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Protocol No.1654GCCPrincipal InvestigatorTkaczuk, Kate
PhasePhase II
Age GroupAdult
Title1654GCC: Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)
DescriptionThe purpose of this study is to assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central review.
TreatmentTucatinib vs. placebo in combination with capecitabine and trastuzumab
Key EligibilityTo find more information please go to clinicaltrials.gov and search: NCT02614794

Patients must meet the following criteria to be eligible for the study:
1. Have histologically confirmed HER2+ breast carcinoma, with HER2+ defined by fluorescence in situ hybridization (FISH) and/or 3+ staining by immunohistochemistry (IHC)
a. Tissue blocks or slides must be submitted to confirm HER2 positivity (FISHpositive or IHC 3+) by a sponsor-designated central laboratory prior to randomization. Centrally confirmed HER2 results (either IHC or FISH) from a previous study can be used to determine eligibility for this study with approval from the sponsor.
2. Have received previous treatment with a taxane, trastuzumab, pertuzumab, and T-DM1
3. Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
4. Have measurable or non-measureable disease assessable by RECIST 1.1
5. Be at least 18 years of age at time of consent
6. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
7. Have a life expectancy of at least 6 months, in the opinion of the investigator
8. Have adequate hepatic function as defined by the following:
a. Total bilirubin < or equal to 1.5 X upper limit of normal (ULN), except for patients with known Gilbert’s disease, who may enroll if the conjugated bilirubin is < or equal to 1.5 X ULN
b. Transaminases [aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT)] < or equal to 2.5 X ULN (< or equal to 5 X ULN if liver metastases arepresent)
9. Have adequate baseline hematological parameters as defined by:
a. Absolute neutrophil count (ANC) > or equal to 1.5 x 103/μL
b. Platelet count > or equal to 100 x 103/μL
c. Hemoglobin > or equal to 9 g/dL
10. Have creatinine clearance > or equal to 50 mL/min as calculated per institutional guidelines
11. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) < or equal to 1.5 X ULN unless on medication known to alter INR and aPTT. (Note: Warfarin and other coumarin derivatives are prohibited.)
12. Have left ventricular ejection fraction (LVEF) > or equal to 50% as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 4 weeks prior to first dose of study treatment
13. If female of childbearing potential, must have a negative result of serum pregnancy test performed within 7 days prior to first dose of study treatment. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
14. Women of childbearing potential (as defined above) and men with partners of childbearing potential must agree to use a highly effective birth control method, i.e. methods that achieve a failure rate of less than 1% per year when used consistently and correctly.
15. Patient must provide signed informed consent per a consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC) prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient’s disease.
16. Patients must be willing and able to comply with study procedures.
Applicable Disease SitesBreast - Female
Breast - Male
Therapies InvolvedChemotherapy multiple agents systemic
Immunotherapy
Drugs InvolvedHerceptin (Trastuzumab)
ONT-380
Placebo
Trastuzumab
Xeloda (capecitabine)
capecitabine
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02614794
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