Breast CancerPhase 3NCT00189631
UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
A Phase 3 study testing UFT/LV and Observation in people with Breast Cancer, run by Association Européenne de Recherche en Oncologie at 1 site in France.
Trial summary
To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- UFT/LV and Observation
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- metastatic breast cancer
- objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy
- time period between the end of chemotherapy and randomization < 4 weeks
- age over 18 years
- Performance status (OMS) < 2.
- Life expectancy > 3 months
- Biological criteria before randomization: Neutrophiles > 1.5 x 109 G/L; Pl. > 100 x 109 G/L; Hb > 10 g/dl; Creatininemia < 1,5 UNL; Bili. < 2 UNL; Transaminases < 2,5 UNL; Alcalines Phosphatases < 2,5 UNL
- Signed written informed consent
Who cannot join
- Metastatic breast cancer having received more than one chemotherapy line.
- Tumor progression under chemotherapy
- Free interval between primary tumor and metastases > 5 years, with estrogen receptors and without visceral metastases
- Free interval between primary tumor and metastases < 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization
- Concomitant hormonotherapy
- Other cancer
Show all 13Show fewer
- Symptomatic brain metastases
- Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF < 50% or coronary insufficiency
- Psychiatric disorder
- Other concomitant trial
- Male patient
- Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
- History of high dose chemotherapy with bone marrow transplantation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
AERO
Créteil, 94000
Laurent Zelek, MD, + 33 1 43 77 72 10, laurent.zelek@hmn.aphp.fr
About this study
To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.
- Conditions
- Breast Cancer
- Being tested
- UFT/LV, Observation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UFT/LVProcedure or surgery
ObservationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Association Européenne de Recherche en Oncologie
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Jean-Francois Berdah, MD, Principal investigator, AEROLaurent Zelek, MD, Principal investigator, AEROBruno Audhuy, MD, Principal investigator, AERO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189631
- Sponsor's protocol ID
- AERO-MB02
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 8 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
- ClinicalTrials.gov ID
- NCT00189631
- Acronym / sponsor ID
- AERO-MB02
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Association Européenne de Recherche en OncologieUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- First posted
- 19 Sep 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.
To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- metastatic breast cancer
- objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy
- time period between the end of chemotherapy and randomization < 4 weeks
- age over 18 years
- Performance status (OMS) < 2.
Key exclusion criteria (13 listed)
- Metastatic breast cancer having received more than one chemotherapy line.
- Tumor progression under chemotherapy
- Free interval between primary tumor and metastases > 5 years, with estrogen receptors and without visceral metastases
- Free interval between primary tumor and metastases < 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization
- Concomitant hormonotherapy
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 |
|---|---|---|
| UFT/LV | Procedure or surgery | – |
| Observation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2005.
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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.
Jean-Francois Berdah, MD principal investigator
AERO
Laurent Zelek, MD principal investigator
AERO
Bruno Audhuy, MD principal investigator
AERO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UFT/LV and Observation in people with Breast Cancer, run by Association Européenne de Recherche en Oncologie 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?
The sponsor lists 8 inclusion and 13 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 8 Dec 2005. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie Jouhaud (+ 33 1 43 77 72 10, annie.jouhaud@aero-eu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 8 Dec 2005.