Breast CancerPhase 2NCT00852332
Docetaxel With or Without a Phytochemical in Treating Patients With Breast Cancer
A Phase 2 study testing Curcumin and Taxotere in people with Breast Cancer, run by Centre Jean Perrin at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Curcumin and Taxotere
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Curcumin, Taxotere
- 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
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
TaxotereDrug
| Study group | Role | What they receive |
|---|---|---|
| Curcumine | Experimental | With curcumin capsules Receives: Dietary Supplement: Curcumin; Drug: Taxotere |
| Drug taxotere only | Active comparator | Without curcumin Receives: Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate as assessed by RECIST criteria
Measured: From the date of randomization until the end of the treatment, assessed up to 21 weeks
Secondary outcomes (4)
Overall clinical benefit rate as assessed by RECIST criteria
Measured: From the date of randomization until the end of the treatment, assessed up to 21 weeks
Time to progression as assessed by RECIST criteria
Measured: From date of randomization until the date of first documented progression or date of death from any cause, assessed up to 21 weeks
Overall survival as assessed by RECIST criteria
Evaluate overall survival (between inclusion and death whatever the cause)
Measured: From the date of randomization until the date of death from any cause
Safety as assessed by NCI CTCAE v3.0
Measured: From the date of randomization until the end of the treatment, assessed up to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: The trial was stopped for futility in view of the results of the anticipated analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Chollet, MD, PhD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852332
- Sponsor's protocol ID
- CDR0000635901
- Other IDs
- JEANP-CURRYTAX, INCA-RECF0908, EUDRACT-2008-003930-19
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2009
- Last updated
- 24 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00852332
- Acronym / sponsor ID
- CDR0000635901
- Conditions
- Breast Cancer
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was stopped for futility in view of the results of the anticipated analysis
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumine | Experimental | Dietary Supplement: Curcumin, Drug: TaxotereWith curcumin capsules |
| Drug taxotere only | Active comparator | Drug: TaxotereWithout curcumin |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin | Dietary supplement | Curcumine |
| Taxotere | Drug | Curcumine, Drug taxotere only |
Primary outcome
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
4 secondary outcomes
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
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
Overall survival as assessed by RECIST criteria
Time frame: From the date of randomization until the date of death from any cause
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
Results and safety
The study was stopped early (reason given: The trial was stopped for futility in view of the results of the anticipated analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Chollet, MD, PhD principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin and Taxotere in people with Breast Cancer, run by Centre Jean Perrin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was stopped for futility in view of the results of the anticipated analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.