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)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

April 8, 2021

Primary Completion Date

July 17, 2023

Study Completion Date

November 25, 2025

Conditions
Breast Cancer
Interventions
DRUG

Tucatinib

Tucatinib 300 mg administered BID via oral tablet

BIOLOGICAL

Trastuzumab

Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion

DRUG

Capecitabine

Capecitabine 1000 mg/m\^2 administered BID via oral tablet

Trial Locations (28)

704

National Cheng Kung University Hospital ( Site 3000), Dawan

2778577

National Cancer Center Hospital East ( Site 1002), Kashiwa

241-8515

Kanagawa Cancer Center ( Site 1010), Yokohama

901-0154

Medical Corporation Nahanishikai Nahanishi Clinic ( Site 1016), Naha

362-0806

Saitama Cancer Center ( Site 1018), Kitaadachi-gun

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 1009), Fukuoka

464-8681

Aichi Cancer Center Hospital ( Site 1013), Nagoya

466-8560

Nagoya University Hospital ( Site 1021), Nagoya

791-0280

National Hospital Organization Shikoku Cancer Center ( Site 1014), Matsuyama

003-0804

National Hospital Organization Hokkaido Cancer Center ( Site 1017), Sapporo

060-8648

Hokkaido University Hospital ( Site 1022), Sapporo

673-8558

Hyogo Cancer Center ( Site 1005), Akashi

663-8501

Hyogo College of Medicine Hospital ( Site 1019), Nishinomiya

305-8576

University of Tsukuba Hospital ( Site 1020), Tsukuba

960-1295

Fukushima Medical University Hospital ( Site 1012), Fukushima

730-8518

Hiroshima City Hiroshima Citizens Hospital ( Site 1024), Hiroshima

892-0833

Social medical corporation Hakuaikai Sagara Hospital ( Site 1008), Kagoshima

862-8655

Kumamoto Shinto General Hospital ( Site 1007), Kumamoto

540-0006

National Hospital Organization Osaka National Hospital ( Site 1001), Osaka

541-8567

Osaka International Cancer Institute ( Site 1004), Osaka

104-0045

National Cancer Center Hospital ( Site 1003), Tokyo

113-0033

Juntendo University Hospital ( Site 1025), Tokyo

135-8550

The Cancer Institute Hospital of JFCR ( Site 1015), Tokyo

142-8666

Showa University Hospital ( Site 1023), Tokyo

160-0023

Tokyo Medical University Hospital ( Site 1006), Tokyo

03080

Seoul National University Hospital ( Site 2003), Seoul

03722

Severance Hospital ( Site 2001), Seoul

06351

Samsung Medical Center ( Site 2002), Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY