UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026046 |
|---|---|
| Receipt number | 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 | 2024/02/19 13:54:05 |
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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
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(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
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(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
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
075-585-7861
Homepage URL
info.kbcrnct@gmail.com
Sponsor or person
Institute
General Incorporated Association
Kyoto Breast Cancer Research Network
Institute
Department
Personal name
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
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
Completed
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
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029875
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