Unique ID issued by UMIN | UMIN000012452 |
---|---|
Receipt number | R000014567 |
Scientific Title | Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy |
Date of disclosure of the study information | 2013/12/02 |
Last modified on | 2018/12/04 00:49:32 |
Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
(CYBORG-002)
Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
Phase II Trial of Pertuzumab plus Trastuzumab plus Docetaxel for HER2-Positive Metastatic Breast Cancer that Progressed During Prior Trastuzumab Therapy
(CYBORG-002)
Japan |
HER2-Positive Metastatic Breast Cancer
Breast surgery | Adult |
Malignancy
NO
The purpose is to assess the efficacy and the safety of pertuzumab plus trastuzumab plus docetaxel for HER2 positive metastatic breast cancer that progressed during prior trastuzumab therapy.
Safety,Efficacy
Phase II
Objective response rate
Progression free survival
Clinical benefit rate
Overall survival
Safety
Interventional
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 60-75 mg/m2 every 3 weeks.
18 | years-old | <= |
Not applicable |
Female
1. Patients who are 18 years or older with breast cancer which is confirmed to be invasive breast cancer by histological examination
2. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods
3. ECOG performance status(PS) is 0, 1 or 2
4. Patients with measurable lesions by Response Evaluation Criteria In Solid Tumors (RECIST)
5. The number of prior trastuzumab therapy is within 3 regimen.
6. Major organ function is maintained.
7. Left-ventricular ejection fraction (LVEF) is at least 50% at baseline.
8. Signed informed consent was obtained from patient.
1. Patients who have an active infection or high fever with suspicious infection.
2. Patients who have a history of cardiac disease, including known symptomatic decreases in LVEF to less than 50% absolute value during prior trastuzumab therapy or congestive heart failure.
3. Patients with pulmonary fibrosis or interstitial pneumonia that is clear from the chest X-ray
4. Patients with previous exposure to a cumulative dose of doxorubicin of more than 360 mg/m2
5. Patients with a decline in LVEF to less than 50% during or after former trastuzumab treatment
6. Patients suspected of being pregnant or pregnant women
7. Patients with another malignancy within the last 5 years
8. Patients with uncontrollable brain metastases
9. Patients who were considered by the primary care physician to be inappropriate as subjects of this trial
35
1st name | |
Middle name | |
Last name | Shin Takayama |
Tokyo Dental College Ichikawa General Hospital
Department of Surgery
5-11-13 Sugano, Ichikawa-shi, Chiba, JAPAN
047-322-0151
stakayama@tdc.ac.jp
1st name | |
Middle name | |
Last name | Mutsumi Ishi |
Tokyo Dental College Ichikawa General Hospital
Department of Pharmacy
5-11-13 Sugano, Ichikawa-shi, Chiba, JAPAN
047-322-0151
mishii@tdc.ac.jp
Chiba Youth Breast Oncology Research Group (CYBORG)
None
Self funding
NO
1)亀田総合病院(千葉県)
2)東京歯科大学市川総合病院(千葉県)
3)千葉県がんセンター(千葉県)
4)千葉大学医学部付属病院(千葉県)
2013 | Year | 12 | Month | 02 | Day |
Unpublished
Terminated
2013 | Year | 10 | Month | 02 | Day |
2013 | Year | 11 | Month | 26 | Day |
2021 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 01 | Day |
2018 | Year | 12 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014567
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |