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Title   E2108 Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Full Title   A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Description   This study is designed to compare the value of using surgery to treat early treatment of breast cancer tumors, which have already spread to other areas of the body, versus treatment with chemotherapy alone (the standard treatment for breast cancer that has spread to other areas). Patients will receive standard chemotherapy for a period of 4-5 months and then be randomly assigned to continue receiving chemotherapy or have their original breast cancer tumor removed by surgery then receive more chemotherapy post-operatively. Patients who have stable spread of disease (i.e. cancer that has not spread to any new places during the initial chemotherapy treatment time) will be considered eligible for this study.
Eligibility Criteria   1. Breast cancer, invasive type, which is unchanged and proven to be breast cancer by biopsy
2. At least 1 place in the body where the breast cancer has been shown to have spread to which is not near that of the original breast cancer tumor.
3. Chemotherapy not yet started, or started less than 16 weeks prior to joining the study
4. Central nervous system (CNS) metastases if projected survival > 6 months
5. Patients must be candidates for complete surgical removal of breast cancer followed by radiation therapy
6. Adequate organ function 2 weeks prior to random assignment to surgery or further treatment with chemotherapy.
Exclusion Criteria   1. No breast cancer found in the other breast at the same time of the first breast cancer being diagnosed.
2. Not pregnant or breast-feeding
3. No disease worsening after 4 months of initial chemotherapy regimen, demonstrable by CT scan documentation of disease status before treatment and within 2 weeks prior to study treatment assignment, including:
• No new site places that the cancer has spread to,
• No increase in tumor/malignancy size of more than or equal to 20% in longest measurement (to be measured by study staff and radiology)
• No ulceration or skin swelling at place where original breast cancer (to be treated) is located
Principal Investigator   Lisa Wiechmann, MD
Contact Name   Estella Forbes
Phone   (718) 862-8840
Contact Email   Estella Forbes
Post Date   11/22/2011
Protocol Number   2011-421
Inclusion/Notes   Interventional (Surgery/Chemotherapy)
Status   Active