Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: Curcumin; Drug: Taxotere

• Registration Number: NCT00852332
• Lead Sponsor: Centre Jean Perrin

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.

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.

Study Timeline

• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Study Start: 2009-08
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumine	Curcumin	With curcumin capsules
Curcumine	Taxotere	With curcumin capsules
Drug taxotere only	Taxotere	Without curcumin

Primary Outcome Measures

Name	Time	Method
Response rate as assessed by RECIST criteria	From the date of randomization until the end of the treatment, assessed up to 21 weeks

Secondary Outcome Measures

Name	Time	Method
Overall survival as assessed by RECIST criteria	From the date of randomization until the date of death from any cause	Evaluate overall survival (between inclusion and death whatever the cause)
Time to progression as assessed by RECIST criteria	From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 21 weeks
Safety as assessed by NCI CTCAE v3.0	From the date of randomization until the end of the treatment, assessed up to 21 weeks
Overall clinical benefit rate as assessed by RECIST criteria	From the date of randomization until the end of the treatment, assessed up to 21 weeks

Trial Locations

Locations (1)

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France