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)
Dana-Farber Cancer Institute
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
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 lo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- Drugtrastuzumab-emtansine
intravenous infusion
- DrugTrastuzumab SC
Muscular injection
- DrugPaclitaxel
intravenous infusion
Locations (53)
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Smilow Cancer Hospital Care center at DerbyDerby, Connecticut
- Smilow Cancer Hospital Care center at FairfieldFairfield, Connecticut
- Smilow Cancer Hospital Care center at GlastonburyGlastonbury, Connecticut
- Smilow Cancer Hospital Care center at GreenwichGreenwich, Connecticut
- Smilow Cancer Hospital Care center at GuilfordGuilford, Connecticut