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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002365
Receipt No. R000002871
Scientific Title A phase III randomized study of neoadjuvant chemotherapy including trastuzumab + cyclophosphamide + docetaxel in patients with operable HER2 positive breast cancer (JBCRG 10)
Date of disclosure of the study information 2009/08/31
Last modified on 2019/03/22

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Basic information
Public title A phase III randomized study of neoadjuvant chemotherapy including trastuzumab + cyclophosphamide + docetaxel in patients with operable HER2 positive breast cancer
(JBCRG 10)
Acronym JBCRG-10
Scientific Title A phase III randomized study of neoadjuvant chemotherapy including trastuzumab + cyclophosphamide + docetaxel in patients with operable HER2 positive breast cancer
(JBCRG 10)
Scientific Title:Acronym JBCRG-10
Region
Japan

Condition
Condition HER2 positive breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The objective of the study is to investigate efficacy and safety of FEC therapy followed by TCH therapy, TCH therapy followed by FEC therapy and TCH therapy in an aim to improve pathological complete response (pCR) by neoadjuvant chemotherapy in operable HER2 positive breast cancer patients.
After June 2011 the protocol has been amended and TCH group is only entered.
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, incidence of cardiac disorders, clinical response rate, overall survival, breast conservation rate and rate without axillary lymph node dissection

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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)FEC-TCH therapy group: 4 cycles of FEC therapy * (5-fluorouracil (5-FU) + epirubicin (EPI) + cyclophosphamide (CPA)) followed by 4 cycles of TCH therapy ** (docetaxel (DTX) + cyclophosphamide (CPA) + trastuzumab (H))

*FEC regimen: 1 cycle is 3 weeks; 5-FU (500 mg/m2, q3w), epirubicin (100 mg/m2, q3w), cyclophosphamide (500 mg/m2, q3w)
**TCH regimen: 1 cycle is 3 weeks; docetaxel (75 mg/m2, q3w), cyclophosphamide (600 mg/m2, q3w)
Interventions/Control_2 2)TCH-FEC therapy group: 4 cycles of TCH therapy** followed by 4 cycles of FEC therapy
Interventions/Control_3 3)TCH therapy group: 6 cycles of TCH 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)Invasive lesion of the primary lesion is confirmed as HER2 positive (IHC 3+ or FISH+).
4)Status of ER and PgR are confirmed by immunohistochemical staining.
5)Age between 20 years old and 70 years old
6)ECOG performance status (PS): 0-1
7)Results from a laboratory test meet the following:
a)Leukocyte count is >=4000/mm3 and <=12 000/mm3 or neutrophil count is >=2000/mm3
b)Hemoglobin >=9.0g/dL
c)Platelet >=100 000/mm3
d)AST and ALT <=x 2.5 of upper limit of normal (ULN)
e)Bilirubin (total bilirubin or direct bilirubin) <=ULN
f)Serum creatinine <=x 1.5 of ULN
8)Baseline left ventricular ejection fraction (LVEF) is >=55% measured by echocardiography or MUGA scan.
9)No QTc prolongation by electrocardiography (QTc is <=470 msec).
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.
11)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
12)Multiple primary cancer or has history of multiple primary cancer in the past 5 years. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer.
13)History of invasive breast 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 agents.
16)Cardiac disorder diagnosed by echocardiography.
17)Women who are pregnant, lactating or with childbearing potential.
18)Ineligible based on decision of an investigator.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Toi1), Norikazu Masuda2), Takayuki Ueno3)
Organization 1)Kyoto University Hospital, 2)Osaka National Hospital,3)Kyorin University Hospital
Division name 1)Breast Surgery, 2)Department of Surgery (mastology)3)Department of Breast Surgery
Zip code
Address 1) 54 Syougoinkawaracho, sakyou-ku, kyouto-City, Kyoto, 2) 1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka, 3)6-20-2,Shinkawa, Mitaka-shi, Tokyo
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)、新潟県立がんセンター(新潟県)、大阪赤十字病院(大阪府)、大阪労災病院(大阪府)、広島市民病院(広島県)、熊本大学医学部附属病院(熊本県)、岩手医科大学(岩手県)、京都大学医学部附属病院(京都府)、群馬県立がんセンター(群馬県)、北海道がんセンター(北海道)、横浜旭中央総合病院(神奈川県)、虎の門病院(東京都)、兵庫医科大学(兵庫県)、九州がんセンター(福岡県)、筑波大学病院(茨城県)

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Presentation: SABCS(2012) 
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 07 Month 14 Day
Date of IRB
2009 Year 07 Month 31 Day
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2018 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
2009 Year 08 Month 21 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002871

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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