Breast CancerPhase 1/2NCT03430479
Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer
A Phase 1/2 study testing Cohort A in people with Breast Cancer, run by Kyoto Breast Cancer Research Network at 1 site in Japan.
Trial summary
The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cohort A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 22 Jun 2017to 1 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort A
- Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells) .
- 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.
- Patients who have hormone therapy that can be expected for advanced /metastatic disease.
Show all 21Show fewer
- Cohort B
- Patients who have come to be non-responsive more than two line of chemotherapy
- Prior chemotherapy with anthracycline and taxane agent
- Cohort A and B
- Female patients who are histologically or cytologically confirmed to have breast cancer
- Patients who have distant metastatic lesion as follow
- More than one bone lesion for radiation therapy
- Patients with cancer confirmed to be HER2-negative.（
- Patients with a measurable lesion based on RECIST 1.1.
- Patients aged >= 20 years at informed consent
- Patients with ECOG PS of 0 to 1.
- Patients without any severe disorder in the major organs.
- Patients expected to survive for ≥ 90 days.
- 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
- Patients who have provided written informed consent themselves.
Who cannot join
- -
- Patients who have neuropathy (more than Grade 2)
- Patients with any active autoimmune disease or a history of known autoimmune disease.
- Patients who has a history of pneumonitis or interstitial lung disease.
- Active, untreated central nervous system metastasis.
- Patients with pericardial effusion, pleural effusion or ascites requiring treatment
Show all 12Show fewer
- Patients with uncontrolled diabetes mellitus
- Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment.
- Patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment.
- Pregnant or breast-feeding women.
- Prior therapy with Nivolumab, anti CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Patients considered ineligible for participation in this study by their attending physicians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib/II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer
The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Cohort A
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort ADrug
Radiation + Nivolumab + hormone therapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: Cohort A |
| Cohort B | Experimental | Not described Receives: Drug: Cohort A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib : dose-limiting toxicity rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start22 Jun 2017
- Primary completion30 Nov 2018
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto Breast Cancer Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430479
- Sponsor's protocol ID
- kbcrnb002
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2018
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Takada M, Yoshimura M, Kotake T, Kawaguchi K, Uozumi R, Kataoka M, Kato H, Yoshibayashi H, Suwa H, Tsuji W, Yamashiro H, Suzuki E, Torii M, Yamada Y, Kataoka T, Ishiguro H, Morita S, Toi M. Phase Ib/II study of nivolumab combined with palliative radiation therapy for bone metastasis in patients with HER2-negative metastatic breast cancer. Sci Rep. 2022 Dec 27;12(1):22397. doi: 10.1038/s41598-022-27048-3.
PubMed 36575361
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03430479
- Acronym / sponsor ID
- kbcrnb002
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kyoto Breast Cancer Research NetworkUniversity, hospital or other
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Cohort A |
| Cohort B | Experimental | Drug: Cohort A |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Cohort A
- Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells) .
- Patients must satisfy the following criteria for prior therapy:
- or Progressed while prior hormone therapy for advanced/metastatic breast cancer. Two previous line of hormone therapy for advanced/metastatic disease is allowed.
- Patients who have hormone therapy that can be expected for advanced /metastatic disease.
Key exclusion criteria (12 listed)
- -
- Patients who have neuropathy (more than Grade 2)
- Patients with any active autoimmune disease or a history of known autoimmune disease.
- Patients who has a history of pneumonitis or interstitial lung disease.
- Active, untreated central nervous system metastasis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort ARadiation + Nivolumab + hormone therapy | Drug | Cohort A, Cohort B |
Primary outcome
Phase Ib : dose-limiting toxicity rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 36575361Takada M, Yoshimura M, Kotake T, Kawaguchi K, Uozumi R, Kataoka M, Kato H, Yoshibayashi H, Suwa H, Tsuji W, Yamashiro H, Suzuki E, Torii M, Yamada Y, Kataoka T, Ishiguro H, Morita S, Toi M. Phase Ib/II study of nivolumab combined with palliative radiation therapy for bone metastasis in patients with HER2-negative metastatic breast cancer. Sci Rep. 2022 Dec 27;12(1):22397. doi: 10.1038/s41598-022-27048-3.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cohort A in people with Breast Cancer, run by Kyoto Breast Cancer Research Network at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib : dose-limiting toxicity rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.