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NCT04893109
ATEMPT 2.0: Adjuvant T-DM1 vs TH
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 Details
NCT ID NCT04893109
Phase PHASE2
Sponsor Dana-Farber Cancer Institute
Status RECRUITING
Cancer Type HER2 Positive Breast Cancer
Interventions trastuzumab-emtansine Trastuzumab SC Paclitaxel
Locations (sample) San Francisco, California, United States|37.77493,-122.41942 Derby, Connecticut, United States|41.32065,-73.089 Fairfield, Connecticut, United States|41.14121,-73.26373 Glastonbury, Connecticut, United States|41.71232,-72.60815 Greenwich, Connecticut, United States|41.02649,-73.62846
Key Eligibility Criteria
Patients must have HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or microm… 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-n… Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis. Patients with a micrometastasis are eligible. … 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.
For full eligibility, visit ClinicalTrials.gov .