HER2-positive Breast CancerNCT04220203
Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
A study testing Tucatinib, Capecitabine and Trastuzumab in people with HER2-positive Breast Cancer, run by Seagen, a wholly owned subsidiary of Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Tucatinib, Capecitabine and Trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Have used strong CYP2C8 inhibitor within 5 half-lives of the inhibitor, or have used a CYP2C8 or CYP3A4 inducer within 5 day prior to start of tucatinib treatment.
- Have known dihydropyrimidine dehydrogenase deficiency
- Have evidence within 2 years of the start of protocol treatment of another malignancy that required systemic treatment.
- CNS Exclusion - patients must not have any of the following:
- Any untreated brain lesions > 2.0 cm in size, unless discussed with medical monitor and approval for enrollment is given
- Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent). However, patients on a chronic stable dose of ≤ 2 mg total daily of dexamethasone (or equivalent) may be eligible with discussion and approval by the medical monitor
- Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g. brain stem lesions).
- Known or suspected LMD as documented by the treating physician
- Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases notwithstanding CNS-directed therapy
About this study
Official title: A Multicenter, Open-label, Treatment Protocol of Tucatinib in Combination With Capecitabine and Trastuzumab in Patients With Previously Treated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
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
- Being tested
- Tucatinib, Capecitabine, Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucatinibDrug
300 mg orally two times per day
CapecitabineDrug
1000 mg/m^2 orally two times per day on Days 1-14 of each 21-day cycle
TrastuzumabDrug
Loading dose of 8 mg/kg into the vein (IV; intravenously), followed by 6 mg/kg IV once per 21-day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220203
- Sponsor's protocol ID
- SGNTUC-021
- Status last verified
- Jun 2025
- First submitted
- 3 Jan 2020
- Last updated
- 26 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Treatment Protocol of Tucatinib in Combination With Capecitabine and Trastuzumab in Patients With Previously Treated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
- ClinicalTrials.gov ID
- NCT04220203
- Acronym / sponsor ID
- SGNTUC-021
- Conditions
- HER2-positive Breast Cancer
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Seagen, a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (24 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tucatinib300 mg orally two times per day | Drug | – |
| Capecitabine1000 mg/m^2 orally two times per day on Days 1-14 of each 21-day cycle | Drug | – |
| TrastuzumabLoading dose of 8 mg/kg into the vein (IV; intravenously), followed by 6 mg/kg IV once per 21-day cycle | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tucatinib, Capecitabine and Trastuzumab in people with HER2-positive Breast Cancer, run by Seagen, a wholly owned subsidiary of Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.