Overview

This trial is active, not recruiting.

Condition neoplasms, breast
Treatments lapatinib, bevacizumab
Phase phase 2
Targets HER2, VEGF, AKT, CDK, EGFR, ERK
Sponsor GlaxoSmithKline
Start date February 2007
End date July 2008
Trial size 52 participants
Trial identifier NCT00444535, EGF103890

Summary

This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks)
lapatinib Tykerb/Tyverb
1500 mg oral lapatinib (once daily)
bevacizumab
10 mg/kg intravenous bevacizumab (every two weeks)

Primary Outcomes

Measure
Percentage of Participants Reaching Week 12 Without Disease Progression
time frame: Week 12

Secondary Outcomes

Measure
Overall Response
time frame: Week 6 through End of Study (until end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)
Clinical Benefit
time frame: Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)
Progression-free Survival
time frame: Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.