Clinical trial · Interventional
Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens
NCT00051103CI-TRIAL-00017538completedPhase 2ClinicalTrials.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)
The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Neoplasms, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Investigational Cancer Drug | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.) * Signed informed consent * No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin. * Refractory Stage IIIb or IV breast cancer * HER2/neu tumor overexpression * Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy. * Tumor tissue available for testing. * 2 weeks since treatment with Herceptin (alone or in combination). * Able to swallow and retain oral medication * Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan). * Adequate kidney and liver function * Adequate bone marrow function Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.) * Prior regimens did not include Herceptin. * Pregnant or lactating. * Conditions that would affect absorption of an oral drug * Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent. * Severe cardiovascular disease or cardiac disease requiring a device. * Active infection. * Brain metastases. * Concurrent cancer therapy or investigational therapy. * Use of oral or IV steroids. * Unresolved or unstable serious toxicity from prior therapy. * Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.
References
Publications (1)
- BACKGROUNDBlackwell KL, Pegram MD, Tan-Chiu E, Schwartzberg LS, Arbushites MC, Maltzman JD, Forster JK, Rubin SD, Stein SH, Burstein HJ. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol. 2009 Jun;20(6):1026-31. doi: 10.1093/annonc/mdn759. Epub 2009 Jan 29. PMID 19179558