primary cancer .However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer.
14)History of multiple primary cancers in the past 5 years, excluding nonmelanoma skin cancer, cervical cancer, thyroid cancer, early gastric cancer and early colorectal cancer appropriately treated.
15)Prior treatment with anticancer case.
16)Women who are pregnant, lactating or with childbearing potential.
17)Ineligible based on decision of an investigator.
Target sample size 195

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi1), Norikazu Masuda2),
Organization 1)Kyoto University Hospital, 2)Osaka National Hospital
Division name 1)Breast Surgery, 2)Department of Surgery (mastology)
Zip code
Address 1) 54 Syougoinkawaracho, sakyou-ku, kyouto-City, Kyoto, 2) 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL 06-6942-1331
Email nmasuda@alpha.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumasa Kuroi
Organization Japan Breast Cancer Research Group (JBCRG)
Division name Adminstrative office
Zip code
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL 03-6264-8873
Homepage URL http://www.jbcrg.jp/
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization Japan Breast Cancer Research Group (JBCRG)
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
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 大阪医療センター(大阪府)
熊本大学医学部附属病院(熊本県)
群馬県立がんセンター(群馬県)
八尾市立病院(大阪府)
北海道がんセンター(北海道)
大阪労災病院(大阪府)
新潟県立がんセンター(新潟県)
虎の門病院(東京都)
広島大学病院(広島県)
杏林大学医学部附属病院(東京都)
小牧市民病院(愛知県)
兵庫医科大学(兵庫県)
大阪市立大学(大阪府)
及川病院(福岡県)
広島市民病院(広島県)
京都大学医学部附属病院(京都府)
中頭病院(沖縄県)
横浜旭中央総合病院(神奈川県)
九州がんセンター(福岡県)
長崎医療センター(長崎県)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 03 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 Completed
Date of protocol fixation
2009 Year 08 Month 07 Day
Date of IRB
2009 Year 10 Month 08 Day
Anticipated trial start date
2009 Year 10 Month 09 Day
Last follow-up date
2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 02 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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