Status:
COMPLETED
Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
HER2/Neu Positive
Recurrent Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best way of giving trastuzumab emtansine in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has sprea...
Detailed Description
PRIMARY OBJECTIVES: I. To assess change in thrombokinetics (platelet circulation life span). SECONDARY OBJECTIVES: I. Benefit rate (as defined by stable disease, partial response, or complete respo...
Eligibility Criteria
Inclusion
- Signed study-specific informed consent form
- Histologically or cytologically documented breast cancer
- Metastatic or unresectable locally advanced/recurrent breast cancer
- HER2-positive disease documented as in situ hybridization (ISH)-positive and/or 3+ by immunohistochemistry (IHC) on previously collected tumor tissue
- Absolute neutrophil count (ANC) \> 1500 cells/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 9.0 g/dL (patients are allowed to receive transfused red blood cells \[RBC\] to achieve this level)
- Total bilirubin =\< 1.5 × upper limit of normal (ULN), except in patients with previously documented Gilbert's syndrome, in which case the direct bilirubin should be less than or equal to the ULN
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 × ULN
- Alkaline phosphatase =\< 2.5 × ULN (patients with hepatic and/or bone metastases: alkaline phosphatase =\< 5 × ULN)
- Serum creatinine \< 1.5 × ULN
- International normalized ratio (INR) \< 1.5 × ULN
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Left ventricular ejection fraction (LVEF) \>= 50% by either echocardiogram (ECHO) or multigated acquisition scan (MUGA)
- Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women \< 12 months after entering menopause
- For women of childbearing potential and men with partners of childbearing potential, agreement by the patient and/or partner to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception; female patients of childbearing potential must agree to use two effective forms of non-hormonal contraception; effective methods of contraception include: intrauterine device (IUD); female condom; male condom; diaphragm with spermicide; cervical cap; or a sterile sexual partner; male patients with partners of childbearing potential must use barrier contraception; in addition, male patients should also have their partners use another method of contraception from the time of informed consent through the duration of study activity
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including thrombokinetic studies and platelet function studies
Exclusion
- CANCER-RELATED CRITERIA
- Known platelet disorder, such as von Willebrand's disease or baseline platelet count of \< 100,000/mm\^3
- Chemotherapy =\< 21 days before first study treatment
- Trastuzumab =\< 21 days before first study treatment
- Lapatinib =\< 14 days before first study treatment
- Investigational therapy or any other therapy =\< 28 days before first study treatment
- Any prior ado-trastuzumab emtansine
- Previous radiotherapy for the treatment of unresectable, locally advanced/recurrent or metastatic breast cancer is not allowed if:
- The last fraction of radiotherapy has been administered within 14 days of first on-study thormbokinetic study
- The patient has not recovered from any resulting acute toxicity (to grade =\< 1) prior to first on-study thormbokinetic study
- Brain metastases that are untreated or symptomatic, or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 14 days of first on-study thrombokinetic study; for patients with newly diagnosed brain metastases or unequivocal progression of brain metastases on screening scans, localized treatment (i.e., surgery, radiosurgery, and/or whole brain radiotherapy) is required before study enrollment; subjects with known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 14 days of stable neurologic function prior to the first thrombokinetic procedure; patients with small brain metastases not symptomatic and deemed requiring treatment by managing clinicians or study investigators may be permitted to enroll on study
- History of intolerance (including grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins
- Current peripheral neuropathy of grade \>= 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0
- Current use of any platelet functioning inhibitors (including aspirin) within 14 days of first on-study thrombokinetic study
- CARDIOPULMONARY FUNCTION CRITERIA
- Current unstable ventricular arrhythmia requiring treatment
- History of symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] classes II-IV)
- History of myocardial infarction or unstable angina within 6 months of enrollment
- History of a decrease in LVEF to \< 40% or symptomatic CHF with previous trastuzumab treatment
- Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
- GENERAL CRITERIA
- Current severe, uncontrolled non-cancer systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) resulting in a life expectancy of \< 6 months
- Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment
- Current pregnancy or lactation
- Current known active infection with human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C virus; for patients who are known carriers of hepatitis B virus (HBV), active hepatitis B infection must be ruled out based on negative serologic testing and/or determination of HBV deoxyribonucleic acid (DNA) viral load per local guidelines
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01816035
Start Date
June 1 2014
End Date
April 1 2017
Last Update
May 23 2017
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109