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Trial Compares HER2-positive Therapies in People With Early Breast Cancer

Phase III study needs 1,484 adults with early-stage, HER2-positive breast cancer

March 6, 2014

Written By Nicole Katze, MA, Editor and Manager, Publications
Reviewed By Adam Brufsky, MD, PhD & Aju Mathew, MD, MPhil

Researchers seek participants with early-stage, HER2-positive breast cancer for a phase III study. The trial team will explore which of two anti-HER2 medicines results in the longest invasive disease-free survival (IDFS), the time from starting the trial treatment to breast cancer:

  • returning to the same breast, or
  • to the lymph nodes closest to that breast, or
  • forming in the other breast. or
  • recurring in other organs such as bones, lungs, liver or brain

or to death from any cause.

Background and Goals                                           

The two medicines under study are both FDA-approved: trastuzumab for early-stage and metastatic breast cancer and T-DM1 for metastatic disease.   

The trial team will assess which medicine works better in people whose cancer was treated with chemotherapy before surgery, yet still remained in the breast or lymph nodes when examined under the microscope after surgery. To do so, they will collect data on each treatment’s impact on IDFS.

In addition they will collect data on overall survival, i.e, the time from the start of the trial treatment to death from any cause, and how safe the medicine is to use, including data on heart-related side effects.

Design

This study is open-label, which means both you and your doctor will know which medicine you are given. Those who take part will randomly be assigned to one of two treatment groups:

  • T-DM1 given by vein once every 3 weeks, for 14 cycles
  • Trastuzumab given by vein once every 3 weeks, for 14 cycles

If your doctors recommend it, you may also have radiation therapy or hormone therapy at their direction. All participants will be followed for up to 10 years.

Eligibility

You may be able to take part if you

  • are over age 18 and have early-stage, HER2-positive breast cancer
  • were treated with at least 9 weeks of trastuzumab and 9 weeks of taxane chemotherapy before surgery
  • had evidence of cancer cells in your breast or nearby lymph nodes at the time of surgery
  • had surgery no more than 12 weeks before joining the trial

You may not be eligible if you:

  • had cancer grow or spread during pre-surgery treatment
  • used a trial medicine within 28 days of starting this study
  • were treated with certain dosages of anthracycline chemotherapy
  • were treated with T-DM1 in the past

For more information or to find out if you are eligible, talk with your doctor about trial NCT01772472 on ClinicalTrials.gov.

Study Locations

This study is being carried out in 287 locations in the US and internationally. For full details and contact information, visit ClinicalTrials.gov.

Denver, CO  ·  September 13, 2014

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