Actively Recruiting
ATEMPT 2.0: Adjuvant T-DM1 vs TH
Led by Dana-Farber Cancer Institute · Updated on 2026-04-24
500
Participants Needed
53
Research Sites
358 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: * Trastuzumab-emtansine (T-DM1, Kadcyla) * Trastuzumab SC (Herceptin Hylecta) * Paclitaxel
CONDITIONS
Official Title
ATEMPT 2.0: Adjuvant T-DM1 vs TH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with Stage I HER2-positive invasive breast cancer confirmed by central testing
- Node-negative or micrometastases breast cancer per AJCC 8th edition staging
- Tumors removed by mastectomy or lumpectomy with clear margins; radiation required for lumpectomy patients
- ECOG performance status 0 or 1
- No more than 90 days between breast surgery and planned treatment start
- Adequate bone marrow, liver, and heart function
- Negative pregnancy test for premenopausal women
- Willing to use effective nonhormonal contraception during and 7 months after treatment
- Tumor tissue available for research
- Able to read and understand English for quality of life surveys (not required for study participation)
You will not qualify if you...
- Pregnant or nursing women
- Women of childbearing potential or men unwilling to use adequate contraception
- Locally advanced tumors with chest wall fixation or inflammatory changes
- History of previous invasive breast cancer
- Chemotherapy or paclitaxel therapy within the past 5 years
- Active liver disease such as hepatitis or autoimmune hepatic disorder
- History of other malignancies unless disease-free for at least 5 years or specific low-risk cancers
- Serious ongoing illnesses including active infections, renal failure requiring dialysis, active heart disease, uncontrolled hypertension, or significant psychiatric illness that limit study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
2
Smilow Cancer Hospital Care center at Derby
Derby, Connecticut, United States, 06418
Actively Recruiting
3
Smilow Cancer Hospital Care center at Fairfield
Fairfield, Connecticut, United States, 06824
Actively Recruiting
4
Smilow Cancer Hospital Care center at Glastonbury
Glastonbury, Connecticut, United States, 06033
Actively Recruiting
5
Smilow Cancer Hospital Care center at Greenwich
Greenwich, Connecticut, United States, 06830
Actively Recruiting
6
Smilow Cancer Hospital Care center at Guilford
Guilford, Connecticut, United States, 06437
Actively Recruiting
7
Smilow Cancer Hospital Care center at St. Francis
Hartford, Connecticut, United States, 06105
Actively Recruiting
8
Smilow Cancer Hospital Care center at Long Ridge
Long Ridge, Connecticut, United States, 06902
Actively Recruiting
9
Yale Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8028
Actively Recruiting
10
Smilow Cancer Hospital Care center at North Haven
North Haven, Connecticut, United States, 06510
Actively Recruiting
11
Stamford Hospital
Stamford, Connecticut, United States, 06904
Actively Recruiting
12
Smilow Cancer Hospital Care center at Torrington
Torrington, Connecticut, United States, 06790
Actively Recruiting
13
Smilow Cancer Hospital Care center at Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
14
Smilow Cancer Hospital Care center at Waterbury
Waterbury, Connecticut, United States, 06708
Actively Recruiting
15
Smilow Cancer Hospital Care center at Waterford
Waterford, Connecticut, United States, 06385
Actively Recruiting
16
Miami Cancer Institute/Baptist Hospital of Miami
Miami, Florida, United States, 33176
Actively Recruiting
17
Miami Cancer Institute - Plantation (MCIP)
Plantation, Florida, United States, 33324
Actively Recruiting
18
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
19
Indiana University Health Joe & Shelly Schwarz Cancer Center
Carmel, Indiana, United States, 46032
Active, Not Recruiting
20
IU Health North Hospital
Carmel, Indiana, United States, 46032
Active, Not Recruiting
21
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
22
Indiana University Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
23
Eastern Maine Medical Center (Northern Light)
Brewer, Maine, United States, 04412
Actively Recruiting
24
New England Cancer Specialists
Scarborough, Maine, United States, 04074
Actively Recruiting
25
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
26
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
27
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
28
Dana-Farber at St. Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135
Actively Recruiting
29
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Actively Recruiting
30
Mass General North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
Actively Recruiting
31
Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts, United States, 02035
Actively Recruiting
32
Dana-Farber Cancer Instiute - Merrimack Valley
Methuen, Massachusetts, United States, 01844
Actively Recruiting
33
Dana-Farber at Milford
Milford, Massachusetts, United States, 01757
Actively Recruiting
34
Newton Wellesley Hospital
Newton, Massachusetts, United States, 02462
Actively Recruiting
35
Berkshire Medical Center
Pittsfield, Massachusetts, United States, 01201
Actively Recruiting
36
Dana Farber at South Shore Hospital
Weymouth, Massachusetts, United States, 02190
Actively Recruiting
37
NH Oncology-Hematology, PA - Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
Actively Recruiting
38
Dana-Farber Cancer Insitute at Londonderry Hospital
Londonderry, New Hampshire, United States, 03053
Actively Recruiting
39
Solinsky Center for Cancer Care (NH Oncology-Hematology, PA)
Manchester, New Hampshire, United States, 03103
Actively Recruiting
40
New England Cancer Specialists - Portsmouth
Portsmouth, New Hampshire, United States, 03801
Actively Recruiting
41
New York University Langone Hospital -Brooklyn
Brooklyn, New York, United States, 11220
Actively Recruiting
42
New York University Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
43
New York University Langone Health
New York, New York, United States, 10016
Actively Recruiting
44
Northwell University
New York, New York, United States, 10075
Actively Recruiting
45
Duke University Medical Center
Durham, North Carolina, United States, 27710
Active, Not Recruiting
46
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States, 27710
Active, Not Recruiting
47
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
Actively Recruiting
48
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
49
University of Pittsburgh Medical Center Cancer UPMC- Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
50
Smilow Cancer Hospital Care center at Westerly
Westerly, Rhode Island, United States, 02891
Actively Recruiting
51
Greco-Hainsworth Centers for Research/Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
52
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
53
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sara Tolaney, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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