Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2

Completed · Phase 1

Conditions studied: Breast Cancer, Metastatic Cancer

In brief

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib in treating patients with advanced or metastatic breast cancer that overexpresses HER2.

Key facts

Study ID

NCT00544804

Run by

University of California, San Francisco

People needed

41

Starts

2007-08-01

Expected to finish

2013-12-01

Last updated by the study team

2014-07-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status 0-2
• Life expectancy > 3 months
• Female
• Menopausal status not specified
• Absolute neutrophil count ≥ 1,000 cells/mm\^3
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 75,000 cells/mm\^3
• Total bilirubin normal
• AST and ALT ≤ 3 x upper limits of normal (ULN) (≤ 5 x ULN with liver metastases)
• Creatinine normal OR creatinine clearance ≥ 40 mL/min
• INR ≤ 1.5
• Potassium normal
• Magnesium normal
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception prior to and during study therapy
• Cardiac ejection fraction ≥ 50%
• Consents to 2 tumor fine needle aspiration biopsies for biomarker analysis
• Lung-only disease or sites otherwise deemed high-risk for biopsy, the requirement for biopsy will be waived

You may not qualify if…

• History of significant cardiac disease including any of the following:
• Congestive heart failure
• Symptomatic cardiac arrhythmias
• Unstable angina
• Uncontrolled prior lapatinib ditosylate therapy toxicity ≥ grade 2
• Allergic reactions to IV contrast dye despite standard prophylaxis
• History of malabsorption syndrome or disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism, or excretion of study drug
• Conditions that would impair the patient's ability to swallow and retain oral medication
• Concurrent disease or condition that would make the patient inappropriate for study participation or would interfere with the patient's safety
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
• PRIOR CONCURRENT THERAPY:
• Prior lapatinib ditosylate or trastuzumab allowed
• At least 4 weeks since prior and no concurrent chemotherapy or investigational anticancer agents
• At least 2 weeks since prior and no concurrent hormonal therapy
• At least 2 weeks since prior and no concurrent lapatinib ditosylate prohibited medications, including CYP3A4 inhibitors or inducers, all herbal supplements, and gastric pH modifiers
• More than 4 weeks since prior radiotherapy
• No aspirin or plavix therapy within 7 days prior to tumor biopsy
• No concurrent coumadin
• Low molecular weight heparin allowed provided it can be held at least 24 hours prior to tumor biopsy
• Concurrent gonadal suppression agents (i.e., Zoladex or Lupron) or palliative bisphosphonates (i.e., Zometa) allowed

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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