Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer

NCT04220203 | Unknown

• 1 other identifier: SGNTUC-021
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this program is to provide access to tucatinib in the United States before FDA approval. Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib. All treatments will be given on a 21 day cycle. To learn more about this program, contact Seattle Genetics' Medical Information (medinfo@seagen.com).

Conditions

HER2-positive Breast Cancer

Interventions

Tucatinib DRUG

300 mg orally two times per day

Capecitabine DRUG

1000 mg/m\^2 orally two times per day on Days 1-14 of each 21-day cycle

Trastuzumab DRUG

Loading dose of 8 mg/kg into the vein (IV; intravenously), followed by 6 mg/kg IV once per 21-day cycle

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have histologically confirmed HER2+ breast carcinoma, with HER2+ defined by ISH or FISH or IHC methodology
• For patients WITHOUT presence or history of brain metastases, have received previous treatment with trastuzumab, pertuzumab, and T-DM1
• For patients WITH presence or history of brain metastases, have received previous treatment with trastuzumab
• Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by treating physician), or be intolerant of last systemic therapy
• Have measurable disease or non-measurable disease assessable by standard of care imaging methods
• Have ECOG PS 0 or 1
• Have a life expectancy of at least 6 months, in the opinion of the treating physician

You may not qualify if:

• Eligible for a tucatinib clinical trial
• Disease recurrence within 3 months of last capecitabine for metastatic disease
• History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or biologically similar to tucatinib, except for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the protocol drugs
• Have received treatment with any systemic anti-cancer therapy (excluding hormonal therapy), non-CNS radiation, or experimental agent ≤ 3 weeks of first dose of protocol treatment or are currently participating in an interventional clinical trial. Have received hormonal therapies \<1 week of the first dose of protocol treatment.
• Have any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:
• Alopecia and neuropathy, which must have resolved to ≤ Grade 2
• CHF, which must have been ≤ Grade 1 in severity at the time of occurrence, and must have resolved completely
• Anemia, which must have resolved to ≤ Grade 2
• Have clinically significant cardiopulmonary disease
• Have known myocardial infarction or unstable angina within 6 months prior to first dose of protocol treatment
• Are known carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease with uncontrolled disease
• Are known to be positive for HIV with uncontrolled disease
• Are pregnant, breastfeeding, or planning a pregnancy
• Require therapy with warfarin or other coumarin derivatives (non-coumarin anticoagulants are allowed)
• Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications

Sponsors & Collaborators

• Seagen, a wholly owned subsidiary of Pfizer: lead
• Parexel: collaborator

MeSH Terms

Interventions

tucatinib; Capecitabine; Trastuzumab

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 7, 2020
• Last Updated: June 26, 2025

Record last verified: 2025-06