Clinical Trials /

Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer

NCT03430466

Description:

The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer
  • Official Title: Phase II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-L1 Antibody + Anti CTLA-4 Antibody in Combination With Hormone Therapy in Patients With Hormone Receptor Positive HER2-negative Recurrent or Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: kbcrnb001
  • NCT ID: NCT03430466

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Durvalumab,Tremelimumab,FulvestrantDurvalmab&Tremelimumab&Fulvestrant

Purpose

The aim of this study is to evaluate the safety and efficacy of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer.

Trial Arms

NameTypeDescriptionInterventions
Durvalmab&Tremelimumab&FulvestrantExperimental
  • Durvalumab,Tremelimumab,Fulvestrant

Eligibility Criteria

        Inclusion Criteria:

          1. Patients aged >= 20 years at informed consent.

          2. Patients who have provided written informed consent themselves.

          3. Patients who have metastatic and/or advanced lesion

          4. Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells).

          5. Patients with cancer confirmed to be HER2-negative.

          6. Patients with confirmed menopause

          7. Patients who have plans of 2nd hormone therapy.

          8. Patients with a measurable lesion based on RECIST 1.1

          9. Patients with ECOG PS of 0 to 1.

         10. Patients without any severe disorder in the major organs.

        Exclusion Criteria:

        Exclusion Criteria:

          1. Active or prior documented autoimmune disease within the past 2 years.

          2. Current or prior use of immunosuppressive medication within 28 days before the first
             dose of durvalumab or tremelimumab

          3. Patients with central nervous system metastasis

          4. Patients with life-threatening disease.

          5. Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or
             anti-CTLA-4 antibody drug.

          6. Patients who have received live vaccination within 30 days before start of the
             investigational products.

          7. Patients with a past medical history of pneumonia requiring steroid treatment or with
             a past medical history of interstitial pneumonia.

          8. Patients considered ineligible for participation in this study by their attending
             physicians.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response rate based on RECIST1.1
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Kyoto Breast Cancer Research Network

Last Updated