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Spots Global Cancer Trial Database for PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer

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Trial Identification

Brief Title: PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer

Official Title: A Phase I/II Study of PTK787 in Combination With Trastuzumab in Patients With Newly Diagnosed HER2 Overexpressing Locally Recurrent or Metastatic Breast Cancer: Hoosier Oncology Group Trial BRE04-80

Study ID: NCT00216047

Conditions

Breast Cancer

Interventions

PTK787
Trastuzumab

Study Description

Brief Summary: HER2 gene amplification increases VEGF production in breast cancers; combined inhibition of HER2 and VEGF enhances response in xenograft models. The upregulation of VEGF in HER2-overexpressing breast cancers may contribute to the aggressive phenotype observed in HER2-positive breast cancer. New therapeutics targeting VEGF and/or its receptors may enhance the efficacy of trastuzumab monotherapy. This trial will investigate the safety and efficacy of combined HER2 and VEGF inhibition.

Detailed Description: OUTLINE: This is a multi-center study. PTK787 daily plus trastuzumab 4 mg/kg IV week 1, followed by 2 mg/kg weekly with disease evaluation every other cycle. Patients may continue treatment until disease progression or toxicity intervenes. Performance Status: ECOG 0 or 1 Life Expectancy: Not specified Hematopoietic: * ANC \> 1500 mm3 * Platelets \> 100,000 mm3 * Hemoglobin \> 9 g/dL * PTT and INR \< 1.5 x ULN Hepatic: * ALT and AST \< 3 x ULN (\< 5 x ULN in patients with known liver metastases) * Alkaline phosphatase \< 2.5 x ULN * Serum bilirubin \< 1.5 x ULN Renal: * Serum creatinine \< 1.5 x ULN * Proteinuria \< 1+ by dipstick OR total urinary protein \< 500 mg/24 hours with measured creatinine clearance (CrCl) ≥ 50 mL/min Cardiovascular: * No clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months. * LVEF \> LLN by MUGA or ECHO (obtained within 28 days prior to being registered for protocol therapy) Pulmonary: * Not specified

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Elkhart Clinic, Elkhart, Indiana, United States

Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana, United States

Center for Cancer Care at Goshen Health System, Goshen, Indiana, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

Arnett Cancer Care, Lafayette, Indiana, United States

Medical Consultants, P.C., Muncie, Indiana, United States

Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States

AP&S Clinic, Terre Haute, Indiana, United States

Contact Details

Name: Kathy Miller, M.D.

Affiliation: Hoosier Oncology Group, LLC

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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