Clinical trial · Interventional
Lapatinib in Treating Patients With Advanced or Metastatic Breast Cancer That Overexpresses HER2
A Phase I Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
NCT00544804CI-TRIAL-00014984completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| lapatinib ditosylate | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lapatinib
- description
- Dose Escalation Study of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
- interventionNames
- Drug: lapatinib ditosylate
- Genetic: gene expression analysis
- Other: diagnostic laboratory biomarker analysis
Primary outcomes (1)
- measure
- Maximum tolerated dose of Lapatinib
- timeFrame
- estimated to be 12 months
- description
- Dose Escalation of 5-Day Intermittent Oral Lapatinib Therapy With Biomarker Analysis in Patients With HER2-Overexpressing Breast Cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTChien AJ, Munster PN, Melisko ME, Rugo HS, Park JW, Goga A, Auerback G, Khanafshar E, Ordovas K, Koch KM, Moasser MM. Phase I dose-escalation study of 5-day intermittent oral lapatinib therapy in patients with human epidermal growth factor receptor 2-overexpressing breast cancer. J Clin Oncol. 2014 May 10;32(14):1472-9. doi: 10.1200/JCO.2013.52.1161. Epub 2014 Apr 7. PMID 24711549