ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03587740|
Recruitment Status : Active, not recruiting
First Posted : July 16, 2018
Last Update Posted : October 5, 2020
This research study is studying an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer.
The drug involved in this study is:
-ado-trastuzumab emtansine (T-DM1)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: T-DM1||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied and research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause.
The purpose of this research study is to examine the long-term benefits of T-DM1 with regard to breast cancer and take a closer look at the side effects experienced by participants receiving T-DM1.
The FDA (the U.S. Food and Drug Administration) has not approved T-DM1 for use in patients with stage I, II, or III breast cancer, but it has been approved for use in advanced, previously treated, HER2-positive breast cancer.
T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy. More specifically, the trastuzumab in T-DM1 first binds to the HER2 protein on the surface of the breast cancer cells and the DM1 then enters the cells and can cause them to die, preventing tumor growth
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ATOP TRIAL: Adjuvant Ado-Trastuzumab Emtansine (T-DM1) for Older Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2025|
T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.
T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.
Other Name: Kadcyla
- 5-year invasive disease-free survival rate [ Time Frame: 5 years ]To evaluate invasive disease-free survival (IDFS) for patient receiving T-DM1
- Recurrence-free survival [ Time Frame: 2 years ]To evaluate recurrence-free survival (RFS) for patient receiving T-DM1, defined as the time from study enrollment to disease recurrence and will not include death as an event.
- Overall Survival [ Time Frame: 2 years ]To evaluate overall survival (OS) for patient receiving T-DM1, defined as the time from study enrollment to death attributable to any cause (i.e. death from breast cancer, non-breast cancer cause, or from unknown cause).
- Site of first recurrence [ Time Frame: 2 years ]To evaluate site of first recurrence for patient receiving T-DM1, which will be tabulated as frequencies and relative frequencies.
- Incidence Rate of each Toxicity (Safety) [ Time Frame: 2 years ]To evaluate adverse events for patient receiving T-DM1, defined as adverse events of all grades utilizing CTCAE v4
- Incidence Rate of Cardiac-Related Adverse Events (left ventricular systolic dysfunction) [ Time Frame: 2 years ]To evaluate cardiac-related adverse events for patients receiving T-DM1, defined as incidence of symptomatic left ventricular systolic dysfunction
- Incidence Rate of Cardiac-Related Adverse Events (cardiac death) [ Time Frame: 2 years ]To evaluate cardiac-related adverse events for patients receiving T-DM1, defined as incidence of cardiac death
- Incidence Rate of Cardiac-Related Adverse Events (decreased ejection fraction) [ Time Frame: 2 years ]To evaluate cardiac-related adverse events for patients receiving T-DM1, defined as decrease in ejection fraction by at least 10 percentage points below baseline or to below 50%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587740
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|United States, Connecticut|
|The Stamford Hospital|
|Stamford, Connecticut, United States, 06904|
|United States, Maine|
|Eastern Maine Medical Center|
|Brewer, Maine, United States, 04412|
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Institute at St. Elizabeth's Medical Center|
|Brighton, Massachusetts, United States, 02135|
|Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center|
|Milford, Massachusetts, United States, 01757|
|Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital|
|South Weymouth, Massachusetts, United States, 02190|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New Hampshire|
|Dana-Farber/New Hampshire Oncology-Hematology|
|Londonderry, New Hampshire, United States, 03053|
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Rex Cancer Center|
|Raleigh, North Carolina, United States, 27607|
|United States, Rhode Island|
|Lifespan Cancer Institute|
|Providence, Rhode Island, United States, 02903|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Rachel Freedman, MD MPH||Dana-Farber Cancer Institute|