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

August 10, 2020 updated by: Kyoto Breast Cancer Research Network

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Durvalmab&Tremelimumab&Fulvestrant
Drug: Durvalmab&Tremelimumab&Fulvestrant
Durvalumab and Tremelimumab once in 4 weeks Durvalumab for 13 months Tremelimumab for initial 4 months Fulvestrant : At baseline, then week 2, week 4 and after that every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate based on RECIST1.1
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto Breast Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 22, 2017

Primary Completion (ACTUAL)

January 30, 2018

Study Completion (ACTUAL)

July 31, 2018

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (ACTUAL)

February 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 12, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kbcrnb001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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