MedTrace Logo

T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer

NCT04351230 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-05-26

No results posted yet for this study

Summary

This phase II trial studies how well T-DMI with or without abemaciclib works for the treatment of HER2-positive breast cancer that has spread to other places in the body (metastatic). T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called DM1. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers DM1 to kill them. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and abemaciclib may work better in treating patients with breast cancer compared to T-DM1 alone.

Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • HER2 Positive Breast Carcinoma
  • Metastatic Breast Carcinoma
  • Prognostic Stage IV Breast Cancer AJCC v8

Interventions

DRUG

Abemaciclib

Given IV

BIOLOGICAL

Trastuzumab Emtansine

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Academic and Community Cancer Research United

    lead OTHER

Principal Investigators

  • Ciara C O'Sullivan · Academic and Community Cancer Research United

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2022-02-16
Completion
2022-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04351230 on ClinicalTrials.gov