Breast CancerPhase 3NCT00431080
Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer
A Phase 3 study testing Docetaxel, Paclitaxel and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
Trial summary
Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel, Paclitaxel and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 10 sitesGreece
- Study dates
- Aug 2004to Oct 2007
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
- Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
- Tumor involvement of at least one axillary lymph node
- Absence of any clinical or radiological evidence of local or metastatic disease
- Premenopausal or postmenopausal women aged 18-75 years old
- Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
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- Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
- Adequate cardiac function (LVEF>50%)
- Written informed consent
Who cannot join
- Positive pregnancy test.
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
- Previous history of other invasive malignancy other than non-melanomatous skin cancer.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Greece10 sites
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
University Hospital of Crete
Heraklion, Crete, 71110
State General Hospital of Larissa, Dep of Medical Oncology
Larissa
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
Official title: A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer
Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer
Read the detailed description
This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Paclitaxel, Epirubicin, Cyclophosphamide, 5-fluoruracil
- Keywords
- Early breast cancer, Axillary node positive, Adjuvant chemotherapy, Dose dense, Docetaxel, Paclitaxel, FEC
- 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
Also called Taxotere
Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
PaclitaxelDrug
Also called Taxol
Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles
EpirubicinDrug
Also called Farmorubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
CyclophosphamideDrug
Also called Endoxan
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
5-fluoruracilDrug
Also called 5-FU
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
Granulocyte-colony stimulating growth factorDrug
Also called Granocyte, Neulasta
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FEC -> TXT Receives: Drug: Docetaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 5-fluoruracil; Drug: Granulocyte-colony stimulating growth factor |
| 2 | Experimental | FEC -> TXL Receives: Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 5-fluoruracil; Drug: Granulocyte-colony stimulating growth factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival
Measured: 3 years
Secondary outcomes (4)
Overall survival
Measured: 3 years
Recurrence rate
Measured: Relapses by the time of 3-years follow up
Τoxicity profile
Measured: Toxicity assessment on each chemotherapy cycle
Quality of life between the two treatment arms
Measured: Assessment every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startAug 2004
- Primary completionOct 2007
- Study completionOct 2007
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)
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Investigators
- Dimitris Mavrudis, MD, Principal investigator, University Hospital of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431080
- Sponsor's protocol ID
- CT/04.22
- Status last verified
- Jan 2008
- First submitted
- 2 Feb 2007
- Last updated
- 21 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00431080
- Acronym / sponsor ID
- CT/04.22
- Conditions
- Breast Cancer
- Keywords
- Early breast cancer, Axillary node positive, Adjuvant chemotherapy, Dose dense, Docetaxel, Paclitaxel, FEC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Aug 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 5 Feb 2007 (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.
Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer
Detailed description
This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: 5-fluoruracil, Drug: Granulocyte-colony stimulating growth factorFEC -> TXT |
| 2 | Experimental | Drug: Paclitaxel, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: 5-fluoruracil, Drug: Granulocyte-colony stimulating growth factorFEC -> TXL |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
- Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
- Tumor involvement of at least one axillary lymph node
- Absence of any clinical or radiological evidence of local or metastatic disease
- Premenopausal or postmenopausal women aged 18-75 years old
Key exclusion criteria (5 listed)
- Positive pregnancy test.
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
- Previous history of other invasive malignancy other than non-melanomatous skin 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 |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles | Drug | 1 |
| PaclitaxelAlso: TaxolPaclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles | Drug | 2 |
| EpirubicinAlso: FarmorubicinEpirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles | Drug | 1, 2 |
| CyclophosphamideAlso: EndoxanCyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks | Drug | 1, 2 |
| 5-fluoruracilAlso: 5-FU5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks | Drug | 1, 2 |
| Granulocyte-colony stimulating growth factorAlso: Granocyte, NeulastarhG-CSF 5 μg/kg/d on days 3-10 after each cycle | Drug | 1, 2 |
Primary outcome
3-year disease-free survival
Time frame: 3 years
4 secondary outcomes
Overall survival
Time frame: 3 years
Recurrence rate
Time frame: Relapses by the time of 3-years follow up
Τoxicity profile
Time frame: Toxicity assessment on each chemotherapy cycle
Quality of life between the two treatment arms
Time frame: Assessment every two cycles
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 21 Jan 2008.
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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.
Dimitris Mavrudis, MD principal investigator
University Hospital of Crete
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel, Paclitaxel and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
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 9 inclusion and 5 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 21 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Greece. 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?
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.
What does the primary outcome measure?
3-year disease-free survival (time frame: 3 years). 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 21 Jan 2008.