An Open-label, Randomised, Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First or Second Line Treatment for Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer, or Loco-regional Recurrence Not Amenable to Treatment by Surgery or Radiotherapy.
- To compare the response rate in HER2-negative patients with locally advanced or
metastatic breast cancer or locoregional breast cancer recurrence treated with
docetaxel and a dietary phytochemical vs docetaxel alone.
- To compare the overall clinical benefit rate (i.e., objective response plus stable
disease) in patients treated with these regimens.
- To compare time to progression in patients treated with these regimens.
- To compare overall survival of patients treated with these regimens.
- To assess biomarkers of response in blood samples from patients treated with these
OUTLINE: This is a multicenter study. Patients are stratified according to recruitment
center and line of chemotherapy (first vs second line of docetaxel). Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3
weeks for up to 6 courses in the absence of disease progression or unacceptable
- Arm II: Patients receive docetaxel as in arm I. Patients also receive an oral dietary
phytochemical twice on day 1. Treatment repeats every 3 weeks for up to 6 courses in
the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Response rate as assessed by RECIST criteria
Philippe Chollet, MD, PhD
Centre Jean Perrin