Breast CancerPhase 2NCT00104624
Docetaxel in Treating Older Women With Metastatic Breast Cancer
A Phase 2 study testing docetaxel and quality-of-life assessment in people with Breast Cancer, run by UNICANCER at 7 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 7 sitesin 3 countries
- Study dates
- May 2005to Jul 2008
- 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Metastatic disease
- Measurable disease by CT scan or MRI
- Requires first-line chemotherapy for metastatic disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 70 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- Meets both of the following criteria:
- Lawton's Instrumental Activities of Daily Living score ≥ 4
- Katz's Activities of Daily Living score ≥ 4
Life expectancy
- More than 3 months
Hematopoietic
- Hemoglobin > 10 g/dL
- Neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- ALT and AST < 1.5 times normal
- Bilirubin normal
- Alkaline phosphatase < 2.5 times normal
Renal
- Creatinine clearance > 30 mL/min
Cardiovascular
- No congestive heart failure
- No unstable angina pectoris
- No myocardial infarction within the past year
- No uncontrolled hypertension
- No high-risk uncontrolled arrhythmias
Other
- Geriatric Depression Score < 12
- No active uncontrolled infection
- No active peptic ulcer
- No uncontrolled diabetes mellitus
- No inflammatory bowel disease
- No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80
- No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
- No familial, social, geographical, or psychological condition that would preclude study follow-up
- No definite contraindication to corticosteroids
- No other serious illness or medical condition
- No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior or concurrent trastuzumab (Herceptin^®)
Chemotherapy
- Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed
- More than 2 years since prior docetaxel or paclitaxel
- No other concurrent chemotherapy
Endocrine therapy
- No more than 1 prior hormonal therapy regimen for metastatic disease
- At least 10 days since prior hormonal therapy
- No concurrent hormonal therapy
- No concurrent chronic corticosteroids
- Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 30 days since prior active treatment on another clinical trial
- Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia
- No other concurrent anticancer therapy
- No other concurrent investigational drugs
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
France5 sites
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
Institut Curie Hopital
Paris, 75248
Centre Henri Becquerel
Rouen, 76038
C.H. Senlis
Senlis, 60309
Institut Gustave Roussy
Villejuif, F-94805
About this study
Official title: Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70
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.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.
Read the detailed description
OBJECTIVES:
Primary
- Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine overall and progression-free survival of patients treated with this drug.
- Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.
- Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.
- Determine toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses.
Ability to perform daily activities is assessed periodically.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- docetaxel, quality-of-life assessment
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months
Secondary outcomes (6)
Response rate
Overall survival
Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
Progression-free survival
Mood status as measured by the Geriatric Depression Scale
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2005 (estimated)
- Study startMay 2005
- Primary completionJul 2007
- Study completionJul 2008
Why it stopped: Toxicity issues
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.
- More trials run by UNICANCERThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzette Delaloge, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104624
- Sponsor's protocol ID
- CDR0000417747
- Other IDs
- FRE-FNCLCC-GERICO-04/0406, EU-20504
- Status last verified
- Sep 2013
- First submitted
- 3 Mar 2005
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70
- ClinicalTrials.gov ID
- NCT00104624
- Acronym / sponsor ID
- CDR0000417747
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Toxicity issues
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 4 Mar 2005 (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.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.
Detailed description
OBJECTIVES:
Primary
- Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine overall and progression-free survival of patients treated with this drug.
- Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.
- Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.
- Determine toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses.
Ability to perform daily activities is assessed periodically.
PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| docetaxel | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months
6 secondary outcomes
Response rate
Overall survival
Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
Progression-free survival
Mood status as measured by the Geriatric Depression Scale
Toxicity
Results and safety
The study was stopped early (reason given: Toxicity issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
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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.
Suzette Delaloge study chair
Gustave Roussy, Cancer Campus, Grand Paris
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and quality-of-life assessment in people with Breast Cancer, run by UNICANCER at 7 sites in 3 countries.
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 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Italy, Switzerland. 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: Toxicity issues). 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?
Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months. 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 4 Sep 2013.