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Brief Title: ATEMPT 2.0: Adjuvant T-DM1 vs TH
Official Title: 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)
Study ID: NCT04893109
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
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Smilow Cancer Hospital Care center at Derby, Derby, Connecticut, United States
Smilow Cancer Hospital Care center at Fairfield, Fairfield, Connecticut, United States
Smilow Cancer Hospital Care center at Glastonbury, Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care center at Greenwich, Greenwich, Connecticut, United States
Smilow Cancer Hospital Care center at Guilford, Guilford, Connecticut, United States
Smilow Cancer Hospital Care center at St. Francis, Hartford, Connecticut, United States
Smilow Cancer Hospital Care center at Long Ridge, Long Ridge, Connecticut, United States
Yale Cancer Center at Yale University School of Medicine, New Haven, Connecticut, United States
Smilow Cancer Hospital Care center at North Haven, North Haven, Connecticut, United States
Stamford Hospital, Stamford, Connecticut, United States
Smilow Cancer Hospital Care center at Torrington, Torrington, Connecticut, United States
Smilow Cancer Hospital Care center at Trumbull, Trumbull, Connecticut, United States
Smilow Cancer Hospital Care center at Waterbury, Waterbury, Connecticut, United States
Smilow Cancer Hospital Care center at Waterford, Waterford, Connecticut, United States
Miami Cancer Institute/Baptist Hospital of Miami, Miami, Florida, United States
Miami Cancer Institute - Plantation (MCIP), Plantation, Florida, United States
Indiana University Health Joe & Shelly Schwarz Cancer Center, Carmel, Indiana, United States
IU Health North Hospital, Carmel, Indiana, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
Indiana University Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana, United States
Eastern Maine Medical Center (Northern Light), Brewer, Maine, United States
New England Cancer Specialists, Scarborough, Maine, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber at St. Elizabeth's Medical Center, Brighton, Massachusetts, United States
Mass General North Shore Cancer Center, Danvers, Massachusetts, United States
Dana-Farber Brigham Cancer Center - Foxborough, Foxboro, Massachusetts, United States
Dana-Farber Cancer Instiute - Merrimack Valley, Methuen, Massachusetts, United States
Dana-Farber at Milford, Milford, Massachusetts, United States
Newton Wellesley Hospital, Newton, Massachusetts, United States
Berkshire Medical Center, Pittsfield, Massachusetts, United States
Dana Farber at South Shore Hospital, Weymouth, Massachusetts, United States
NH Oncology-Hematology, PA - Payson Center for Cancer Care, Concord, New Hampshire, United States
Dana-Farber Cancer Insitute at Londonderry Hospital, Londonderry, New Hampshire, United States
Solinsky Center for Cancer Care (NH Oncology-Hematology, PA), Manchester, New Hampshire, United States
State University of New York Downstate Medical Center, Brooklyn, New York, United States
New York University Langone Hospital - Long Island, Mineola, New York, United States
New York University Langone Health, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Duke Women's Cancer Care Raleigh, Raleigh, North Carolina, United States
Stefanie Spielman Comprehensive Breast Center, Columbus, Ohio, United States
University of Pennsylvania, Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Smilow Cancer Hospital Care center at Westerly, Westerly, Rhode Island, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Name: Sara Tolaney, MD, PhD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR