A Neoadjuvant Study of Chemotherapy Versus Endocrine Therapy in Postmenopausal Patients With Primary Breast Cancer
- To compare the efficacy and tolerability of cytotoxic chemotherapy versus aromatase
inhibition for the down-staging of strongly ER+ primary breast cancer in postmenopausal
- 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
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
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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Feasibility of patient recruitment (pilot)
R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci
Charing Cross Hospital