Clinical trial · Interventional
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer
NCT00075270CI-TRIAL-00017810completedPhase 3Results postedClinicalTrials.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 and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GW572016 (Lapatinib) | Drug | Lapatinib | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks
- interventionNames
- Drug: Paclitaxel
- Drug: GW572016 (Lapatinib)
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- description
- Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo
- interventionNames
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- Time to Progression as Evaluated by the Investigator
- timeFrame
- Randomization until the date of disease progression or death (average of 26 weeks)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Signed Informed Consent * Able to swallow an oral medication * Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram * Adequate kidney and liver function * Adequate bone marrow function * Tumor tissue available for testing * Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone * No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested Exclusion criteria: * Prior treatment regimens for advanced or metastatic breast cancer. * Pregnant or lactating * Conditions that would effect the absorption of an oral drug * Active infection * Brain metastases * Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor. * Known hypersensitivity to Taxol or excipients of Taxol * Peripheral neuropathy of Grade 2 or greater is not permitted * Severe Cardiovascular disease or cardiac disease requiring a device. * Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
References
Publications (3)
- BACKGROUNDTenori L, Oakman C, Claudino WM, Bernini P, Cappadona S, Nepi S, Biganzoli L, Arbushites MC, Luchinat C, Bertini I, Di Leo A. Exploration of serum metabolomic profiles and outcomes in women with metastatic breast cancer: a pilot study. Mol Oncol. 2012 Aug;6(4):437-44. doi: 10.1016/j.molonc.2012.05.003. Epub 2012 Jun 1. PMID 22687601
- BACKGROUNDFinn RS, Press MF, Dering J, Arbushites M, Koehler M, Oliva C, Williams LS, Di Leo A. Estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2 (HER2), and epidermal growth factor receptor expression and benefit from lapatinib in a randomized trial of paclitaxel with lapatinib or placebo as first-line treatment in HER2-negative or unknown metastatic breast cancer. J Clin Oncol. 2009 Aug 20;27(24):3908-15. doi: 10.1200/JCO.2008.18.1925. Epub 2009 Jul 20. PMID 19620495
- DERIVEDSherrill B, Di Leo A, Amonkar MM, Wu Y, Zvirbule Z, Aziz Z, Bines J, Gomez HL. Quality-of-life and quality-adjusted survival (Q-TWiST) in patients receiving lapatinib in combination with paclitaxel as first-line treatment for metastatic breast cancer. Curr Med Res Opin. 2010 Apr;26(4):767-75. doi: 10.1185/03007991003590860. PMID 20095796