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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

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 13, 2018
Last Update Posted Date February 13, 2018
Actual Study Start Date  ICMJE January 4, 2017
Estimated Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
Phase Ib : dose-limiting toxicity rate [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Cohort A
Radiation + Nivolumab + hormone therapy
Study Arms  ICMJE
  • Experimental: Cohort A
    Intervention: Drug: Cohort A
  • Experimental: Cohort B
    Intervention: Drug: Cohort A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 6, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2018
Estimated Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03430479
Other Study ID Numbers  ICMJE kbcrnb002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyoto Breast Cancer Research Network
Study Sponsor  ICMJE Kyoto Breast Cancer Research Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyoto Breast Cancer Research Network
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP