Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer

Conditions

Breast Cancer

Brief 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.

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.

2022-12-2715 citations

10.1038/s41598-022-27048-3

Predicting the efficacy of nivolumab combined with radiation therapy by longitudinal liquid biopsy with artificial intelligence for patients with metastatic breast cancer (translational research of the KBCRN-B-002 trial).

Kosuke Kawaguchi, Masahiro Takada, Takeshi Kotake, Michio Yoshimura, Ryuji Uozumi et al. (18 authors)

Journal of Clinical Oncology2020-05-20

10.1200/jco.2020.38.15_suppl.e15046

Abstract P3-09-07: A multicenter phase Ib/II study for evaluating safety and efficacy of Nivolumab in combination with radiation therapy in patients with HER2-negative metastatic breast cancer (KBCRN-B-002 trial)

Masahiro Takada, Michio Yoshimura, Kosuke Kawaguchi, Takeshi Kotake, Ryuji Uozumi et al. (23 authors)

Cancer Research2020-02-151 citations

10.1158/1538-7445.sabcs19-p3-09-07

Abstract P4-10-33: Alteration of the tumor immune microenvironment signatures by nivolumab combined with radiation therapy for patients with metastatic breast cancer (Translational Research of the KBCRN-B-002 trial)

Kosuke Kawaguchi, Masahiro Takada, Takeshi Kotake, Michio Yoshimura, Ryuji Uozumi et al. (23 authors)

Cancer Research2020-02-15

10.1158/1538-7445.sabcs19-p4-10-33

Interventions

DRUGCohort A

Radiation + Nivolumab + hormone therapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

No

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.

Exclusion criteria

\-

Design outcomes

Primary

Measure	Time frame
Phase Ib : dose-limiting toxicity rate	2 years

Countries

Japan

Outcome results

None listed