Trial Information

Summary: Trialing Assigning Individualized Options for Treatment - The TAILORx Trial

The Dyson Center for Cancer Care at Vassar Brothers Medical Center in conjunction with the Cancer Trial Support Unit (CTSU) is conducting the TAILORx Trial.

The primary objective of this study is to determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal therapy in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall into the "primary study group" category (Oncotype DX Recurrence score 11-25). This study will utilize the Oncotype Dx Assay. Patients will not be responsible for any cost of the Oncotype Dx Assay that their insurance does not cover.

You may be eligible to participate in this trial if:

• Patient must be = 18 years of age and = 75 years of age.
• Diagnosed with adenocarcinoma of the female breast.
• Estrogen and/or progesterone positive.
• Negative axillary lymph nodes either by sentinel lymph node biopsy or complete axillary dissection.
• Tumor size 1.1 – 5.0 cm.
• Tumor must be Her2/neu negative.
• Patient and physician must be agreeable to initiate standard chemotherapy and hormonal therapy as adjuvant therapy.
• Tissue specimen from primary tumor must be obtainable.
• Meet laboratory criteria.
• Patients must be disease-free of prior invasive malignancies for = 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• Patients with a previous invasive breast cancer or bilateral synchronous cancers are not eligible.
• Entry onto study must be within 84 days from the final surgical procedure required to adequately treat the primary tumor.
• Surgical approach may have been a modified radical mastectomy or local excision plus an acceptable axillary procedure.
• No prior chemotherapy for this malignancy
• No prior radiation therapy for this malignancy
• Patients may have received up to 8 weeks of hormonal therapy for this malignancy and be eligible.
• Patient are not eligible if they were receiving hormonal therapy for breast cancer prevention and developed this malignancy while on therapy.
• Patients must have a life expectancy of at least 10 years.
• Patients with chronic obstructive pulmonary disease requiring treatment, chronic liver disease, previous history of cerebrovascular accident, history of congestive heart failure or other cardiac disease that would represent a contraindication to the use of an anthracycline are not eligible for this study.
• Patients with chronic psychiatric condition or other condition that would impair compliance with the treatment regimen are not eligible.
• Women must not be pregnant or breast feeding
• If the Oncotype Dx Assay has already been performed on the primary tumor, the Recurrence score must be between 11-25.

If you are interested in this study, please feel free to check with the Clinical Research Department at Vassar Brothers Medical Center for additional information.

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Trial listings updated: June 1, 2008 at 5:46:16 AM