Sequencing of Chemotherapy and Radiotherapy in Adjuvant Breast Cancer
- Compare the effects of synchronous vs sequential adjuvant chemotherapy and radiotherapy
on local recurrence, disease-free and overall survival, and treatment delay in women
with early-stage breast cancer.
- Compare the safety of these regimens, in terms of dose intensity and toxicity, in this
- Compare the quality of life and cosmetic outcome in patients treated with these
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
clinical oncologist, axillary clearance (yes vs no), radiotherapy boost intent (boost vs no
boost), and chemotherapy intent (cyclophosphamide, methotrexate, and fluorouracil [5-FU] vs
anthracycline-containing regimen). Patients are randomized to one of two treatment arms.
Patients receive any chemotherapy regimen that includes cyclophosphamide, methotrexate, and
5-FU. Some regimens may also include epirubicin, doxorubicin, mitoxantrone, and/or
mitomycin. Chemotherapy repeats every 3 weeks for 4-8 courses.
- Arm I (synchronous chemoradiotherapy): Patients receiving synchronous therapy receive
any of the above chemotherapy regimens plus daily radiotherapy between courses 2 and 3
OR courses 5 and 6 of chemotherapy. Radiotherapy is administered for 3-5 weeks.
- Arm II (sequential chemoradiotherapy): Patients receiving sequential therapy receive
any of the above chemotherapy regimens followed by daily radiotherapy beginning after
completion of all chemotherapy (after course 6 or 8). Radiotherapy is administered for
Treatment in both arms continues in the absence of disease progression or unacceptable
Quality of life is assessed before chemotherapy, 2-3 weeks after the completion of all
treatment, and then at 1, 2, and 5 years.
Patients are followed annually for 10 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 2,250 patients (1,125 per treatment arm) will be accrued for
Allocation: Randomized, Primary Purpose: Treatment
Indy Fernando, MD
University Hospital Birmingham
United States: Federal Government