Breast CancerPhase 3NCT00424606
Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients
A Phase 3 study testing Docetaxel and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 12 sites in Greece.
Trial summary
The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. 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 and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 12 sitesGreece
- Study dates
- Jun 2001to Aug 2013
- 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
- Histologically or cytologically confirmed breast adenocarcinoma.
- Within 20-45 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
- Absence of lymph node involvement after eclosion and hormone (E\&H) staining and light microscopy evaluation.
- Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:
- Estrogen receptor (ER) (-) and progesterone receptor (PR)(-);
- Ki-67 + > 30%; Grade III; HER2 (3+) (after an amendment on 15.05.2008 women with HER2 (3+) were not included); Perineural infiltration or presence of tumor emboli in blood or lymph vessels.
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- Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of the above mentioned high risk criteria.
- Premenopausal and postmenopausal women with tumors measuring > 2 cm are eligible irrespectively of the expression of the above adverse prognostic tumor criteria.
- Absence of any clinical or radiological evidence of local or metastatic disease.
- Age > 18 years.
- Performance status (WHO) < 3.
- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9 gr/mm^3).
- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2 mg/dl).
- Adequate cardiac function (LVEF > 50%).
- Negative pregnancy test.
- Informed consent.
Who cannot join
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
- Other concurrent uncontrolled illness that could affect compliance with the study.
- Psychiatric illness or social situation that would preclude study compliance.
- Pregnant or nursing women.
- History of allergic reaction attributed to docetaxel.
- Other concurrent investigational agents.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Greece12 sites
University Hospital of Alexandroupolis Dept. of Medical Oncology
Alexandroupoli
"Agios Savvas" Anticancer Hospital of Athens
Athens
"IASO" General Hospital of Athens
Athens
"Laikon" General Hospital
Athens
"Marika Iliadis" Hospital of Athens
Athens
"Metaxa's" Anticancer Hospital of Pireas
Athens
401 Military Hospital of Athens
Athens
Air Forces Military Hospital of Athens
Athens
University Hospital of Heraklion
Heraklion, Crete, 71110
State General Hospital of Larissa
Larissa
"AXEPA" General Hospital of Thessaloniki
Thessaloniki
"Theagenion" Anticancer Hospital of Thessaloniki
Thessaloniki
About this study
Official title: A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients
The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Epirubicin
- Keywords
- High risk node negative
- 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 at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles
EpirubicinDrug
Also called Farmorubicin
Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles
EpirubicinDrug
Also called Farmorubicin
Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
DocetaxelDrug
Also called Taxotere
Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Docetaxel; Drug: Epirubicin |
| 2 | Experimental | Not described Receives: Drug: Epirubicin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free interval between the two treatment arms
Measured: Five years
Secondary outcomes (1)
Comparison of overall survival and safety between the two treatment arms
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startJun 2001
- Primary completionAug 2013
- Study completionAug 2013
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
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Oncology Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Crete
- Responsible party
- Sponsor
- Investigators
- Dimitris Mavrudis, MD, Principal investigator, University Hospital of Heraklion Dept. of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424606
- Sponsor's protocol ID
- CT/01.04
- Status last verified
- May 2015
- First submitted
- 18 Jan 2007
- Last updated
- 20 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase III Study of Adjuvant Treatment With Epirubicin Followed by Docetaxel (E/T) Versus Epirubicin and Docetaxel Combination (ET) in High Risk Lymph Node Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00424606
- Acronym / sponsor ID
- CT/01.04
- Conditions
- Breast Cancer
- Keywords
- High risk node negative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- Jun 2001
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Jan 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.
The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.
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 |
| 2 | Experimental | Drug: Epirubicin, Drug: Docetaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed breast adenocarcinoma.
- Within 20-45 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
- Absence of lymph node involvement after eclosion and hormone (E\&H) staining and light microscopy evaluation.
- Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:
- Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of the above mentioned high risk criteria.
Key exclusion criteria (6 listed)
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
- Other concurrent uncontrolled illness that could affect compliance with the study.
- Psychiatric illness or social situation that would preclude study compliance.
- Pregnant or nursing women.
- History of allergic reaction attributed to docetaxel.
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 at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles | Drug | 1 |
| EpirubicinAlso: FarmorubicinEpirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles | Drug | 1 |
| EpirubicinAlso: FarmorubicinEpirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles | Drug | 2 |
| DocetaxelAlso: TaxotereDocetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles | Drug | 2 |
Primary outcome
Disease-free interval between the two treatment arms
Time frame: Five years
1 secondary outcome
Comparison of overall survival and safety between the two treatment arms
Time frame: Five years
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 20 May 2015.
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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 Heraklion Dept. of Medical Oncology
12 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 and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 12 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 16 inclusion and 6 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Disease-free interval between the two treatment arms (time frame: Five 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 20 May 2015.