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

NCT03430466 | Terminated Phase 2 DMC

• 1 other identifier: kbcrnb001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate based on RECIST1.1

  2 years

Study Arms (1)

Durvalmab&Tremelimumab&Fulvestrant

EXPERIMENTAL

Durvalmab\&Tremelimumab\&Fulvestrant

Drug: Durvalmab&Tremelimumab&Fulvestrant

Interventions

Durvalmab&Tremelimumab&Fulvestrant DRUG

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

Durvalmab&Tremelimumab&Fulvestrant

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyoto Breast Cancer Research Network: lead

Study Sites (1)

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 13, 2018
• Study Start: June 22, 2017
• Primary Completion: January 30, 2018
• Study Completion: July 31, 2018
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

JP (1)