ARTemis - Avastin Randomized Trial With Neo-Adjuvant Chemotherapy for Patients With Early Breast Cancer
- To compare the efficacy of neoadjuvant therapy comprising docetaxel, fluorouracil,
epirubicin hydrochloride, and cyclophosphamide with versus without bevacizumab in
patients with HER2-negative nonmetastatic breast cancer.
- To assess quality of life of female patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 50 years
old vs > 50 years old), estrogen receptor status (negative [Allred score 0-2] vs weakly
positive [Allred score 3-5] vs strongly positive [Allred score 6-8]), total tumor size* (≤
50 mm vs > 50 mm), clinical involvement of axillary nodes (yes vs no), and
inflammatory/locally advanced disease (T4) (yes vs no). Patients are randomized to 1 of 2
NOTE: *In cases with multifocal disease in one breast, or bilateral disease, the size to be
used for the stratification is the sum of the single largest diameter of all measurable
- Arm I: Patients receive docetaxel IV on day 1; treatment repeats every 3 weeks for 3
courses. Patients then receive fluorouracil IV, epirubicin hydrochloride IV, and
cyclophosphamide IV on day 1 (FEC). Treatment with fluorouracil, epirubicin
hydrochloride, and cyclophosphamide repeats every 3 weeks for 3 courses.
- Arm II: Patients receive bevacizumab IV over 30 to 90 minutes and docetaxel IV on day
1; treatment repeats every 3 weeks for 3 courses. Patients then receive FEC as in arm
I. Treatment with FEC repeats every 3 weeks for 3 courses. Patients also receive
bevacizumab IV over 30 to 90 minutes and docetaxel IV on day 1 in FEC course 1 only.
Within 3-6 weeks after completion of last dose of study therapy, patients in both arms
undergo surgery. Within 4-8 weeks after surgery, patients undergo radiotherapy according to
Women complete quality-of-life questionnaires (FACT-B and EuroQoL) at baseline and during
and after completion of study treatment.
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for 3 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Complete pathological response rates (tumor and lymph nodes)
Helena Earl, MBBS, PhD, FRCP
Cambridge University Hospitals NHS Foundation Trust