Trial of Accelerated Adjuvant Chemotherapy With Capecitabine in Early Breast Cancer (TACT2)
- Compare the disease-free survival (DFS) of patients with completely resected early
stage breast cancer receiving 1 of 2 different schedules of adjuvant chemotherapy
comprising epirubicin, cyclophosphamide, methotrexate, and fluorouracil versus 1 of 2
different schedules of adjuvant chemotherapy comprising epirubicin and capecitabine.
- Compare overall survival (OS) and distant disease-free survival (DFS).
- Compare the tolerability (including serious adverse events [SAE], dose-intensity, and
toxicity) of these regimens.
- Determine the detailed toxicity of these regimens.
- Determine the quality of life of a subset of these patients.
OUTLINE: This is a multi-center, randomized study. Patients are stratified according to
participating center, nodal status (N0 vs N1-3 vs N≥ 4), age (≤ 50 years vs > 50 years), and
estrogen receptor (ER) status (negative vs positive). Patients are randomized to 1 of 4
- Arm I: Patients receive epirubicin on day 1. Treatment repeats every 3 weeks for 4
courses. Patients then receive cyclophosphamide orally once daily on days 1-14 or IV on
days 1 and 8 and methotrexate and fluorouracil on days 1 and 8. Treatment repeats every
28 days for 4 courses.
- Arm II: Patients receive epirubicin on day 1 and pegfilgrastim on day 2. Treatment
repeats every 2 weeks for 4 courses. Patients then receive cyclophosphamide,
methotrexate and fluorouracil as in arm I.
- Arm III: Patients receive epirubicin as in arm I. Patients then receive oral
capecitabine twice daily on days 1-14. Treatment with capecitabine repeats every 3
weeks for 4 courses.
- Arm IV: Patients receive epirubicin and pegfilgrastim as in arm II. Patients then
receive capecitabine as in arm III.
In all arms, treatment continues in the absence of unacceptable toxicity.
Beginning 3-6 months later, all patients may undergo radiotherapy at the discretion of the
principal investigator. Patients with ER- and/or progesterone receptor-positive disease then
receive tamoxifen citrate or an aromatase inhibitor for up to 5 years.
Quality of life is assessed in a cohort of 1,000 patients in week 6, week 8 or 12, and week
20 or 24 during treatment and then at 12 and 24 months after randomization.
After completion of study therapy, patients are followed every 6 months for 2 years and then
annually for at least 10 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 4,400 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Disease-free survival (DFS) at 5 years
David Cameron, MD
National Cancer Research Network
United States: Federal Government