Clinical Trials /

Nivolumab and Eribulin in HER2 Negative Metastatic Breast Cancer

NCT04061863

Description:

Cancer therapeutics such as chemotherapy may modulate tumor/immune-system interactions in favor of the immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor antigen delivery to antigen-presenting cells. Therefore, combining immunotherapy (Nivolumab) with chemotherapy (Eribulin) is a promising anti-cancer strategy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab and Eribulin in HER2 Negative Metastatic Breast Cancer
  • Official Title: A Phase IB/II, Single Arm, Multi-center Study of Nivolumab in Combination With Eribulin in HER2 Negative Metastatic Breast Cancer Patients

Clinical Trial IDs

  • ORG STUDY ID: KCSG BR18-16
  • NCT ID: NCT04061863

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
NivolumabOpdivoER+/HER2- breast cancer

Purpose

Cancer therapeutics such as chemotherapy may modulate tumor/immune-system interactions in favor of the immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor antigen delivery to antigen-presenting cells. Therefore, combining immunotherapy (Nivolumab) with chemotherapy (Eribulin) is a promising anti-cancer strategy.

Trial Arms

NameTypeDescriptionInterventions
ER+/HER2- breast cancerExperimentalwill be treated with a combination of eribulin and nivolumab
  • Nivolumab
ER-/HER2- breast cancerExperimentalwill be treated with a combination of eribulin and nivolumab
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Age 20 years or older

          -  ECOG performance status(PS) 0 or 1

          -  Histologically confirmed stage IV or recurrent breast cancer

          -  HER2 negative disease: not eligible for anti-HER2 therapy

             * HER2 negative [IHC 0, 1+ or IHC 2+ with corresponding ISH non-amplified or ratio
             less than 2.0 or ISH non-amplified ratio less than 2.0] as per ASCO-CAP HER2 guideline
             recommendations 2013 (ASCO-CAP)

          -  Patients previously treated with anthracycline and/or taxane unless contraindicated;
             Patients who received anthracycline and/or taxane based chemotherapy in either the
             neoadjuvant, adjuvant or metastatic setting and experienced disease progression on or
             after taxane-based chemotherapy in the metastatic setting

          -  No more than 3 prior lines of cytotoxic chemotherapy for metastatic disease; patients
             who experienced disease recurrence within 1 year after completion of (neo)adjuvant
             anthracycline and taxane-based chemotherapy will be counted as 1 prior line of
             treatment.; hormonal therapy will not be counted as a prior line of treatment

          -  Measurable disease according to RECIST v 1.1.

        Exclusion Criteria:

          -  Previous treatment with eribulin mesylate or any anti-PD-1, PD-L1, or PD-L2

          -  Active autoimmune disease that has required systemic treatment in the past 2 years
             (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive
             drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid
             replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a
             form of systemic treatment.

          -  Known central nervous system (CNS) disease, except for those subjects with treated
             brain metastasis who are stable for at least 1 month, having no evidence of
             progression or hemorrhage after treatment and no ongoing requirement for
             corticosteroids, as ascertained by clinical examination and brain imaging (magnetic
             resonance imaging [MRI] or computed tomography [CT]) during the screening period

          -  Known history of human immunodeficiency virus (HIV) positive

          -  Known active hepatitis B or hepatitis C (eg, HCV RNA detected)

          -  Any other malignancy that required treatment or has shown evidence of recurrence
             (except for nonmelanoma skin cancer, or histologically confirmed complete excision of
             carcinoma in situ) during the 3 years prior to enrollment in this study

          -  History of significant cardiovascular disease

          -  Hypersensitivity to the active substance or any other excipients of the eribulin
             mesylate drug product, or to nivolumab

          -  Scheduled for major surgery during the study

          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial
             treatment. The use of physiologic doses of corticosteroids may be allowed

          -  Has a history of (non-infectious) pneumonitis that required steroids or current
             pneumonitis

          -  Has a history of interstitial lung disease

          -  Has received a live-virus vaccination within 30 days of planned start of study
             therapy. Seasonal flu vaccines that do not contain live virus are permitted.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:6 months progression-free survival (PFS) rate
Time Frame:6 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate by RECIST criteria v 1.1
Time Frame:2 years
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:2 years (upto 5 years)
Safety Issue:
Description:
Measure:Incidence Rate of each Toxicity by CTCAE 4.0
Time Frame:2 years (upto 5 years)
Safety Issue:
Description:
Measure:Clinical benefit rate by RECIST criteria v 1.1 (and iRECIST)
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seoul National University Hospital

Trial Keywords

  • breast cancer
  • eribulin
  • nivolumab
  • immunotherapy
  • immune checkpoint inhibitor
  • metastatic breast cancer
  • PD-1

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