ATEMPT 2.0: Comparing Two Treatments After Surgery for HER2-Positive Breast Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04893109

Provider View

This study is testing two different treatment combinations to see how well they work for people with newly diagnosed HER2-positive breast cancer after surgery. The treatments involve drugs that target the HER2 protein, which is found in some breast cancers.

Patient Parameters

Program Overview

The study is exploring how well two different combinations of drugs work in treating HER2-positive breast cancer after surgery. The drugs being tested are Trastuzumab-emtansine (T-DM1, Kadcyla), Trastuzumab SC (Herceptin Hylecta), and Paclitaxel. Researchers want to find out if these treatments can help control the cancer with fewer side effects and improve long-term outcomes.

Description

This study involves people with Stage I HER2-positive breast cancer. Participants will be randomly assigned to one of two treatment groups:

  • Group 1 will receive Trastuzumab-emtansine (T-DM1, Kadcyla) and Trastuzumab SC (Herceptin Hylecta).
  • Group 2 will receive Paclitaxel and Trastuzumab SC (Herceptin Hylecta).

The goal is to see if T-DM1 followed by Trastuzumab SC has fewer side effects than the traditional treatment of Trastuzumab and Paclitaxel. The study will also look at the long-term benefits and how long participants stay cancer-free.

T-DM1 is a targeted cancer therapy that combines an antibody with a chemotherapy drug. It specifically targets HER2-positive breast cancer cells, which may help limit the exposure of the rest of the body to chemotherapy. Trastuzumab SC is a form of Trastuzumab given as an injection under the skin. Paclitaxel and Trastuzumab are standard treatments for early breast cancer.

Participants will be treated for one year and followed for five years after treatment. About 500 people are expected to join this study. Genentech is supporting the study by providing funding and the study drugs.

Eligibility Criteria

Inclusion Criteria

  • Must have HER2-positive Stage I breast cancer confirmed by tests.
  • Cancer must not have spread to lymph nodes or only have small clusters of cancer cells in the lymph nodes.
  • Must be 18 years or older.
  • Must have had surgery to remove the tumor with clear margins.
  • Must be able to undergo radiation therapy if having breast-conserving surgery.
  • Must have adequate blood cell counts and organ function.
  • Must not be pregnant and agree to use effective contraception during the study and for 7 months after.
  • Must be able to provide a tumor sample for research.
  • Must be willing to sign informed consent and able to understand English for quality of life surveys.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • People unwilling to use contraception.
  • People with advanced tumors or previous invasive breast cancer.
  • People who have had chemotherapy in the past 5 years.
  • People with active liver disease or other serious health conditions that could interfere with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.