Node Positive Breast CancerPhase 2NCT00189670
Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer
A Phase 2 study testing 6 TEC q 3 weeks, 4 EC q 2 weeks followed by 4 TXT q 2 weeks and 4 TXT q 2 weeks followed by 4 EC q 2 weeks in people with Node Positive Breast Cancer, run by Association Européenne de Recherche en Oncologie.
Trial summary
To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Node Positive Breast Cancer
- What is being tested?
- 6 TEC q 3 weeks, 4 EC q 2 weeks followed by 4 TXT q 2 weeks and 4 TXT q 2 weeks followed by 4 EC q 2 weeks
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 years and older
- Women only
- Adult, Older adult
Who may be able to join
- Patient with histologically proven breast cancer
- Surgical resection performed with clear margins (R0 resection)
- At least 1 histologically proven involved axillary node
- ER + or ER-
- Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days
- Aged over 18 years, and more than 10-year life expectancy
- ECOG performance status 0-1
- Signed informed consent form prior to randomization
Who cannot join
- Bilateral breast cancer
- Inflammatory breast cancer
- Personal history of breast cancer
- Immunohistochemical only node involvement
- Intraductal breast cancer
- Distant metastases
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- Contraindication to any drug contained in the chemotherapy regimens
- Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease
- Poor renal function (creatinin level > 120 micromol/L), poor hepatic function (total bilirubin level > 1 UNL), transaminases > 2.5 UNL)
- Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L; Hemoglobin < 10 G/dL
- Poor contractile cardiac function (LVEF < 50%)
- Coronary disease
- Any history of cancer during the last 5 years, with the exception of basal cell carcinomas or stage 0 (in situ) cervical carcinoma
- Pregnancy or breast feeding
- Absence of contraception in non menopausal women
- Adult patient unable to give informed consent because of intellectual impairment
- Concomitant participation to another trial
About this study
Official title: A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer
To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included.
- Conditions
- Node Positive Breast Cancer
- Being tested
- 6 TEC q 3 weeks, 4 EC q 2 weeks followed by 4 TXT q 2 weeks, 4 TXT q 2 weeks followed by 4 EC q 2 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 TEC q 3 weeksProcedure or surgery
4 EC q 2 weeks followed by 4 TXT q 2 weeksProcedure or surgery
4 TXT q 2 weeks followed by 4 EC q 2 weeksProcedure 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 Node Positive 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)
Sponsor and investigators
- Lead sponsor
- Association Européenne de Recherche en Oncologie
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Amgen
- Investigators
- Pascal Piedbois, MD, PhD, Principal investigator, Association Europeenne de Recherche en Oncologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189670
- Sponsor's protocol ID
- AERO-B03
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00189670
- Acronym / sponsor ID
- AERO-B03
- Conditions
- Node Positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Association Européenne de Recherche en OncologieUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Amgen
- 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 screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were 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
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with histologically proven breast cancer
- Surgical resection performed with clear margins (R0 resection)
- At least 1 histologically proven involved axillary node
- ER + or ER-
- Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days
Key exclusion criteria (17 listed)
- Bilateral breast cancer
- Inflammatory breast cancer
- Personal history of breast cancer
- Immunohistochemical only node involvement
- Intraductal breast cancer
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 |
|---|---|---|
| 6 TEC q 3 weeks | Procedure or surgery | – |
| 4 EC q 2 weeks followed by 4 TXT q 2 weeks | Procedure or surgery | – |
| 4 TXT q 2 weeks followed by 4 EC q 2 weeks | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
Pascal Piedbois, MD, PhD principal investigator
Association Europeenne de Recherche en Oncologie
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6 TEC q 3 weeks, 4 EC q 2 weeks followed by 4 TXT q 2 weeks and 4 TXT q 2 weeks followed by 4 EC q 2 weeks in people with Node Positive Breast Cancer, run by Association Européenne de Recherche en Oncologie.
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 17 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: finished, as of the sponsor's last update on 19 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Sep 2005.