ATOP Trial: Investigating T-DM1 for HER2 Positive Breast Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT03587740
This study is exploring the use of T-DM1, an investigational drug, as a potential treatment for HER2-positive breast cancer. T-DM1 is a targeted therapy that combines an antibody with chemotherapy to attack cancer cells.
Patient Parameters
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Program Overview
This research is a Phase II clinical trial, which means it is testing the safety and effectiveness of T-DM1, a drug not yet approved for early-stage breast cancer. T-DM1 is already approved for advanced HER2-positive breast cancer that has been previously treated. The study aims to understand the long-term benefits and side effects of T-DM1 in treating breast cancer. T-DM1 works by targeting HER2-positive cancer cells, delivering chemotherapy directly to them, which helps limit exposure to the rest of the body.
Description
This study is a Phase II clinical trial, focusing on the safety and effectiveness of T-DM1 for treating HER2-positive breast cancer. T-DM1 is a combination of an antibody (trastuzumab) and a chemotherapy drug (DM1), designed to target and kill cancer cells while minimizing side effects on the rest of the body. The trial aims to determine the long-term benefits of T-DM1 and to closely monitor any side effects experienced by participants.
T-DM1 is not yet approved by the FDA for early-stage breast cancer (stages I-III), but it is approved for advanced cases that have been previously treated. The drug works by binding to the HER2 protein on cancer cells, allowing the chemotherapy to enter and destroy them, which helps prevent tumor growth.
Participants in this study will receive T-DM1 to evaluate its effectiveness and safety. The study will also gather information on how well T-DM1 works in controlling breast cancer and what side effects it may cause.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed HER2-positive breast cancer, verified by specific tests.
- Age 60 or older, both men and women can participate.
- Must have stage I-III breast cancer with specific criteria for tumor size and lymph node involvement.
- Must have declined standard chemotherapy or be considered unsuitable for it by a doctor.
- Must have had all tumors removed by surgery, with clear margins.
- Must be within 90 days of the most recent breast surgery.
- Must have a good performance status and adequate heart function.
- Must have specific blood test results within normal ranges.
- Must have a life expectancy of more than 5 years.
- Must agree to use effective birth control if applicable.
- Must be willing to provide blood samples for research and return for follow-up visits.
- Must be able to understand and sign a consent form.
Exclusion Criteria
- Evidence of cancer spread to other parts of the body.
- Locally advanced tumors at diagnosis.
- Stage III, HER2-negative cancer in the other breast.
- Positive tests for active Hepatitis B or C.
- Active liver disease or significant heart problems.
- Uncontrolled illnesses or psychiatric conditions.
- Currently receiving other investigational treatments.
- History of another cancer with a high risk of relapse.
- Previous treatment with T-DM1 or similar drugs.
- More than 90 days of hormonal therapy for breast cancer.
- History of high doses of certain chemotherapy drugs.
- History of severe allergic reactions to similar treatments.
- Previous invasive breast cancer within the last 5 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| The Stamford Hospital | 06904 | Stamford | Connecticut |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Massachusetts General Hospital | 02215 | Boston | Massachusetts |
| Dana-Farber Cancer Institute at St. Elizabeth's Medical Center | 02135 | Brighton | Massachusetts |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center | 01757 | Milford | Massachusetts |
| Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital | 02190 | South Weymouth | Massachusetts |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Dana-Farber/New Hampshire Oncology-Hematology | 03053 | Londonderry | New Hampshire |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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