Clinical trial · Interventional
Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer
A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients With Treatment- Naive Breast Cancer
NCT00359190CI-TRIAL-00030287completedPhase 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)
This study will examine the inhibition of ErbB1 and ErbB2 phosphorylation and downstream mediators of tumor cell growth and survival tumor tissue in treatment-naive breast cancer patients for three dosing schedules of lapatinib.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lapatinib | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lapatinib receivers
- description
- Subjects with treatment-naïve breast tumors will be administered lapatinib 1500 mg once daily, 1000 mg once daily, or 500 mg twice daily for a minimum of 9 days and maximum of 15 days prior to surgical resection..
- interventionNames
- Drug: lapatinib
Primary outcomes (1)
- measure
- Comparison of the effects of 3 dosing schedules of lapatinib on biomarkers involved in regulating tumor cell proliferation and survival in pre-treatment and post-treatment breast tumor tissue samples.
- timeFrame
- subjects on study up to 15 days
- description
- biomarker analysis of tumor biopsies pre/post dose
Secondary outcomes (1)
- measure
- Evaluation of adverse events and changes in lab values from pre-dose and post-dose. Assessment of safety & tolerability of lapatinib at multiple doses when administered to patients who have not have not been treated for breast tumors.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Clinical labs are within acceptable ranges. * A histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied. * At least 18 years of age. * Females must meet certain criteria specified in protocol. * Ability to swallow and retain oral medication. * Ability to follow and understand directions. Exclusion criteria: * Female who is pregnant or lactating. * Medically unfit by the doctor as a result of the medical interview or physicals. * Received treatment of an investigational drug within 4 weeks of study start. * Currently receiving treatment with prohibited meds listed in protocol. * Had major surgery in previous 2 weeks. * Had prior radiation therapy to the chest to treat this incidence of breast cancer. * Hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med. * Has a malabsorption syndrome.
References
Publications (1)
- DERIVEDSpector NL, Robertson FC, Bacus S, Blackwell K, Smith DA, Glenn K, Cartee L, Harris J, Kimbrough CL, Gittelman M, Avisar E, Beitsch P, Koch KM. Lapatinib Plasma and Tumor Concentrations and Effects on HER Receptor Phosphorylation in Tumor. PLoS One. 2015 Nov 16;10(11):e0142845. doi: 10.1371/journal.pone.0142845. eCollection 2015. PMID 26571496