ATEMPT 2.0: Adjuvant T-DM1 vs TH
Start Date
6/16/2021
Completion Date
5/1/2028
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
Detailed Description
This is a randomized phase II adjuvant study for women and men with Stage I HER2-positive invasive breast cancer. Participants will be randomized into one of two treatment arms in this study and receive: * Arm 1: trastuzumab-emtansine (T-DM1, Kadcyla) and trastuzumab SC (Herceptin Hylecta) * Arm 2: paclitaxel and trastuzumab SC (Herceptin Hylecta) This research study is looking to see if the study drug T-DM1 followed by trastuzumab SC will have less side-effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel.The study is also looking to learn about the long-term benefits and disease-free survival of participants who are treated with T-DM1 followed by trastuzumab SC. 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. The FDA (the U.S. Food and Drug Administration) has not approved T-DM1 for use on its own in patients with stage I, II, or III breast cancer. However, it has been approved for use in (a) advanced or metastatic, previously treated breast cancer and (b) in some patients receiving postoperative treatment after preoperative chemotherapy and surgery have been completed. Trastuzumab SC is a subcutaneous form of trastuzumab.Trastuzumab is a monoclonal antibody, which are disease-fighting proteins made by cloned immune cells. Paclitaxel and trastuzumab are considered a standard-of-care regimen in early breast cancer. Trastuzumab is FDA-approved to be administered as an IV (intravenous) or subcutaneous (muscular injection). The research study procedures include screening for eligibility and study treatment including laboratory evaluations and follow up visits. Participants will receive study treatment for a year in total and will be followed for 5 years after treatment. It is expected that about 500 people will take part in this research study. Genentech is supporting this research study by providing funding for the study and supplying trastuzumab-emtansine (T-DM1) and trastuzumab SC (subcutaneous).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
trastuzumab-emtansine
Trastuzumab SC
Paclitaxel
Conditions
Locations
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