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Lapatinib and Bevacizumab for Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444535
First Posted: March 8, 2007
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.

Condition Intervention Phase
Neoplasms, Breast Drug: lapatinib Drug: bevacizumab Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Percentage of Participants Reaching Week 12 Without Disease Progression [ Time Frame: Week 12 ]
    The progression-free survival rate was evaluated by the investigator after 12 weeks of treatment and was defined as the number of participants with no evidence of disease progression (20% increase in sum of longest diameters, new lesions, or symptomatic progression) per Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause for a minimum of 84 days (12 weeks).


Secondary Outcome Measures:
  • 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) ]
    The percentage of participants with measurable disease with a best response of partial response (PR, 30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) or complete response (CR, complete resolution of lesions observed at baseline) per RECIST was measured. The first assessment of overall response was at Week6; however, the participants were assessed for response until treatment ended.

  • 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) ]
    Clinical benefit is defined as defined as the percentage of participants with evidence of a confirmed CR (complete resolution of lesions observed at baseline) or PR (30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) at any time or stable disease (insufficient response to qualify for CR or PR, and insufficient increase in tumor burden to qualify for progressive disease [20% increase in sum of longest diameters, new lesions, or symptomatic progression]) for at least 24 weeks per RECIST.

  • 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) ]
    Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.


Enrollment: 50
Actual Study Start Date: February 27, 2007
Estimated Study Completion Date: December 31, 2018
Primary Completion Date: July 22, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral lapatinib tablets in combination with IV bevacizumab
1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks)
Drug: lapatinib
1500 mg oral lapatinib (once daily)
Other Name: Tykerb/Tyverb
Drug: bevacizumab
10 mg/kg intravenous bevacizumab (every two weeks)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444535


Locations
United States, Arizona
Novartis Investigative Site
Tucson, Arizona, United States, 85724
United States, California
Novartis Investigative Site
San Francisco, California, United States, 94115
United States, Florida
Novartis Investigative Site
Hollywood, Florida, United States, 33021
Novartis Investigative Site
Tampa, Florida, United States, 33612
United States, New York
Novartis Investigative Site
Basking Ridge, New York, United States, 07920
Novartis Investigative Site
Commack, New York, United States, 11725
Novartis Investigative Site
New York, New York, United States, 10065
Novartis Investigative Site
Rockville Centre, New York, United States, 11570
Novartis Investigative Site
Sleepy Hollow, New York, United States, 10591
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00444535     History of Changes
Other Study ID Numbers: EGF103890
First Submitted: March 6, 2007
First Posted: March 8, 2007
Results First Submitted: July 9, 2009
Results First Posted: August 20, 2009
Last Update Posted: July 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
VEGF
Tyrosine kinase
ErbB2
Her2-neu
metastatic breast cancer
EGFR
ErbB1
bevacizumab
lapatinib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Lapatinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action