Her2 and Inflammatory BC trial

[Soccermom]

Dear Joe ,just received this information today via MDAnderson newsletter "CancerPro"...Thought you might want to approve it before posting?

Warmly,Marcia


Featured Clinical Trial
A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib versus Lapatinib Monotherapy in Patients with ErB2 Over-expressing Inflammatory Breast Cancer

• Inflammatory breast carcinoma (IBC) is an aggressive form of breast cancer accounting for 1to 3 percent of all invasive breast tumors in the United States. Although advances in aggressive multi-modality therapeutics have impacted survival in IBC, the prognosis remains poor with three year survival rates of 40 percent for IBC compared with 85 percent for non-inflammatory locally advanced breast cancer patients.
  
  The primary objective of this study is to compare the progression-free survival between pazopanib in combination with lapatinib versus lapatinib alone in patients with relapsed or refractory IBC whose tumors over-express ErbB2.
  
  “Patients with recurrent and refractory IBC have a poor prognosis and really don’t have any good therapeutic options,” says Dr. Cristofanilli, associate professor of medicine in the department of Breast Medical Oncology and Director of the Morgan Welch Inflammatory Breast Cancer Research Program and Clinic. “One of the most promising options appears to be treatment with lapatinib, which was approved in combination with capecitabine in March of 2007 for treatment of ErbB2 over-expressing breast cancer by the U.S. Food and Drug Administration.”
  
  To be eligible to participate in this study, patients must meet the following criteria:

Inclusion Criteria:

• Histological confirmation of breast carcinoma with a clinical diagnosis of IBC.
• Disease progression or relapse following treatment for IBC, which must have included a chemotherapy regimen.
• Tumor that over-expresses ErbB2 as defined by at least one of the following based on local results:
  1) 3+ over-expression by IHC
  2) HER2 gene amplification by FISH or CISH. Archived tumor tissue must be provided for all patients for ErbB2 FISH testing by the central laboratory.
• Radiographically measurable disease according to RECIST or evaluable IBC cutaneous disease. If the only evidence of recurrent IBC is cutaneous disease, the cutaneous disease must have been biopsied at some time.
• Radiographically measurable lesions may be in the field of prior adjuvant irradiation; however, there must be at least an eight-week period between the last radiation treatment and the baseline scan documenting disease status for the lesion to be measurable. If the irradiated lesion is the only site of disease, documented progression of the irradiated lesion is required.
• Adequate organ function as defined by lab values in the protocol. Patients may not have had a transfusion within seven days of screening assessment.
• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram.
• Archived tumor tissue must be provided for all patients.
• Eastern Cooperative Oncology Group (ECOG) performance status of < 2.
• A female is eligible to enter and participate in this study if she is of non-childbearing potential.

Exclusion Criteria:

• Treatment in the 14 days prior to randomization with any cancer therapy or treatment with mitomycin within six weeks prior to randomization.
• Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity.
• Prior lapatinib therapy.
• Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or five half-lives, whichever is longer, prior to the first dose of investigational product.
• Evidence of recurrence or active disease from prior malignancy.
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic.
• Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding.
• Any serious and/or unstable pre-existing medical, psychiatric or other condition that could interfere with patient’s safety, provision of informed consent or compliance to study procedures.
• Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or lapatinib.

For more information or to enroll a patient, please contact Cindy Lipsanen at 713-563-0707 or e-mail: <A href="mailto:clipsanen@mdanderson.org" __doClobber__="true">clipsanen@mdanderson.org.