NCT03430479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jun 2017

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

February 6, 2018

Last Update Submit

January 18, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Phase Ib : dose-limiting toxicity rate

    2 years

Study Arms (2)

Cohort A

EXPERIMENTAL
Drug: Cohort A

Cohort B

EXPERIMENTAL
Drug: Cohort A

Interventions

Cohort ADRUG

Radiation + Nivolumab + hormone therapy

Cohort ACohort B

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.
  • +6 more criteria

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Related Publications (1)

  • 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.

    PMID: 36575361DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 13, 2018

Study Start

June 22, 2017

Primary Completion

November 30, 2018

Study Completion

April 1, 2021

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

JP(1)