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Neoadjuvant Study of Abemaciclib, Durvalumab, and an Aromatase Inhibitor Early Stage Breast Cancer

NCT04088032 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-07-16

No results posted yet for this study

Summary

The purpose of this study is to test the efficacy, safety and tolerability of a combination of immunotherapy and anticancer drugs presurgery in patients with hormone-receptor positive breast cancer.

Conditions

  • Breast Cancer Female
  • Locally Advanced Breast Cancer
  • Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

DRUG

Abemaciclib, durvalumab and aromatase inhibitor

Subjects will receive standard therapy with an aromatase inhibitor (exemestane, anastrozole, or letrozole), combined with the experimental treatment of abemaciclib and durvalumab

Sponsors & Collaborators

Principal Investigators

  • Alison Stopeck, MD · Stony Brook University

  • Lea Baer, MD · Stony Brook University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04088032 on ClinicalTrials.gov