A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)
If a participant agrees to participate in this study she will be asked to undergo some
screening tests or procedures to confirm that she is eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if turns out
that she does not take part in this research study. If she has had some of these tests or
procedures recently, they may or may not have to be repeated. These tests and procedures
will include: a medical history, performance status, assessment of your tumor, blood tests,
cardiac tests, pregnancy test and a collection of tumor tissue. If these tests show that she
is eligible to participate in the research study, she will begin the study treatment. If she
does not meet the eligibility criteria, she will not be able to participate in this research
Because no one knows which of the study options is best, the participant will be
"randomized" into one of the study groups after she has had her breast surgery: Group A or
Group B. Randomization means that she is put into a group by chance. Neither the participant
nor the research doctor will choose what group she will be in. The participant will have a
one in three chance of being placed in any group. Approximately 375 study participants will
receive the study drug, while 125 study participants will receive the standard therapy of
trastuzumab and paclitaxel.
Group A participants will receive the study drug T-DM1 every three weeks by IV (intravenous
injection) for a total of 17 weeks.
Group B participants will receive the FDA-approved drugs Paclitaxel and Trastuzumab once per
week by IV for 12 weeks. Then beginning week 13, participants will receive Trastuzumab only
by IV injection every three weeks for the next 13 weeks.
During all cycles the participant will have a physical exam and tumor assessment.
The investigators would like to keep track of the participant's medical condition for the
next five years after the final dose of study drug. The investigators would like to do this
by regular visits every 6 months for 3 years after completion of study treatment, and then
once a year for the next two years. The investigators may ask for additional follow-up by
phone after completion of these visits.
Participants who undergo lumpectomy (breast conserving surgery) need to receive breast
radiation therapy to participate in this study. Participants who have undergone a mastectomy
may receive chest wall and lymph node radiation (as determined by discussion with their
physician). Radiation Therapy will begin after the conclusion of all study paclitaxel doses,
and after 12 weeks fo the study drug T-DM1.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease Free Survival in Patients Treated with T-DM1
Disease-free survival (DFS) in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine
Sara Tolaney, MD, MPH
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Dana-Farber Cancer Institute at Faulkner Hospital||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute at Milford Hospital||Milford, Massachusetts 01757|
|New Hampshire Oncology-Hematology, PA||Concord, New Hampshire 03301|
|Dana-Farber Cancer Insitute at Londonderry Hospital||Londonderry, New Hampshire 03053|