Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Jacek Jassem, MD, PhD
Medical University of Gdansk
United States: Federal Government