MedTrace Logo

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

NCT03874325 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-05-31

Study results available
· View outcomes & findings →

Summary

This study is to find out if an investigational drug called Durvalumab (MEDI4736) given together with a standard of care aromatase inhibitor drug can help people with breast cancer.

Conditions

Interventions

DRUG

Durvalumab

1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

DRUG

Anastrozole 1mg

Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

DRUG

Letrozole 2.5mg

Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

DRUG

Exemestane 25 MG

Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Hung Khong, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-26
Primary Completion
2020-11-15
Completion
2021-01-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874325 on ClinicalTrials.gov