Unique ID issued by UMIN | UMIN000012256 |
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Receipt number | R000014329 |
Scientific Title | Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients. |
Date of disclosure of the study information | 2013/11/09 |
Last modified on | 2018/05/28 17:25:48 |
Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients.
KBC-SG 1201
Pase II study of neoadjuvant chemotherapy with Docetaxel, Carboplatin, and Trastuzumab for operable Her2-positive breast cancer patients.
KBC-SG 1201
Japan |
Her2-positive breast cancer
Hematology and clinical oncology | Surgery in general | Breast surgery |
Malignancy
NO
Evaluation of the anti-tumor effect of combination chemotherapy with Docetaxel, Carboplaitn, Trastuzumab in Her2-positive breast cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Pathological complete response rate.
Observational
20 | years-old | <= |
Not applicable |
Female
1. Women with histological confirmed invasive breast cancer at diagnosis.
2. Operable breast cancer. TMN:T1b-T3, N0-N2, M0
3. Her2(3+) by core needle biopsy before treatment and/or FISH(+)before registration.
4. At least one measurable region (RECIST version1.1).
5. No prior treatment for breast cancer.
6. PS:0-1
7. Adequate main organ function.
4000/mm3<=WBC <12000
and/or 2000/mm3<=neutorophil
PLT>=100000/mm3
AST, ALT<=ULN*2.5
T.Bil<=1.5mg/dl
Cr<=1.5mg/dl
Normal electrocardiogram.
LVEF: 55%<=
8. Written informed consent.
1.Clinically inadequate heart function at the registration and/or with past history.
2.Severe uncontrolled complications (Uncontrolled DM, HT, liver dysfunction, renal dysfunction, infection mental manifestation).
3.Women during pregnancy or shortly after childbirth.
4.Double active cancer (in less than 5 years after the last treatment).
5.Women with bilateral breast cancer (synchronous or heterochronous).
6.Women with pulmonary fibrosis and/or interstitial pneumonia.
7.Patients with allergy to the medicines in this protocol treatment.
8.Patients judged inappropriate for this study by the physicians.
30
1st name | |
Middle name | |
Last name | Kohjiro Mashino |
Oita Prefectural Hospital
Department of breast surgery
Bunyo 476, Oita city, Oita
097-546-7111
mashino@oitakenbyo.jp
1st name | |
Middle name | |
Last name | Kazuo Tamura |
Kyushu Breast Cancer Study Group
Organizer
7-45-1, Nanakuma, Jonan-ku, Fukuoka
092-801-2845
http://www.chotsg.com/kbc-sg/
kbc@chotsg.com
Kyushu Breast Cancer Study Group
Non-profit organization, Clinical Hematology Oncology Treatment Study Group
Other
Japan
NO
大分県立病院(大分県)、福岡大学病院(福岡県)
2013 | Year | 11 | Month | 09 | Day |
Unpublished
Completed
2013 | Year | 04 | Month | 24 | Day |
2013 | Year | 06 | Month | 01 | Day |
This study prospectively evaluate the anti-tumor effect , adverse event and tolerability of TCbH therapy in Japanese women.
2013 | Year | 11 | Month | 09 | Day |
2018 | Year | 05 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014329
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