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
NCT ID: NCT03430466
Last Updated: 2020-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2017-06-22
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Durvalmab&Tremelimumab&Fulvestrant
Durvalmab\&Tremelimumab\&Fulvestrant
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
FEMALE
No
Sponsors
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Kyoto Breast Cancer Research Network
OTHER
Responsible Party
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Locations
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Kyoto University Hospital
Kyoto, , Japan
Countries
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Other Identifiers
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kbcrnb001
Identifier Type: -
Identifier Source: org_study_id
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