Breast CancerPhase 3NCT00429871
Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
A Phase 3 study testing Docetaxel, Capecitabine and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 10 sites in Greece.
Trial summary
The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Read more about this study
- Who is it for?
- Ages 19 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel, Capecitabine and Epirubicin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 10 sitesGreece
- Study dates
- May 2002to Nov 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 19 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma.
- No previous chemotherapy treatment for metastatic disease.
- No previous anthracycline treatment except as adjuvant therapy at least one year before.
- Age 19-75 years old
- Presence of measurable disease
- Performance status 0-2 (WHO)
Show all 10Show fewer
- Adequate cardiac function (LVEF >50%) without a recent (within 6 months) history of myocardial infraction and/or unstable or uncontrolled angina.
- Adequate bone marrow(absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3), liver (bilirubin <1.5 times upper limit of normal and SGOT/SGPT <2 times upper limit of normal) and renal function (creatinine <2mg/dl).
- No previous radiotherapy to more than 25% of marrow-containing bones.
- Written informed consent
Who cannot join
- Active brain metastases.
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except of nonmelanoma skin cancer.
- Positive pregnancy for premenopausal women.
- Concurrent antineoplastic treatment e.g. hormonal therapy
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 Heraklion
Heraklion, Crete, 71110
State General Hospital of Larissa, Dep of Medical Oncology
Larissa
"Metaxa's" Anticancer Hospital of Piraias
Piraeus
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki
About this study
Official title: A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer
The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline
Read the detailed description
This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as first line treatment in women with MBC
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Capecitabine, Epirubicin
- Keywords
- Metastatic breast cancer;, First line chemotherapy;, Docetaxel;, Epirubicin;, Capecitabine
- 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 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
CapecitabineDrug
Also called Xeloda
Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles
EpirubicinDrug
Also called Farmorubicin
Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
DocetaxelDrug
Also called Taxotere
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DF Receives: Drug: Docetaxel; Drug: Epirubicin |
| 2 | Experimental | DC Receives: Drug: Capecitabine; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the time to tumor progression between the two treatment arms
Measured: 1 year
Secondary outcomes (2)
Overall survival
Measured: 1 year
Toxicity profile between the two treatment arms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startMay 2002
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 272 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, Dep of Medical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429871
- Sponsor's protocol ID
- CT/02.09
- Status last verified
- May 2009
- First submitted
- 31 Jan 2007
- Last updated
- 29 May 2009
- Results posted
- No
Publications
Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PubMed 34037241
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00429871
- Acronym / sponsor ID
- CT/02.09
- Conditions
- Breast Cancer
- Keywords
- Metastatic breast cancer;, First line chemotherapy;, Docetaxel;, Epirubicin;, Capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Hellenic Oncology Research GroupUniversity, hospital or other
- Collaborators
- University Hospital of Crete
- Study start
- May 2002
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 1 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.
The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline
Detailed description
This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as first line treatment in women with MBC
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: EpirubicinDF |
| 2 | Experimental | Drug: Capecitabine, Drug: DocetaxelDC |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically- or cytologically- confirmed metastatic breast adenocarcinoma.
- No previous chemotherapy treatment for metastatic disease.
- No previous anthracycline treatment except as adjuvant therapy at least one year before.
- Age 19-75 years old
- Presence of measurable disease
Key exclusion criteria (6 listed)
- Active brain metastases.
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except of nonmelanoma skin cancer.
- Positive pregnancy for premenopausal women.
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 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles | Drug | 1 |
| CapecitabineAlso: XelodaCapecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles | Drug | 2 |
| EpirubicinAlso: FarmorubicinEpirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles | Drug | 1 |
| DocetaxelAlso: TaxotereDocetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles | Drug | 2 |
Primary outcome
Compare the time to tumor progression between the two treatment arms
Time frame: 1 year
2 secondary outcomes
Overall survival
Time frame: 1 year
Toxicity profile between the two treatment arms
Time frame: 1 year
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 29 May 2009.
- Derived from this study: PubMed 34037241Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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, Dep of Medical Oncology
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, Capecitabine 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 10 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 29 May 2009. 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?
Compare the time to tumor progression between the two treatment arms (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00429871, which also lists 1 linked publication.
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 29 May 2009.