Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
European Organisation for Research and Treatment of Cancer - EORTC
With
OBJECTIVES: * Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo mastectomy followed by radiotherapy. * Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options: * Regimen A: Patients receive radiotherapy alone. * Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone. * Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone. Patients with a CR to radiotherapy receive no further treatment. Patients with a PR to radiotherapy undergo limited surgery. Quality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Patients are followed within 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study within 5 years.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
