Actively Recruiting
Randomized Phase II Trial of Trastuzumab Emtansine Followed by Subcutaneous Trastuzumab Versus Paclitaxel with Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer
Led by Dana-Farber Cancer Institute · Updated on 2026-04-24
500
Participants Needed
53
Research Sites
78 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
Researchers are evaluating how newly diagnosed Stage I HER2-positive invasive breast cancer responds to one of two different combinations of HER2-directed therapies after surgery. The study compares the effects and side effects of trastuzumab-emtansine (T-DM1) followed by subcutaneous trastuzumab versus paclitaxel combined with subcutaneous trastuzumab. This phase II randomized trial also aims to understand the long-term benefits and disease-free survival for participants treated with these therapies. Participants are randomly assigned to one of two treatment groups. The first group receives intravenous T-DM1 every three weeks for six cycles, followed by subcutaneous trastuzumab every three weeks for eleven cycles. The second group receives weekly intravenous paclitaxel for twelve weeks alongside subcutaneous trastuzumab every three weeks for the first four doses, then continues with trastuzumab alone every three weeks for seventeen cycles. Treatment lasts about one year in total. During the study, participants undergo screening and regular evaluations including laboratory tests and follow-up visits. Researchers monitor the occurrence of clinically relevant toxicities during the first 18 weeks and track disease-free survival for up to 72 months. Additional assessments include quality of life, symptoms related to therapy, side effects, cardiac function, gene profiling, and overall survival. Participants will be followed for five years after completing treatment to assess long-term outcomes.
CONDITIONS
Brief Title
ATEMPT 2.0: Adjuvant T-DM1 vs TH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have HER2-positive Stage I invasive breast cancer confirmed by specific tests
- Must have node-negative or micrometastases breast cancer per staging guidelines
- HER2 status confirmed centrally by NeoGenomics before treatment
- ER and PR hormone receptor status determined by immunohistochemistry
- Bilateral or multifocal breast cancers allowed if each tumor meets criteria
- History of ipsilateral DCIS allowed with certain treatments; contralateral DCIS not allowed
- Treatment start must be within 90 days of most recent breast surgery
- Age 18 years or older, any menopausal status
- ECOG performance status of 0 or 1
- Tumors removed by mastectomy or lumpectomy with clear margins
- Breast conservation patients must be eligible for radiation therapy
- Up to 4 weeks of prior hormonal therapy allowed; none during first 12 weeks of study
- Prior oophorectomy allowed
- Partial breast radiation completed at least 2 weeks before starting study
- Participation in brief window studies before surgery allowed with required discontinuation
- Adequate bone marrow and liver function as defined by lab values
- Left ventricular ejection fraction of 50% or higher
- Negative pregnancy test for premenopausal patients
- Willingness to use specified non-hormonal contraception during and after treatment
- Availability of tumor tissue samples for research
- Able and willing to sign informed consent
- Ability to understand English for quality of life surveys; non-English speakers may participate but not complete surveys
You will not qualify if you...
- Pregnant or nursing women
- Women or men unwilling to use adequate contraception during the study
- Locally advanced tumors with specific features like fixation to chest wall or skin changes
- History of prior invasive breast cancer
- Chemotherapy within the last 5 years
- Prior treatment with paclitaxel
- Active liver disease such as hepatitis or autoimmune disorders
- History of other malignancies unless disease-free for 5 years or certain skin/cervical cancers
- Ongoing or unresolved infections or serious illness
- Renal failure requiring dialysis
- Active heart disease or heart failure
- Uncontrolled high blood pressure
- Significant psychiatric illness or other conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive one of two treatment regimens: either intravenous trastuzumab-emtansine (T-DM1) every 3 weeks for 18 weeks followed by subcutaneous trastuzumab every 3 weeks for about 33 weeks, or weekly intravenous paclitaxel for 12 weeks combined with subcutaneous trastuzumab every 3 weeks for 12 weeks followed by subcutaneous trastuzumab alone every 3 weeks for about 15 weeks.
Weekly visits for the first 12 to 18 weeks, then visits every 3 weeks for the remaining treatment period
Duration - 5 years
Participants are followed for 5 years after treatment to monitor long-term benefits and disease-free survival.
Periodic visits for follow-up assessments
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
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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