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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03430479
Recruitment Status : Unknown
Verified February 2018 by Kyoto Breast Cancer Research Network.
Recruitment status was:  Recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Information provided by (Responsible Party):
Kyoto Breast Cancer Research Network

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Cohort A Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : January 4, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cohort A Drug: Cohort A
Radiation + Nivolumab + hormone therapy

Experimental: Cohort B Drug: Cohort A
Radiation + Nivolumab + hormone therapy

Primary Outcome Measures :
  1. Phase Ib : dose-limiting toxicity rate [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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:


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03430479

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Contact: Kazuo Sakamoto +8175-761-5751

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Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Masakazu Toi    +8175-751-3660   
Principal Investigator: Masahiro Takada         
Sponsors and Collaborators
Kyoto Breast Cancer Research Network

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Responsible Party: Kyoto Breast Cancer Research Network Identifier: NCT03430479    
Other Study ID Numbers: kbcrnb002
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs