Description:
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.
Title
- Brief Title: Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
- 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.
Clinical Trial IDs
- ORG STUDY ID:
CDR0000635901
- SECONDARY ID:
JEANP-CURRYTAX
- SECONDARY ID:
INCA-RECF0908
- SECONDARY ID:
EUDRACT-2008-003930-19
- NCT ID:
NCT00852332
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Taxotere | | Curcumine |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Curcumine | Experimental | With curcumin capsules | |
| Drug taxotere only | Active Comparator | Without curcumin | |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the breast, meeting 1 of
the following criteria:
- Locally advanced disease
- Documented metastatic disease without overexpression of Her2/neu
- Must have received prior anthracycline-containing regimen as neoadjuvant,
adjuvant, or first-line chemotherapy for metastatic breast cancer
- Loco-regional recurrence not amenable to treatment by surgery or radiotherapy
- At least one measurable lesion according to RECIST criteria
- No bone lesion only disease
- Must be a candidate for taxane-based chemotherapy
- HER2-negative disease
- No symptomatic brain metastases
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- WHO performance status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- Serum creatinine < 140 µmol/L OR creatinine clearance > 60 mL/min
- Total bilirubin ≤ upper limit of normal (ULN)
- AST and ALT ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of significant neurologic (i.e., peripheral neuropathy ≥ grade 2) or
psychiatric disorders, including psychotic disorders, dementia, or seizures that would
prohibit the understanding, observance, and giving of informed consent
- No other prior or concomitant malignancies except adequately treated carcinoma in situ
of the cervix uteri, basal cell or squamous cell carcinoma of the skin, or other
cancer curatively treated with surgery and/or radiotherapy
- No concurrent severe and/or uncontrolled co-morbid medical condition
- No medically unstable patients
- No uncontrolled infection
- No autoimmune disease and/or chronic active inflammation
- No psychological, familial, social, or geographical reasons that would make clinical
follow-up impossible
- No malabsorption syndrome or disease significantly affecting gastrointestinal function
- No dysphagia ≥ grade 2
- No history of hypersensitivity to taxanes or known excipients, including polysorbate
80
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior major resection of the stomach or proximal small bowel
- Prior hormonal therapy as adjuvant treatment and/or treatment of metastatic disease
allowed provided that the patient has progressive disease at study entry
- Hormonal treatment must be discontinued prior to study entry
- No more than 1 prior chemotherapy regimen for metastatic disease
- More than 30 days since prior investigational drug
- More than 3 weeks since prior NSAIDs or COX_2 inhibitors
- No other concurrent anticancer therapy
- No other concurrent dietary phytonutrients
| Maximum Eligible Age: | 120 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Response rate as assessed by RECIST criteria |
| Time Frame: | From the date of randomization until the end of the treatment, assessed up to 21 weeks |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Overall clinical benefit rate as assessed by RECIST criteria |
| Time Frame: | From the date of randomization until the end of the treatment, assessed up to 21 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Time to progression as assessed by RECIST criteria |
| Time Frame: | From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 21 weeks |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival as assessed by RECIST criteria |
| Time Frame: | From the date of randomization until the date of death from any cause |
| Safety Issue: | |
| Description: | Evaluate overall survival (between inclusion and death whatever the cause) |
| Measure: | Safety as assessed by NCI CTCAE v3.0 |
| Time Frame: | From the date of randomization until the end of the treatment, assessed up to 21 weeks |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | Centre Jean Perrin |
Trial Keywords
- male breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- recurrent breast cancer
- stage IIIA breast cancer
- HER2-negative breast cancer
Last Updated
July 24, 2018
