Study Comparing T-DM1 and Paclitaxel/Trastuzumab for Treating HER2+ Breast Cancer (ATEMPT Trial)

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT01853748

Provider View

This clinical trial is testing whether the drug T-DM1 is as effective and has fewer side effects than the standard treatment of paclitaxel and trastuzumab for patients with HER2-positive breast cancer.

Patient Parameters

Program Overview

This study is exploring the effectiveness of a drug called T-DM1 for treating HER2-positive breast cancer. T-DM1 is being tested to see if it can prevent the return of breast cancer with fewer side effects compared to the standard treatment of paclitaxel and trastuzumab. T-DM1 is already approved for treating advanced HER2-positive breast cancer, but its use in early-stage treatment is still being studied. The trial will compare the long-term benefits and disease-free survival of patients using T-DM1 against those using the standard treatment.

Description

If you decide to join this study, you will first undergo some tests to ensure you are eligible. These tests include a review of your medical history, a physical exam, blood tests, heart tests, and a pregnancy test if applicable. If you qualify, you will be randomly assigned to one of two groups after your breast surgery. This means you will be placed in a group by chance, not by choice.

Group 1 will receive the study drug T-DM1 every three weeks for a total of 51 weeks. Group 2 will receive the standard treatment of paclitaxel and trastuzumab for 12 weeks, followed by trastuzumab alone every three weeks for 39 weeks.

Throughout the study, you will have regular physical exams and assessments of your tumor. After completing the treatment, your health will be monitored for five years with regular visits every six months for the first three years, and then once a year for the next two years. Additional follow-up may be done by phone.

If you had a lumpectomy, you will need to receive radiation therapy to participate in this study. If you had a mastectomy, you may receive radiation therapy based on your doctor's recommendation. Radiation therapy will start after completing the paclitaxel doses or 12 weeks of T-DM1 treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with HER2-positive Stage I invasive breast cancer.
  • Must have specific hormone receptor tests done (ER/PR).
  • HER2 positive confirmed by specific lab tests.
  • Can have cancer in both breasts if each meets the criteria.
  • Can have multiple tumors if each meets the criteria.
  • History of certain types of breast cancer is allowed if treated without radiation.
  • Must provide a tumor tissue sample for testing.
  • Surgery for breast cancer must have been done within the last 90 days.
  • All cancer must be removed by surgery with clear margins.
  • May have had up to 4 weeks of hormonal therapy.
  • Prior preventive ovary removal is allowed.
  • Partial breast radiation before joining is allowed if completed two weeks before starting the study.
  • Must stop any investigational drugs two weeks before joining.
  • Must agree to use effective nonhormonal birth control during and after the study.

Exclusion Criteria

  • Pregnant or breastfeeding.
  • Using certain medications that affect the liver during the study.
  • Drinking more than 3 alcoholic drinks per day.
  • Having advanced tumors at diagnosis.
  • History of invasive breast cancer.
  • Received chemotherapy in the last 5 years.
  • Previously treated with trastuzumab or paclitaxel.
  • Having an active infection or liver disease.
  • History of another cancer unless disease-free for 5 years.
  • Having active heart disease.

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