UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	KBCRN-B-001
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate based on RECIST1.1
Key secondary outcomes	Duration of response Disease control rate Progression-free survival Response rate based on irRECIST ORR(RECIST 1.1, irRECIST), DOR,DCR in continuous administration

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	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.
Key exclusion criteria	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.
Target sample size	33

Research contact person
Name of lead principal investigator	Masakazu Toi
Organization	Kyoto University Graduate School of Medicine
Division name	Breast Surgery
Address	54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, Japan
TEL	075-751-3660
Email	toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Kazuo Sakamoto
Organization	General Incorporated Association Kyoto Breast Cancer Research Network
Division name	KBCRN Study Office
Address	9-5 Higashimaruta-cho, Sakyo-ku, Kyoto 606-8395 Japan
TEL	075-761-5751
Homepage URL
Email	k-study@ibec-jp.com

Sponsor
Institute	Breast Cancer Research Network
Institute
Department

Funding Source
Organization	AstraZeneca
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 05 Day
Anticipated trial start date	2017 Year 12 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 08 Day
Last modified on	2019 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029938