Skip Navigation Links
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)
Overall Recruitment Status: Active, enrollment completed
 
Official Title
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)
 
Region Sponsors
California - Northern
Cascadian Therapeutics Inc
 
Acronym KP IRB No.
CN-16-2799
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
HER2 Positive Breast Cancer
 
Purpose
The 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.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • 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 (FISH-positive 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.
  • Have received previous treatment with a taxane, trastuzumab, pertuzumab, and T-DM1
  • 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
  • Have measurable or non-measureable disease assessable by RECIST 1.1
  • Be at least 18 years of age at time of consent
  • Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
  • Have a life expectancy of at least 6 months, in the opinion of the investigator
  • Have adequate hepatic function as defined by the following:
  • Total bilirubin =1.5 X upper limit of normal (ULN), except for patients with known Gilbert's disease, who may enroll if the conjugated bilirubin is =1.5 X ULN Transaminases [aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT)] = 2.5 X ULN (= 5 X ULN if liver metastases are present) Have adequate baseline hematological parameters as defined by:
  • Absolute neutrophil count (ANC) = 1.5 x 103/µL Platelet count = 100 x 103/µL Hemoglobin = 9 g/dL
  • Please contact research coordinator for more inclusion criteria
 
Exclusion Criteria
  • Have previously been treated with:
  • lapatinib within 12 months of starting study treatment or neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously. Have previously been treated with capecitabine for metastatic disease. Note: Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible.
  • History of exposure to the following cumulative doses of anthracyclines:
  • Doxorubicin > 360 mg/m2 Epirubicin > 720 mg/m2 Mitoxantrone > 120 mg/m2 Idarubicin > 90 mg/m2 Liposomal doxorubicin (e.g. Doxil, Caelyx, Myocet) > 550 mg/m2 Have history of allergic reactions to trastuzumab, capecitabine, or tucatinib (or compounds chemically or biologically similar), except for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed
  • Have received treatment with any systemic anti-cancer therapy (including hormonal therapy), non-CNS radiation, or experimental agent = 3 weeks of first dose of study 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
  • and congestive heart failure (CHF), which must have been = Grade 1 in severity at the time of occurrence, and must have resolved completely
  • Please contact study team for more exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • HER2 Positive Breast Cancer
  • HER
  • Oncology (Adult)
 
KP Clinical Facility
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Suga, MD
Contact Information:
- Desiree Goldstein
-Desiree.Goldstein@kp.org
-Vallejo Medical Center


smilelady1
Do you want to receive
Email Alerts?

Sign Up Here!





Regional Research Sites: