ATEMPT 2.0: Adjuvant T-DM1 vs TH
A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0)
1 other identifier
interventional
500
1 country
53
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jun 2021
Longer than P75 for phase_2 breast-cancer
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedStudy Start
First participant enrolled
June 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 24, 2026
April 1, 2026
5.4 years
May 7, 2021
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of clinically relevant toxicities (CRT)
Compare the incidence of clinically relevant toxicities (CRT) in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine followed by trastuzumab SC to the incidence in those treated with paclitaxel in combination with trastuzumab SC as assessed by PRO-CTCAE
First 18 weeks of treatment
Disease Free Survival (DFS)
Evaluate disease-free survival in the T-DM1 followed by trastuzumab SC arm
Time from randomization to first Disease Free Survival (DFS) event up to 72 months
Secondary Outcomes (14)
Grade 3 and 4 adverse events
Enrollment to end of treatment up to 1 year
Quality of Life Assessment: FACT B
Enrollment to end of treatment up to 1 year
Symptoms related to therapy
Enrollment to end of treatment up to 1 year
Symptoms related to therapy
Enrollment to end of treatment up to 1 year
Effects of therapy on work productivity
Enrollment to end of treatment up to 1 year
- +9 more secondary outcomes
Study Arms (2)
Arm A. T-DM1 followed by Trastuzumab SC
EXPERIMENTALRandomized participants will receive intravenous T-DM1 every 3 weeks for 6 cycles (18 weeks) and then Trastuzumab SC (subcutaneous) every 3 weeks for 11 cycles
Arm B: Paclitaxel with Trastuzumab SC, followed by Trastuzumab SC alone
EXPERIMENTALRandomized participants will receive weekly intravenous Paclitaxel for 12 weeks (4 cycles) and Trastuzumab SC (subcutaneous) every 3 weeks for 17 cycles. The first 4 doses Trastuzumab SC are given with Paclitaxel.
Interventions
intravenous infusion
Muscular injection
intravenous infusion
Eligibility Criteria
You may qualify if:
- Patients must have HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mic) breast cancer according to the AJCC 8th edition anatomic staging table.
- If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. If an axillary dissection without sentinel lymph node biopsy is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed, and determined to be negative, for the patient to be considered node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\&E or immunohistochemistry (IHC) will be considered node-negative.
- Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.
- Patients who have an area of a T1aN0, ER+ (defined as \>10%), HER2-negative cancer in addition to their primary HER2-positive tumor are eligible.
- HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing. NOTE: HER-2 status must be confirmed to be positive by central review by NeoGenomics prior to patient starting protocol therapy. Patients previously having had HER2 immunohistochemical testing by NeoGenomics do not need to undergo retesting for central confirmation of HER2 status.
- NOTE: DCIS components will not be counted in the determination of HER2 status
- ER/PR determination is required. ER and PR assays should be performed by immunohistochemical methods according to the local institution standard protocol.
- Bilateral breast cancers that individually meet eligibility criteria are allowed.
- Patients with multifocal or multicentric disease are eligible, as long as each tumor individually meets eligibility criteria. Central confirmation is needed for any site of disease that is tested to be HER2-positive by local testing (unless testing was previously done by NeoGenomics).
- Patients with a history of ipsilateral DCIS are eligible if they were treated with wide excision alone, without radiation therapy, or treated with a mastectomy for this current breast cancer. Patients with a history of contralateral DCIS are not eligible.
- ≤ 90 days between the planned treatment start date and the patient's most recent breast surgery for this breast cancer
- ≥ 18 years of age with any menopausal status.
- ECOG Performance Status 0 or 1
- All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection
- All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed.
- +19 more criteria
You may not qualify if:
- Any of the following due to teratogenic potential of the study drugs:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDs, surgical sterilization, abstinence, etc.).
- Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc.).
- Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
- Patients with a history of previous invasive breast cancer.
- History of prior chemotherapy in the past 5 years.
- History of paclitaxel therapy
- Patients with active liver disease, for example due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis
- Individuals with a history of a different malignancy are ineligible except for the following circumstances:
- Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.
- Individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Genentech, Inc.collaborator
Study Sites (53)
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Smilow Cancer Hospital Care center at Derby
Derby, Connecticut, 06418, United States
Smilow Cancer Hospital Care center at Fairfield
Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital Care center at Glastonbury
Glastonbury, Connecticut, 06033, United States
Smilow Cancer Hospital Care center at Greenwich
Greenwich, Connecticut, 06830, United States
Smilow Cancer Hospital Care center at Guilford
Guilford, Connecticut, 06437, United States
Smilow Cancer Hospital Care center at St. Francis
Hartford, Connecticut, 06105, United States
Smilow Cancer Hospital Care center at Long Ridge
Long Ridge, Connecticut, 06902, United States
Yale Cancer Center at Yale University School of Medicine
New Haven, Connecticut, 06520-8028, United States
Smilow Cancer Hospital Care center at North Haven
North Haven, Connecticut, 06510, United States
Stamford Hospital
Stamford, Connecticut, 06904, United States
Smilow Cancer Hospital Care center at Torrington
Torrington, Connecticut, 06790, United States
Smilow Cancer Hospital Care center at Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital Care center at Waterbury
Waterbury, Connecticut, 06708, United States
Smilow Cancer Hospital Care center at Waterford
Waterford, Connecticut, 06385, United States
Miami Cancer Institute/Baptist Hospital of Miami
Miami, Florida, 33176, United States
Miami Cancer Institute - Plantation (MCIP)
Plantation, Florida, 33324, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Indiana University Health Joe & Shelly Schwarz Cancer Center
Carmel, Indiana, 46032, United States
IU Health North Hospital
Carmel, Indiana, 46032, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202, United States
Indiana University Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Eastern Maine Medical Center (Northern Light)
Brewer, Maine, 04412, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber at St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Mass General North Shore Cancer Center
Danvers, Massachusetts, 01923, United States
Dana-Farber Brigham Cancer Center - Foxborough
Foxborough, Massachusetts, 02035, United States
Dana-Farber Cancer Instiute - Merrimack Valley
Methuen, Massachusetts, 01844, United States
Dana-Farber at Milford
Milford, Massachusetts, 01757, United States
Newton Wellesley Hospital
Newton, Massachusetts, 02462, United States
Berkshire Medical Center
Pittsfield, Massachusetts, 01201, United States
Dana Farber at South Shore Hospital
Weymouth, Massachusetts, 02190, United States
NH Oncology-Hematology, PA - Payson Center for Cancer Care
Concord, New Hampshire, 03301, United States
Dana-Farber Cancer Insitute at Londonderry Hospital
Londonderry, New Hampshire, 03053, United States
Solinsky Center for Cancer Care (NH Oncology-Hematology, PA)
Manchester, New Hampshire, 03103, United States
New England Cancer Specialists - Portsmouth
Portsmouth, New Hampshire, 03801, United States
New York University Langone Hospital -Brooklyn
Brooklyn, New York, 11220, United States
New York University Langone Hospital - Long Island
Mineola, New York, 11501, United States
New York University Langone Health
New York, New York, 10016, United States
Northwell University
New York, New York, 10075, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27710, United States
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center Cancer UPMC- Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Smilow Cancer Hospital Care center at Westerly
Westerly, Rhode Island, 02891, United States
Greco-Hainsworth Centers for Research/Tennessee Oncology
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sara Tolaney, MD, PhD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 7, 2021
First Posted
May 19, 2021
Study Start
June 16, 2021
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
May 1, 2028
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.