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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026046
Receipt No. R000029875
Scientific Title Phase Ib/II study to assess efficacy, safety & immunological biomarker of anti PD-1 antibody with radiation therapy in patients with HER-2-negative metastatic breast cancer
Date of disclosure of the study information 2017/02/08
Last modified on 2019/08/13

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Basic information
Public title Phase Ib/II study to assess efficacy, safety & immunological biomarker of anti PD-1 antibody with radiation therapy in patients with HER-2-negative metastatic breast cancer
Acronym KBCRN-B-002
Scientific Title Phase Ib/II study to assess efficacy, safety & immunological biomarker of anti PD-1 antibody with radiation therapy in patients with HER-2-negative metastatic breast cancer
Scientific Title:Acronym KBCRN-B-002
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety, antitumor effect and improved prognosis of Nivolumab with radiation therapy in patients with HER-2-negative metastatic breast cancer have bone metastasis that possible to irradiate.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase Ib
dose-limiting toxicity rate

Phase II
Response rate based on RECIST1.1
Key secondary outcomes Phase II
Duration of response
Disease control rate
Progression-free survival
Response rate based on irRECIST

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 Cohort A
Radiation + Nivolumab + hormone therapy

Cohort B
Radiation + Nivolumab
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 Cohort A
1) Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells) .
2) Patients must satisfy the following criteria for prior therapy:
- Progressed during treatment or within 12 months of completion of adjuvant hormone therapy.
or
- Progressed while prior hormone therapy for advanced/metastatic breast cancer.
Two previous line of hormone therapy for advanced/metastatic disease is allowed.
3) Patients who have hormone therapy that can be expected for advanced /metastatic disease.

Cohort B
4) Patients who have come to be non-responsive more than two line of chemotherapy
5) Prior chemotherapy with anthracycline and taxane agent

Cohort A and B
6) Female patients who are histologically or cytologically confirmed to have breast cancer
7) Patients who have distant metastatic lesion as follow
- More than one bone lesion for radiation therapy
8) Patients with cancer confirmed to be HER2-negative.
9) Patients with a measurable lesion based on RECIST 1.1.
10) Patients aged >= 20 years at informed consent
11) Patients with ECOG PS of 0 to 1.
12) Patients without any severe disorder in the major organs.
13) Patients expected to survive for >= 90 days.
14) Patients of childbearing potential must be using an acceptable method of contraception to avoid pregnancy and must not be breastfeeding for 18 weeks after the last dose of investigational product
15) Patients who have provided written informed consent themselves.
Key exclusion criteria 1) Patients who have neuropathy (more than Grade 2)
2) Patients with any active autoimmune disease or a history of known autoimmune disease.
3) Patients who has a history of pneumonitis or interstitial lung disease.
4) Active, untreated central nervous system metastasis.
5) Patients with pericardial effusion, pleural effusion or ascites requiring treatment
6) Patients with uncontrolled diabetes mellitus
7) Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment.
8) Patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment.
9) Pregnant or breast-feeding women.
10) Prior therapy with Nivolumab, anti CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
11) Patients considered ineligible for participation in this study by their attending physicians
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Masakazu
Middle name
Last name Toi
Organization Kyoto University Hospital
Division name Breast Surgery
Zip code 606-8507
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 toshiaki
Middle name
Last name SOMEHARA
Organization General Incorporated Association Kyoto Breast Cancer Research Network
Division name KBCRN Study Office
Zip code 601-8001
Address 1-10 Higashikujoumuromachi, MInami-ku, Kyoto 601-8001 Japan
TEL 050-5806-8031
Homepage URL
Email k-study@ibec-jp.com

Sponsor
Institute General Incorporated Association
Kyoto Breast Cancer Research Network
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO, LTD.
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 Kyoto University Certified Review Board
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, Japan
Tel 075-751-4389
Email tiken@kuhp.kyoto-u.ac.jp

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 32
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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 06 Day
Date of IRB
2016 Year 11 Month 22 Day
Anticipated trial start date
2017 Year 06 Month 22 Day
Last follow-up date
2018 Year 11 Month 30 Day
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 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029875

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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