Clinical trial · Interventional
Lapatinib and Bevacizumab for Metastatic Breast Cancer
A Phase II, Open-Label Study of the Clinical Activity, Safety, and Tolerability of Lapatinib in Combination With Bevacizumab in Subjects With Advanced or Metastatic ErbB2-Overexpressing Breast Cancer
NCT00444535CI-TRIAL-00054636completedPhase 2Results 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)
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing 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 |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| lapatinib | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral lapatinib tablets in combination with IV bevacizumab
- description
- 1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks)
- interventionNames
- Drug: lapatinib
- Drug: bevacizumab
Primary outcomes (1)
- measure
- Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment
- timeFrame
- up to week 12
- description
- The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Since there is no independent reviewer, only the investigator response was reported.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Females that are at least 18 years of age. * Women of childbearing potential must have a negative serum pregnancy test at screening. * Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting. * Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic. * Adequate hepatic, renal and cardiac function * ECOG score 0-1 and a life expectancy of at least 12 weeks. * Able to swallow oral medication * Signed informed consent Exclusion criteria: * Pregnancy * Unstable or symptomatic CNS metastases * Major surgery within 28 days of enrollment (minor surgery within 7 days). * Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities. * A serious non-healing wound, ulcer, or bone fracture at baseline. * Class II, III or IV heart failure as defined by the NYHA functional classification system * History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension. * History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment. * History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment. * History of malabsorption syndrome, ulcerative colitis, or bowel obstruction. * Proteinuria * Requires concurrent anti-cancer treatment or investigational treatment. * Known hypersensitivity to either study medication * Received investigational treatment within 28 days or 5 half-lives, whichever is longer * Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study * Requires medication that has been excluded during study participation
References
Publications (1)
- BACKGROUNDRugo HS, Chien AJ, Franco SX, Stopeck AT, Glencer A, Lahiri S, Arbushites MC, Scott J, Park JW, Hudis C, Nulsen B, Dickler MN. A phase II study of lapatinib and bevacizumab as treatment for HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat. 2012 Jul;134(1):13-20. doi: 10.1007/s10549-011-1918-z. Epub 2011 Dec 24. PMID 22198412