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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026050
Receipt No. 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

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Basic information
Public 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
Acronym KBCRN-B-001
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
Scientific Title:Acronym 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
1st name
Middle name
Last name Masakazu Toi
Organization Kyoto University Graduate School of Medicine
Division name Breast Surgery
Zip code
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
1st name
Middle name
Last name Kazuo Sakamoto
Organization General Incorporated Association Kyoto Breast Cancer Research Network
Division name KBCRN Study Office
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 12 Month 05 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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