UMIN-CTR Clinical Trial
|UMIN-CTR English Home||Glossary (Simple)||FAQ||Search clinical trials|
|Unique ID issued by UMIN||UMIN000002365|
|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|
|Public title||A phase III randomized study of neoadjuvant chemotherapy including trastuzumab + cyclophosphamide + docetaxel in patients with operable HER2 positive breast cancer
|Scientific Title||A phase III randomized study of neoadjuvant chemotherapy including trastuzumab + cyclophosphamide + docetaxel in patients with operable HER2 positive breast cancer
|Condition||HER2 positive breast cancer
|Classification by specialty||
|Classification by malignancy||Malignancy|
|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 objectives -Others|
|Developmental phase||Phase II|
|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
|Blinding||Open -no one is blinded|
|Institution consideration||Institution is considered as adjustment factor in dynamic allocation.|
|No. of arms||3|
|Purpose of intervention||Treatment|
|Type of intervention||
|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
|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
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.
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||
|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|
|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|
|Name of contact person||
|Organization||Japan Breast Cancer Research Group (JBCRG)|
|Division name||Adminstrative office|
|Address||9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan|
|Institute||Japan Breast Cancer Research Group (JBCRG)
|Organization||Japan Breast Cancer Research Group (JBCRG)
|Category of Funding Organization||Self funding|
|Nationality of Funding Organization||Japan|
|Other related organizations|
|Name of secondary funder(s)|
|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Partially published|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB||
|Anticipated trial start date||
|Last follow-up date||
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
|Link to view the page|
|Registered date||File name|
|Research case data specifications|
|Registered date||File name|
|Research case data|
|Registered date||File name|