Unique ID issued by UMIN | UMIN000008955 |
---|---|
Receipt number | R000010476 |
Scientific Title | Randomized phase 2 study comparing maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab. |
Date of disclosure of the study information | 2012/09/24 |
Last modified on | 2019/05/17 16:00:32 |
Randomized phase 2 study comparing maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab.
CAPTURE
Randomized phase 2 study comparing maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab.
CAPTURE
Japan |
Breast cancer
Medicine in general | Hematology and clinical oncology | Breast surgery |
Malignancy
YES
To evaluate efficacy and safety of maintenance treatments with paclitaxel plus bevacizumab and endocrine agent in patients with inoperable or recurrent breast cancer who received prior endocrine treatment and achieved non progressive disease during induction treatment with paclitaxel plus bevacizumab.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
Progression free survival between randomization and first progression
Progression free survival between randomization and second progression
Progression free survival between first registration and first progression
Progression free survival between first registration and second progression
Response rate of induction treatment
Response rate of second treatment
Overall survival since randomization
Overall survival since first registration
Safety
Health Related QOL
The related study defines as below in the another protocol
Feasibility of biopsy
Alteration of immunohistochemistry between primary and metastatic tumor
Exploratory immunohistochemistry
Whole exon sequencing of genome
Interventional
Cross-over
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 |
After 6 cycles of induction treatment with paclitaxel plus bevacizumab, continue maintenance treatment with paclitaxel plus bevacizumab until disease progression, then perform endocrine treatment until disease progression
After 6 cycles of induction treatment with paclitaxel plus bevacizumab, perform maintenance treatment with endocrine agent until disease progression, then resume treatment with paclitaxel plus bevacizumab until disease progression
20 | years-old | <= |
75 | years-old | >= |
Female
1)Pathological or cytological confirmed breast cancer
2)Postmenopausal inoperable breast cancer with metastatic disease or recurrence
3)HER2 negative(IHC 0, 1, 2 or ISH<2.0)
4)Performance Status 0-2
5)Evaluable lesion by RECIST(eligible in case with bone metastasis alone or carcinomatous fluid retention)
6)Recurrence during adjuvant endocrine treatment, or within 6 months after finishing of adjuvant endocrine treatment. Disease progression on endocrine treatment for inoperable or recurrence.
Recurrence during adjuvant endocrine treatment, or within 6 months after finishing of adjuvant endocrine treatment Disease progression on endocrine treatment for inoperable or recurrence. Not adopt this criteria in multiple organs (lung or liver) metastasis
7)None or 1 regimen of prior chemotherapy for metastatic breast cancer
8)No influence of prior treatment
9)Maintained organ function
10)More than 3months life expectancy
11)Written informed consent
1)Prior treatment of bevacizumab
2)Allergy to paclitaxel
3)Brain metastasis with risk of bleeding
4)Pregnancy, nursing
5)Active hepatitis
6)Non-healing severe wound or traumatic bone fracture
7)Pleural effusion, ascites or pericardial effusion that requires drainage
8)Uncontrollable hypertension
9)Usage of antithrombotic agents
10)Continuous administration of corticosteroid
11)Symptomatic congestive heart failure, unstable angina, arrhythmia requiring treatment, myocardial infarction within 1 year
12)Idiopathic pulmonary fibrosis or interstitial pneumonitis
13)Symptomatic cerebral vascular disturbance, or its history within 1 year
14)Deep venous thrombosis or pulmonary infarction, or its history within 1 year
15)Perforation of digestive tract, or its history within 1 year
16)Plan of surgery with risk of bleeding
Double cancer within 5 years of disease free interval
17)Symptomatic dysfunctional peripheral neuropathy
18)Active peptic ulcer
19)Body temperature more than 38C
150
1st name | Yoshinori |
Middle name | |
Last name | Ito |
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Breast Medical Oncology, Breast Oncology Center
135-8550
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
03-3520-0111
yito@jfcr.or.jp
1st name | Michiko |
Middle name | |
Last name | Yago |
Secretariat of CAPTURE Clinical Trial
Registration Center
135-8550
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
03-3520-0111
michiko.yago@jfcr.or.jp
CAPTURE Clinical Trial Group
Breast Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research
Self funding
Cancer Institute Hospital, Japanese Foundation for Cancer Research
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
03-3520-0111
med.shinsa@jfcr.or.jp
NO
2012 | Year | 09 | Month | 24 | Day |
Unpublished
Terminated
2012 | Year | 06 | Month | 23 | Day |
2012 | Year | 09 | Month | 11 | Day |
2012 | Year | 10 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2012 | Year | 09 | Month | 21 | Day |
2019 | Year | 05 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010476