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

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ClinicalTrials.gov Identifier: NCT04220203
Expanded Access Status : Approved for marketing
First Posted : January 7, 2020
Last Update Posted : May 7, 2020
Information provided by (Responsible Party):
Seagen Inc.

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).

Condition or disease Intervention/treatment
HER2-positive Breast Cancer Drug: Tucatinib Drug: Capecitabine Drug: Trastuzumab

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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: Tucatinib
    300 mg orally two times per day
  • Drug: Capecitabine
    1000 mg/m^2 orally two times per day on Days 1-14 of each 21-day cycle
  • Drug: Trastuzumab
    Loading dose of 8 mg/kg into the vein (IV; intravenously), followed by 6 mg/kg IV once per 21-day cycle

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

No Contacts or Locations Provided
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT04220203    
Other Study ID Numbers: SGNTUC-021
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological
Protein Kinase Inhibitors
Enzyme Inhibitors