Unique ID issued by UMIN | UMIN000007074 |
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Receipt number | R000008329 |
Scientific Title | Ki67 index guided selection of preoperative chemotherapy for HER2 positive breast cancer - a randomized phase 2 trial |
Date of disclosure of the study information | 2012/01/20 |
Last modified on | 2017/07/04 15:52:19 |
Ki67 index guided selection of preoperative chemotherapy for HER2 positive breast cancer - a randomized phase 2 trial
Ki67 index guided selection of preoperative chemotherapy - a randomized phase 2 trial
Ki67 index guided selection of preoperative chemotherapy for HER2 positive breast cancer - a randomized phase 2 trial
Ki67 index guided selection of preoperative chemotherapy - a randomized phase 2 trial
Japan |
HER2 positive breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To evaluate the usefulness of Ki67 index guided selection of preoperative chemotherapy for HER2 positive breast cancer.
Efficacy
Exploratory
Pragmatic
Phase II
Pathological complete response rate
Objective response rate
Disease-free survival
Overall survival
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Ki-67 based treatment arm:
Ki67 is evaluated after the first course of preoperative chemotherapy with trastuzumab and paclitaxel.
When the enough reduction in Ki67 is achieved, same regimen is continued for 3 cycles, followed by surgery.
When the enough reduction in Ki67 is not achieved, preoperative chemotherapeutic regimen is changed.
control arm:
Preoperative trastuzumab and paclitaxel for 4 cycles, followed by surgery
20 | years-old | <= |
75 | years-old | >= |
Female
(1) Histologically proven breast cancer (invasive ductal carcinoma)
(2) Stage2 or 3
(3) Women aged 20 to 75 years old
(4) HER2 positive breast cancer (IHC3+ or FISH+)
(5) LVEF is 55% and more
(6) Performance status (PS):0-1 (Eastern Cooperative Oncology Group ; ECOG)
(7) Sufficient organ functions
(8) No prior endocrine therapy or chemotherapy for breast cancer
(9) Written informed consent
(1) Simultaneous double cancers
(2) Metachronous or bilateral breast cancer
(3) Hypersensitivity to the drugs used in this study
(4) Prior or concurrent cardiac disease, such as congestive heart failure, myocardial infarction, ischemic heart disease, arrhythmia, valvular heart disease
(5) Uncontorolled hypertension
(6) Uncontorolled diabetes mellitus
(7) Inappropriate by the physician's judgment
200
1st name | |
Middle name | |
Last name | Hirofumi Mukai |
National Cancer Center Hospital East
Department of Hematology and Oncology
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan
1st name | |
Middle name | |
Last name | Takeshi Yamaguchi |
National Cancer Center Hospital East
Department of Hematology and Oncology
6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan
National Cancer Center Hospital East
Ministry of Health, Labour and Welfare
Japan
NO
国立がん研究センター東病院(千葉県)
大阪市立大学付属病院(大阪府)
四国がんセンター(愛媛県)
自治医科大学附属病院(東京都)
三重大学付属病院(三重県)
2012 | Year | 01 | Month | 20 | Day |
Unpublished
Completed
2011 | Year | 08 | Month | 03 | Day |
2011 | Year | 11 | Month | 01 | Day |
2017 | Year | 11 | Month | 01 | Day |
2012 | Year | 01 | Month | 16 | Day |
2017 | Year | 07 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008329
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