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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental |
| |
| Cohort B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort A | Drug | Radiation + Nivolumab + hormone therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib : dose-limiting toxicity rate | 2 years |
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Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
-
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36575361 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |