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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03430466
Recruitment Status : Unknown
Verified February 2018 by Kyoto Breast Cancer Research Network.
Recruitment status was:  Recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Kyoto Breast Cancer Research Network

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Durvalumab,Tremelimumab,Fulvestrant Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : January 4, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: Durvalmab&Tremelimumab&Fulvestrant Drug: Durvalumab,Tremelimumab,Fulvestrant



Primary Outcome Measures :
  1. Response rate based on RECIST1.1 [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430466


Locations
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Japan
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Masakazu Toi    +8175-751-3660    toi@kuhp.kyoto-u.ac.jp   
Principal Investigator: Eiji Suzuki         
Sponsors and Collaborators
Kyoto Breast Cancer Research Network

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Responsible Party: Kyoto Breast Cancer Research Network
ClinicalTrials.gov Identifier: NCT03430466    
Other Study ID Numbers: kbcrnb001
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Durvalumab
Fulvestrant
Tremelimumab
Antibodies
Hormones
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists