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A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
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
Seagen Inc.
Cascadian Therapeutics Inc
 
Acronym KP IRB No.
HER2CLIMB CN-16-2799
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
(Adult, Older Adult) with histologically confirmed 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
This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.
 
Gender Age Limit
Male & Female 18 years & older
 
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
  • 2015-002801-12
  • HER
  • Antimetabolites
  • HER2 Positive Breast Cancer
  • Antimetabolites, Antineoplastic
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents
  • Neoplasms
  • Antineoplastic Agents, Immunological
  • Neoplasms by Site
  • Breast Cancer
  • ONT-380-206
  • Breast Diseases
  • Skin Diseases
  • Breast Neoplasms
  • Trastuzumab
  • Capecitabine
  • Oncology (Adult)
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Teresa Medical Center-San Jose
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


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


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