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-7119-001)
Condition(s) studied
Investigational drug(s) / intervention(s)
Tucatinib: Tucatinib 300 mg administered BID via oral tablet
Trastuzumab: Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion
Capecitabine: Capecitabine 1000 mg/m\^2 administered BID via oral tablet
Study summary
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%.
Eligibility
Primary outcome measure(s)
- Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants — From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first (maximum up to 17.8 months)
cORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR), per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to \<10 millimeter(mm). PR: a \>=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented progressive disease(PD) or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study(included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method.
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Aichi Cancer Center Hospital ( Site 1013) | Nagoya | Aichi-ken | |
| Nagoya University Hospital ( Site 1021) | Nagoya | Aichi-ken | |
| National Cancer Center Hospital East ( Site 1002) | Kashiwa | Chiba | |
| National Hospital Organization Shikoku Cancer Center ( Site 1014) | Matsuyama | Ehime | |
| National Hospital Organization Hokkaido Cancer Center ( Site 1017) | Sapporo | Hokkaido | |
| Hokkaido University Hospital ( Site 1022) | Sapporo | Hokkaido | |
| Hyogo Cancer Center ( Site 1005) | Akashi | Hyōgo | |
| Hyogo College of Medicine Hospital ( Site 1019) | Nishinomiya | Hyōgo | |
| University of Tsukuba Hospital ( Site 1020) | Tsukuba | Ibaraki | |
| Kanagawa Cancer Center ( Site 1010) | Yokohama | Kanagawa | |
| Medical Corporation Nahanishikai Nahanishi Clinic ( Site 1016) | Naha | Okinawa | |
| Saitama Cancer Center ( Site 1018) | Kitaadachi-gun | Saitama | |
| National Hospital Organization Kyushu Cancer Center ( Site 1009) | Fukuoka | Japan | |
| Fukushima Medical University Hospital ( Site 1012) | Fukushima | Japan | |
| Hiroshima City Hiroshima Citizens Hospital ( Site 1024) | Hiroshima | Japan | |
| Social medical corporation Hakuaikai Sagara Hospital ( Site 1008) | Kagoshima | Japan | |
| Kumamoto Shinto General Hospital ( Site 1007) | Kumamoto | Japan | |
| National Hospital Organization Osaka National Hospital ( Site 1001) | Osaka | Japan | |
| Osaka International Cancer Institute ( Site 1004) | Osaka | Japan | |
| National Cancer Center Hospital ( Site 1003) | Tokyo | Japan | |
| Juntendo University Hospital ( Site 1025) | Tokyo | Japan | |
| The Cancer Institute Hospital of JFCR ( Site 1015) | Tokyo | Japan | |
| Showa University Hospital ( Site 1023) | Tokyo | Japan | |
| Tokyo Medical University Hospital ( Site 1006) | Tokyo | Japan | |
| Seoul National University Hospital ( Site 2003) | Seoul | South Korea | |
| Severance Hospital ( Site 2001) | Seoul | South Korea | |
| Samsung Medical Center ( Site 2002) | Seoul | South Korea | |
| National Cheng Kung University Hospital ( Site 3000) | Dawan | Tainan |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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