A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-0
Recruiting
Merck Sharp & Dohme Corp.
Phase 2
2021-04-08
The goal of this study is to evaluate the efficacy and safety of tucatinib in combination
with trastuzumab and capecitabine in participants with unresectable locally advanced or
metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent,
trastuzumab, pertuzumab and trastuzumab emtansine (T-DM1). The primary hypothesis is that the
confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors
version 1.1 (RECIST v1.1) as determined by independent central review (ICR) for the
combination of tucatinib, trastuzumab and capecitabine, is greater than 20%.
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
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
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