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 | Active Not Recruiting Phase 2 Results FDA Drug

• 3 other identifiers: 7119-001MK-7119-001jRCT2051200152
• Study Type: interventional
• Target: 66
• Locations: 3 countries
• Sites: 28

Brief 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%.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants

  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.

  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)

Secondary Outcomes (21)

• Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by ICR: All Participants

  From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first

• Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by Investigator Assessment (INV): Japanese Participants

  From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first

• Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by INV: All Participants

  From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first

• Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: All Participants

  From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first

• Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: Japanese Participants

  From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first

Study Arms (1)

Tucatinib + Trastuzumab + Capecitabine

EXPERIMENTAL

Participants will receive tucatinib plus trastuzumab plus capecitabine. Tucatinib 300 mg will be administered orally twice daily (BID). Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose thereafter, will be administered intravenously (IV) on Day 1 of each 21-day cycle. Capecitabine 1000 mg/m\^2 will be administered orally BID on Days 1-14 of each 21-day cycle. Tucatinib, trastuzumab and capecitabine treatment will continue until unacceptable toxicity, disease progression, death, withdrawal of consent or study closure.

Drug: Tucatinib; Biological: Trastuzumab; Drug: Capecitabine

Interventions

Tucatinib DRUG

Tucatinib 300 mg administered BID via oral tablet

Also known as: MK-7119, Tukysa

Tucatinib + Trastuzumab + Capecitabine

Trastuzumab BIOLOGICAL

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

Also known as: Herceptin, Herceptin Hylecta

Tucatinib + Trastuzumab + Capecitabine

Capecitabine DRUG

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

Also known as: Xeloda

Tucatinib + Trastuzumab + Capecitabine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (28)

Aichi Cancer Center Hospital ( Site 1013)

Nagoya, Aichi-ken, 464-8681, Japan

Location

Nagoya University Hospital ( Site 1021)

Nagoya, Aichi-ken, 466-8560, Japan

Location

National Cancer Center Hospital East ( Site 1002)

Kashiwa, Chiba, 2778577, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 1014)

Matsuyama, Ehime, 791-0280, Japan

Location

National Hospital Organization Hokkaido Cancer Center ( Site 1017)

Sapporo, Hokkaido, 003-0804, Japan

Location

Hokkaido University Hospital ( Site 1022)

Sapporo, Hokkaido, 060-8648, Japan

Location

Hyogo Cancer Center ( Site 1005)

Akashi, Hyōgo, 673-8558, Japan

Location

Hyogo College of Medicine Hospital ( Site 1019)

Nishinomiya, Hyōgo, 663-8501, Japan

Location

University of Tsukuba Hospital ( Site 1020)

Tsukuba, Ibaraki, 305-8576, Japan

Location

Kanagawa Cancer Center ( Site 1010)

Yokohama, Kanagawa, 241-8515, Japan

Location

Medical Corporation Nahanishikai Nahanishi Clinic ( Site 1016)

Naha, Okinawa, 901-0154, Japan

Location

Saitama Cancer Center ( Site 1018)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 1009)

Fukuoka, 811-1395, Japan

Location

Fukushima Medical University Hospital ( Site 1012)

Fukushima, 960-1295, Japan

Location

Hiroshima City Hiroshima Citizens Hospital ( Site 1024)

Hiroshima, 730-8518, Japan

Location

Social medical corporation Hakuaikai Sagara Hospital ( Site 1008)

Kagoshima, 892-0833, Japan

Location

Kumamoto Shinto General Hospital ( Site 1007)

Kumamoto, 862-8655, Japan

Location

National Hospital Organization Osaka National Hospital ( Site 1001)

Osaka, 540-0006, Japan

Location

Osaka International Cancer Institute ( Site 1004)

Osaka, 541-8567, Japan

Location

National Cancer Center Hospital ( Site 1003)

Tokyo, 104-0045, Japan

Location

Juntendo University Hospital ( Site 1025)

Tokyo, 113-0033, Japan

Location

The Cancer Institute Hospital of JFCR ( Site 1015)

Tokyo, 135-8550, Japan

Location

Showa University Hospital ( Site 1023)

Tokyo, 142-8666, Japan

Location

Tokyo Medical University Hospital ( Site 1006)

Tokyo, 160-0023, Japan

Location

Seoul National University Hospital ( Site 2003)

Seoul, 03080, South Korea

Location

Severance Hospital ( Site 2001)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 2002)

Seoul, 06351, South Korea

Location

National Cheng Kung University Hospital ( Site 3000)

Dawan, Tainan, 704, Taiwan

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tucatinib; Trastuzumab; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: April 8, 2021
• Primary Completion: July 17, 2023
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 9, 2026
• Results First Posted: August 9, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (24); TW (1); KR (3)