Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
Recruitment status was Recruiting
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of breast cancer. It is not yet known whether giving docetaxel together with a phytochemical is more effective than giving docetaxel alone in treating patients with breast cancer.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with a phytochemical works compared with giving docetaxel alone as first- or second-line therapy in treating patients with breast cancer.
Dietary Supplement: phytochemical
Procedure: complementary or alternative medicine procedure
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Response rate as assessed by RECIST criteria [ Designated as safety issue: No ]
- Overall clinical benefit rate as assessed by RECIST criteria [ Designated as safety issue: No ]
- Time to progression as assessed by RECIST criteria [ Designated as safety issue: No ]
- Overall survival as assessed by RECIST criteria [ Designated as safety issue: No ]
- Safety as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
- 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 regimens.
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 toxicity.
- 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.
|Centre Jean Perrin||Recruiting|
|Clermont-Ferrand, France, 63011|
|Contact: Philippe Chollet, MD, PhD 33-4-7327-8198 firstname.lastname@example.org|
|Principal Investigator:||Philippe Chollet, MD, PhD||Centre Jean Perrin|