Ireland
--:--IST
Active, not recruiting Phase 2

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)

NCT04721977 · tracked via the Priya Life Science South Korea tracker
Sponsor
Phase
Phase 2
Started
2021-04-08
Last updated
2026-09-10

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Tucatinib →Trastuzumab →Capecitabine →

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

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Has histologically confirmed HER2+ breast carcinoma * Has received previous treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and T-DM1 with the exception of when the use of taxanes is contraindicated or judged not to be the best treatment at the investigator's discretion * Has radiographically and/or histologically confirmed disease progression on last systemic anticancer treatment * Has adequate organ function * Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP and using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 30 days after receiving the last dose of tucatinib, 80 days after receiving the last dose of trastuzumab, or 180 days after receiving the last dose of capecitabine, whichever occurs last and agrees to not donate eggs during this period * Male participants refrain from donating sperm and are either abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after receiving the last dose of tucatinib and 90 days after receiving the last dose of capecitabine, whichever occurs last * Previously treated brain metastasis is stable or progressed, provided there is no clinical indication for immediate re-treatment Exclusion Criteria: * Has been previously treated with lapatinib within 12 months of starting study treatment * Has been previously treated with neratinib, afatinib, tucatinib or capecitabine * Has a history of exposure to doxorubicin, epirubicin, mitoxantrone, idarubicin, liposomal doxorubicin * Has had treatment with any systemic anti-cancer therapy including hormonal therapy, non-central nervous system (CNS) radiation or experimental agent ≤3 weeks before first dose of study treatment * Has any toxicity related to prior cancer therapies that has not resolved with the exception of alopecia, congestive heart failure, anemia * Has clinically significant cardiopulmonary disease * Has known myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment * Has any uncontrolled viral, bacterial or fungal infection within 14 days prior to the first dose of study treatment * Is positive for Hepatitis B, Hepatitis C or has known chronic liver disease * Is known to be positive for human immunodeficiency virus (HIV) * Has evidence within 2 years of the start of study treatment of another malignancy that required systemic treatment * Has ongoing use of systemic corticosteroids for control of symptoms of brain metastases * Has any brain lesion thought to require immediate local therapy * Has known or suspected leptomeningeal disease (LMD) * Has poorly controlled generalized or complex partial seizures or manifest neurologic progression due to brain metastases

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)

FacilityCityRegionStatus
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
Official registry record

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.

View NCT04721977 on ClinicalTrials.gov ↗ ← All trials in South Korea