Breast CancerPhase 3NCT00002953
Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer
A Phase 3 study testing cyclophosphamide, epirubicin hydrochloride and paclitaxel in people with Breast Cancer, run by Medical Research Council at 19 sites in 2 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cyclophosphamide, epirubicin hydrochloride and paclitaxel
- How many people
- 704 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Dec 1996to Nov 2005
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven carcinoma of the breast with metastases No CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Not specified Menopausal status: Not specified Sex: Female Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (no greater than 5 times ULN with liver metastases) Renal: Not specified Cardiovascular: Ejection fraction within normal range No history of cardiac disease including myocardial infarction, cardiac failure and angina Other: Not pregnant No prior or concurrent malignancy that is likely to interfere with protocol treatments or comparisons
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy other than adjuvant No prior high dose adjuvant chemotherapy requiring transplantation Cumulative dose of doxorubicin no greater than 300 mg/m2 permitted Cumulative dose of epirubicin no greater than 400 mg/m2 permitted At least 6 months since prior anthracyclines Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United Kingdom18 sites
University Birmingham
Birmingham, England, B15 2TT
Bristol Royal Hospital for Sick Children
Bristol, England, BS2 8BJ
Bristol Oncology Centre
Bristol, England, BS2 8ED
Derbyshire Royal Infirmary
Derby, England, DE1 2QY
Royal Hospital for Sick Children
Edinburgh, Scotland
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
Cookridge Hospital
Leeds, England, LS16 6QB
University Hospitals of Leicester
Leicester, England, LE1 5WW
Middlesex Hospital- Meyerstein Institute
London, England, W1N 8AA
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Mount Vernon Hospital
Northwood, England, HA6 2RN
Norfolk & Norwich Hospital
Norwich, England, NR1 3SR
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Oxford Radcliffe Hospital
Oxford, England, 0X3 7LJ
Royal Preston Hospital
Preston, PR2 9HT
Royal Marsden Hospital
Sutton, England, SM2 5PT
Southend General Hospital
Westcliff-on-Sea, England
About this study
Official title: A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Compare the activity and toxicity of epirubicin and cyclophosphamide with that of epirubicin and paclitaxel in patients with metastatic breast cancer.
OUTLINE: Patients are randomized to receive either epirubicin and cyclophosphamide or epirubicin and paclitaxel. Each drug combination is given every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- cyclophosphamide, epirubicin hydrochloride, paclitaxel
- Keywords
- stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
epirubicin hydrochlorideDrug
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2004 (estimated)
- Study startDec 1996
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Enrolment
- 704 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- James Carmichael, MD, PhD, Study chair, Nottingham City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002953
- Sponsor's protocol ID
- CDR0000065426
- Other IDs
- MRC-UKCCCR-AB01, EU-97002
- Status last verified
- Dec 2005
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
Langley RE, Carmichael J, Jones AL, Cameron DA, Qian W, Uscinska B, Howell A, Parmar M. Phase III trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer: United Kingdom National Cancer Research Institute trial AB01. J Clin Oncol. 2005 Nov 20;23(33):8322-30. doi: 10.1200/JCO.2005.01.1817.
PubMed 16293863Carmichael J: UKCCCR trial of epirubicin and cyclophosphamide (EC) vs. epirubicin and taxol (ET) in the first line treatment of women with metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-84, 2001.
Carmichael J: UKCCCR trial of epirubucin and cyclophosphamide (EC) versus epirubicin and taxol (ET) in the first line treatment of women with metastatic breast cancer (MBC). [Abstract] Br J Cancer 85 (suppl 1): A-CT6, 2, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Radomized Trial of Epirubicin & Cyclophosphamide vs. Epirubicin & Paclitaxel in the Treatment of Women With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00002953
- Acronym / sponsor ID
- CDR0000065426
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 704 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Dec 1996
- Study completion
- Nov 2005 (actual)
- First posted
- 7 Jul 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.
Detailed description
OBJECTIVES: I. Compare the activity and toxicity of epirubicin and cyclophosphamide with that of epirubicin and paclitaxel in patients with metastatic breast cancer.
OUTLINE: Patients are randomized to receive either epirubicin and cyclophosphamide or epirubicin and paclitaxel. Each drug combination is given every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| epirubicin hydrochloride | Drug | – |
| paclitaxel | Drug | – |
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 4 Dec 2013.
- Results publication: PubMed 16293863Langley RE, Carmichael J, Jones AL, Cameron DA, Qian W, Uscinska B, Howell A, Parmar M. Phase III trial of epirubicin plus paclitaxel compared with epirubicin plus cyclophosphamide as first-line chemotherapy for metastatic breast cancer: United Kingdom National Cancer Research Institute trial AB01. J Clin Oncol. 2005 Nov 20;23(33):8322-30. doi: 10.1200/JCO.2005.01.1817.
- Results publicationCarmichael J: UKCCCR trial of epirubicin and cyclophosphamide (EC) vs. epirubicin and taxol (ET) in the first line treatment of women with metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-84, 2001.
- Results publicationCarmichael J: UKCCCR trial of epirubucin and cyclophosphamide (EC) versus epirubicin and taxol (ET) in the first line treatment of women with metastatic breast cancer (MBC). [Abstract] Br J Cancer 85 (suppl 1): A-CT6, 2, 2001.
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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.
James Carmichael, MD, PhD study chair
Nottingham City Hospital
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclophosphamide, epirubicin hydrochloride and paclitaxel in people with Breast Cancer, run by Medical Research Council at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom, South Africa. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002953, which also lists 3 linked publications.
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 4 Dec 2013.