Unique ID issued by UMIN | UMIN000026050 |
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Receipt number | R000029938 |
Scientific Title | Phase II study to assess efficacy, safety & immunological biomarker of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer |
Date of disclosure of the study information | 2017/02/08 |
Last modified on | 2019/02/07 06:04:51 |
Phase II study to assess efficacy, safety & immunological biomarker of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer
KBCRN-B-001
Phase II study to assess efficacy, safety & immunological biomarker of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer
KBCRN-B-001
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To evaluate efficacy and safety of anti-PD-L1 antibody drug + anti-CTLA-4 antibody drug in combination with hormone therapy in patients with inoperable or recurrent hormone-receptor-positive and HER2-negative breast cancer with distant metastasis. Also, the immunological biomarkers affecting therapeutic effect will be investigated.
Safety,Efficacy
Exploratory
Phase II
Response rate based on RECIST1.1
Duration of response
Disease control rate
Progression-free survival
Response rate based on irRECIST
ORR(RECIST 1.1, irRECIST), DOR,DCR in continuous administration
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Durvalumab 1500mg, every 4 weeks(up to 13 cycles)
Tremelimumab 75mg, every 4 weeks (up to 4 cycles)
Fulvestrant 500 mg, first day, 2weeks later and 4weeks laetr. And then every 4 weeks
20 | years-old | <= |
Not applicable |
Female
1)Patients aged >= 20 years at informed consent.
2)Patients who have provided written informed consent themselves.
3)Patients who have metastatic and/or advanced lesion
4)Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells).
5)Patients with cancer confirmed to be HER2-negative.
6)Patients with confirmed menopause
7)Patients who have plans of 2nd hormone therapy.
8)Patients with a measurable lesion based on RECIST 1.1
9)Patients with ECOG PS of 0 to 1.
10)Patients without any severe disorder in the major organs.
1)Active or prior documented autoimmune disease within the past 2 years.
2)Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
3)Patients with central nervous system metastasis
4)Patients with life-threatening disease.
5)Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.
6)Patients who have received live vaccination within 30 days before start of the investigational products.
7)Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.
8)Patients considered ineligible for participation in this study by their attending physicians.
33
1st name | |
Middle name | |
Last name | Masakazu Toi |
Kyoto University Graduate School of Medicine
Breast Surgery
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, Japan
075-751-3660
toi@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuo Sakamoto |
General Incorporated Association Kyoto Breast Cancer Research Network
KBCRN Study Office
9-5 Higashimaruta-cho, Sakyo-ku, Kyoto 606-8395 Japan
075-761-5751
k-study@ibec-jp.com
Breast Cancer Research Network
AstraZeneca
Other
NO
2017 | Year | 02 | Month | 08 | Day |
Unpublished
Terminated
2016 | Year | 12 | Month | 05 | Day |
2017 | Year | 12 | Month | 27 | Day |
2017 | Year | 02 | Month | 08 | Day |
2019 | Year | 02 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029938
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