Unique ID issued by UMIN | UMIN000018202 |
---|---|
Receipt number | R000021051 |
Scientific Title | A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer(Study of Perjeta re-treatment for clinical outcomes) |
Date of disclosure of the study information | 2015/07/06 |
Last modified on | 2021/07/15 15:43:30 |
A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer(Study of Perjeta re-treatment for clinical outcomes)
JBCRG-M05(PRECIOUS)
A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Locally Advanced and Metastatic Breast Cancer(Study of Perjeta re-treatment for clinical outcomes)
JBCRG-M05(PRECIOUS)
Japan |
HER2-positive locally advanced or metastatic breast cancer
Hematology and clinical oncology | Surgery in general | Breast surgery |
Malignancy
NO
To evaluate the efficacy and safety of pertuzumab, trastuzumab and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in locally advanced or metastatic breast cancer patients for previously treated with pertuzumab
Safety,Efficacy
Exploratory
Explanatory
Phase III
Progression-free survival (assessed by investigators)
PFS (assessed by independent review), PFS in patients treated with trastuzumab emtansine (T-DM1) as the latest regimen, Response rate, Duration of response, Overall survival (OS), Patient-reported-outcome (QOL), Safety, biomarkers
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Trastuzumab + chemotherapy
Chemotherapy regimen is chosen from the following;
Docetaxel,Paclitaxel, nab-paclitaxel, vinorelbine, Eribulin, Capecitabine or Gemcitabine
Trastuzumab+ pertuzumab + chemotherapy
Chemotherapy regimen is chosen from the following;
Docetaxel, Paclitaxel, nab-paclitaxel, vinorelbine, Eribulin, Capecitabine or Gemcitabine
20 | years-old | <= |
Not applicable |
Female
1.Histologically or cytologically confirmed invasive breast cancer
2.A confirmed HER2-positive status assessed by means of immunohistochemical analysis(with 3+ indicating positive status)and/or in situ hybridization(with an amplification ratio>=2.0 indicating positive) by each institute
3.History of pertuzumab and trastuzumab-containing chemotherapy for locally advanced and metastatic breast cancer(2 or 3 regimen as previous chemotherapy regimen for locally advanced or metastatic breast cancer). The latest regimen before enrollment dose not include pertuzumab.
4.Patients have measurable and/or non-measurable disease according to RECIST ver1.1.
5.Female patients and aged >= 20 years.
6.Left Ventricular Ejection Fraction (LVEF) >= 50% at baseline (within 28 days before enrollment) as determined by either ECHO or MUGA
7. Eastern Cooperative Oncology Group performance status of 0,1 or 2.
8.Life expectancy of patients is expected at least 3 months.
9.Signed and written informed consent (approved by the Institutional Review Board or Independent Ethics Committee) is obtained before any study procedure.
1.History of chemotherapy>4 regimen for locally advance or metastatic disease except for cancer chemotherapeutic agent-free treatment regimen
2.Persistent Grade>=3 non-hematologic toxicity according to CTCAE v4.0 resulting from previous therapy at the time of enrollment
3.Symptomatic or uncontrolled central nervous system metastases
4.Multiple malignancies without history of breast cancer
5.History of exposure to the following cumulative doses of anthracyclines:
doxorubicin or liposomal doxorubicin>360mg/m2
epirubicin>720mg/m2
mitoxantrone>100mg/m2
If more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360mg/m2 of doxorubicin
6.Current uncontrolled hypertension or unstable angina
7.History of CHF of any NYHA criteria, or serious cardiac arrhythmia requiring treatment
8.History of myocardial infarction within 6 months of enrollment
9.Dyspnea at rest due to complications of advanced malignancy
10.Inadequate organ function, as determined by the following laboratory results, within 28 days before enrollment:
Absolute neutrophil count<1,500/mm3
Platelet count<100,000/mm3
Hemoglobin<8.0g/dL
Total bilirubin>2.0mg/dL, unless the patient has documented Gilbert's syndrome
AST or ALT >100IU/L
Serum creatinine value>2.0mg/dL or 177umol/L
11.Current severe uncontrolled systemic disease
12. Uncontrolled malignancy-associated hypercalcemia syndrome under bisphosphonates or denosumab treatment
13.Radiation related grade>=2 adverse event within 14 days before enrollment
14.Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of need for major surgery during the course of study treatment
15.Pregnant woman or positive pregnancy test
16.Nursing
17.History of receiving any investigational treatment within 28 days before enrollment
18.Current known and active infection with HIV
19.Receipt of intravenous antibiotics for infection within 14 days before enrollment
370
1st name | 1)Hiroji 2)Yutaka |
Middle name | |
Last name | 1)Iwata 2)Yamamoto |
1)Aichi Cancer Center
2)Kumamoto University Hospital
1)Department of Breast Oncology 2)Department of Breast and Endocrine Surgery
860-8556
2)1-1-1 Chuo-ku, Honjo, Kumamoto City, Kumamoto JAPAN
096-373-5521
ys-yama@triton.ocn.ne.jp
1st name | Jun |
Middle name | |
Last name | Fukase |
Japan Breast Cancer Research Group (JBCRG)
Head office
103-0016
3rd Floor, Nihonbashikoamicho9-4, Chuo-ku, Tokyo JAPAN
03-6264-8873
https://www.jbcrg.jp/
office@jbcrg.jp
Japan Breast Cancer Research Group (JBCRG)
Chugai Pharmaceutical Co., Ltd.
Profit organization
JAPAN
N/A
N/A
N/A
N/A
NO
愛知県がんセンター中央病院(愛知県)
熊本大学医学部附属病院(熊本県)
杏林大学医学部付属病院(東京都)
2015 | Year | 07 | Month | 06 | Day |
Unpublished
219
No longer recruiting
2015 | Year | 07 | Month | 04 | Day |
2015 | Year | 08 | Month | 11 | Day |
2015 | Year | 10 | Month | 06 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
2022 | Year | 06 | Month | 30 | Day |
2015 | Year | 07 | Month | 06 | Day |
2021 | Year | 07 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021051
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |