Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-30 @ 1:30 PM
Study NCT ID:
NCT00852332
Status:
TERMINATED
Last Update Posted:
2018-07-24
First Post:
2009-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
Sponsor:
Centre Jean Perrin
Organization:
Study Overview
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.
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was stopped for futility in view of the results of the anticipated analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Primary
* 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.
Secondary
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: