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)

JRCT ID: jRCT2051200152

Registered date:12/03/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Previously treated locally advanced unresectable or metastatic HER2+ breast carcinoma
• Date of first enrollment: 08/04/2021
• Target sample size: 55
• Countries of recruitment: Korea, Republic of,Japan,Taiwan,Japan
• Study type: Interventional

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
Other Name: Xeloda

Outcome(s)

• Primary Outcome: ORR per RECIST 1.1 as determined by independent central review in Japanese population.

Secondary Outcome

- ORR per RECIST 1.1 as determined by independent central review in all participants population.
- ORR per RECIST 1.1 as determined by investigator in Japanese population and all participants population.
- DOR and PFS per RECIST 1.1 as determined by independent central review and investigator in Japanese population and all participants population.
- OS
- Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Has histologically confirmed HER2+ breast carcinoma
- Has received previous treatment with trastuzumab, pertuzumab, and T-DM1
- Has radiographically and/or histologically confirmed disease progression on last systemic anticancer treatment for unresectable locally advanced or metastatic HER2+ breast carcinoma
- 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, 7 months 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

Exclude criteria

- Has been previously treated with lapatinib within 12 months of starting study treatment
- Has been previously treated with neratinib, afatinib, tucatinib or capecitabine for metastatic disease
- 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

Related Information

• Primary Sponsor: Ramos Jorge
• Secondary ID(s): NCT04721977