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

Breast Cancer Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT03430466
• Other study ID #: kbcrnb001
• Status: Terminated
• Phase: Phase 2
• Start date: June 22, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2020
• Source: Kyoto Breast Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 31, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto Breast Cancer Research Network

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate based on RECIST1.1		2 years