Unique ID issued by UMIN | UMIN000012444 |
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Receipt number | R000014562 |
Scientific Title | Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment |
Date of disclosure of the study information | 2013/11/29 |
Last modified on | 2013/11/29 16:20:16 |
Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment
Observational study of Pertuzumab in patients with HER2-positive MBC with the history of Trastuzumab treatment
Observational study of Pertuzumab in combination with Trastuzumab and Docetaxel in patients with metastatic HER2-positive breast cancer that have the history of Trastuzumab treatment
Observational study of Pertuzumab in patients with HER2-positive MBC with the history of Trastuzumab treatment
Japan |
metastatic breast cancer
Breast surgery |
Malignancy
NO
The purpose of this study was to assess the efficacy and the safety of Pertuzumab in combination with Trastuzumab and Docetaxel for HER2 positive metastatic breast cancer with the history of Trastuzumab treatment.
Efficacy
Time to strategy failure
Overall survival
Disease free survival
Response rate
Safety
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration of Pertuzumab and Trastuzumab with a starting dose of 840 mg and 8 mg/kg followed by 420 mg and 6 mg/kg as the second and subsequent doses and Docetaxel with a dose of 50-75 mg/m2 every 3 weeks.
18 | years-old | <= |
80 | years-old | >= |
Female
1. Patients recieving combination chemotherapy with Pertuzumab, Trastuzumab and Docetaxel.
2. Patients with breast cancer which is confirmed to be invasive breast cancer by histological examination.
3. Reccurent/inoperable HER2-positive breast cancer patients.
4. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods.
5. Patients with the history of Trastuzumab treatment
6. Patients with a performance status (ECOG) of 0, 1, or 2.
7. Left ventricular ejection fraction (LVEF) is equal or greater than 50% measured by cardiac ultrasonography.
8. Patients with adequately maintained organ and bone marrow functions.
9. Patients who provided written informed consent by themselves in principle to participate in this trial.
1. Male patients
2. Patients with allergy to the medicines in this protocol treatment.
3. Active infection or fever suspicious of infection.
4. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception.
5. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
20
1st name | |
Middle name | |
Last name | Hidemi Kawajiri |
Osaka City University Graduate School of Medicine
Department of Surgical Oncology
1-4-3 Asahi-machi, Abeno-ku, Osaka
06-6645-3838
hkawajiri75@yahoo.co.jp
1st name | |
Middle name | |
Last name | Hidemi Kawajiri |
Osaka City University Graduate School of Medicine
Department of Surgical Oncology
1-4-3 Asahi-machi, Abeno-ku, Osaka
06-6645-3838
hkawajiri75@yahoo.co.jp
Osaka City University Graduate School of Medicine
None
Self funding
NO
大阪市立大学医学部附属病院 乳腺内分泌外科病棟・外来(大阪府)
2013 | Year | 11 | Month | 29 | Day |
Unpublished
Enrolling by invitation
2013 | Year | 08 | Month | 19 | Day |
2013 | Year | 09 | Month | 12 | Day |
2016 | Year | 03 | Month | 31 | Day |
2013 | Year | 11 | Month | 29 | Day |
2013 | Year | 11 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014562
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