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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lapatinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Advanced or metastatic disease

• No effective curative therapy available

• Bone-only disease allowed

• Tumor HER2 overexpression

• HER2 3+ expression by immunohistochemistry OR > 2-fold (HER2 2+) gene amplification by fluorescence in situ hybridization

• Evaluable disease

• Measurable disease is not required

• No progressive brain metastases

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Inclusion criteria:

• 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

Exclusion criteria:

• 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