Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Imperial College London
OBJECTIVES: * To compare the efficacy and tolerability of cytotoxic chemotherapy versus aromatase inhibition for the down-staging of strongly ER+ primary breast cancer in postmenopausal women. * To identify biological predictors of response to these two treatment modalities. OUTLINE: This is a multicenter pilot, feasibility study followed by a randomized study. In the pilot study, a record of all patients screened and invited to participate in the study is compiled. Reasons for failure to recruit will be recorded. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who do not achieve at least partial response after 3 courses receive docetaxel IV on day 1 of 3-week courses for an additional 3 courses. * Arm II: Patients receive oral letrozole daily for 18-23 weeks until day of surgery. Patients in both arms undergo surgery at week 18-23. Most patients then receive adjuvant therapy. Quality of life is assessed at baseline, periodically during study treatment, and then during follow up. Blood is collected pre-treatment, at mid-treatment, and before surgery. Blood is then collected every 6 months for 2 years. Blood samples and preserved tumor samples are used for correlative studies. After completion of surgery, patients are followed up at least annually for 10 years. PROJECTED ACCRUAL: A total of 40 patients for the pilot study and 716 patients for the phase III study will be accrued.
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
