- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03430466
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
-
-
-
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:
- Patients aged >= 20 years at informed consent.
- Patients who have provided written informed consent themselves.
- Patients who have metastatic and/or advanced lesion
- Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells).
- Patients with cancer confirmed to be HER2-negative.
- Patients with confirmed menopause
- Patients who have plans of 2nd hormone therapy.
- Patients with a measurable lesion based on RECIST 1.1
- Patients with ECOG PS of 0 to 1.
- Patients without any severe disorder in the major organs.
Exclusion Criteria:
-
Exclusion Criteria:
- Active or prior documented autoimmune disease within the past 2 years.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
- Patients with central nervous system metastasis
- Patients with life-threatening disease.
- Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.
- Patients who have received live vaccination within 30 days before start of the investigational products.
- Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.
- 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
|
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.
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
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Fulvestrant
- Tremelimumab
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.
Clinical Trials on Breast Cancer
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
Clinical Trials on Durvalmab&Tremelimumab&Fulvestrant
-
Canadian Cancer Trials GroupAstraZenecaActive, not recruiting
-
MedImmune LLCCompletedSquamous Cell Carcinoma of the Head and NeckUnited States, Canada
-
John L. Villano, MD, PhDActive, not recruitingTumor, SolidUnited States
-
Yonsei UniversityCompletedMetastatic Breast CancerKorea, Republic of
-
Samsung Medical CenterActive, not recruitingHead and Neck Squamous Cell CarcinomaKorea, Republic of
-
AstraZenecaCompletedMelanoma | Neoplasms | Renal Cell Carcinoma | Prostatic Neoplasms | Colorectal Neoplasms | Patients Who Have/Have Had Melanoma and Other TumorsUnited States, United Kingdom
-
MedImmune LLCCompletedDiffuse Large B-Cell LymphomaUnited States, France, United Kingdom, Ireland
-
Memorial Sloan Kettering Cancer CenterAstraZenecaCompletedAdenocarcinoma of the Bladder | Squamous Cell Carcinoma of the Bladder | Metastatic Bladder Cancer | Non-Transitional Cell Carcinoma of the Urothelial Tract | Small Cell of the BladderUnited States
-
University of Erlangen-Nürnberg Medical SchoolCompletedLocally Advanced Head and Neck Squamous Cell CarcinomaGermany
-
Centre Georges Francois LeclercAstraZenecaCompletedColorectal Cancer MetastaticFrance