AdenocarcinomaPhase 3NCT00140075
Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer
A Phase 3 study testing Epirubicin with Cyclophosphamide, followed by a Taxane and Epirubicin with a Taxane in people with Adenocarcinoma, run by Pfizer at 54 sites in United States.
Trial summary
The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Epirubicin with Cyclophosphamide, followed by a Taxane and Epirubicin with a Taxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 54 sitesUnited States
- Study dates
- Nov 2000to Aug 2006
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast Cancer Stage T1-3, N1, M0
- Suitable candidate for anthracycline-containing adjuvant chemotherapy
Who cannot join
- Evidence of residual tumor following surgery, or metastatic disease
- Received prior therapy for breast cancer
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Arlington, Virginia, 22205
Pfizer Investigational Site
Atlanta, Georgia, 30309
Pfizer Investigational Site
Bakersfield, California, 93309
Pfizer Investigational Site
Baltimore, Maryland, 21236
Pfizer Investigational Site
Baltimore, Maryland, 21237
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809
Pfizer Investigational Site
Belleville, Illinois, 62226
Pfizer Investigational Site
Berkeley, California, 94704
Pfizer Investigational Site
Boston, Massachusetts, 02120
Pfizer Investigational Site
Brooklyn, New York, 11235
Pfizer Investigational Site
Burlington, North Carolina, 27216
Pfizer Investigational Site
Charleston, South Carolina
Pfizer Investigational Site
Colorado Springs, Colorado, 80907
Pfizer Investigational Site
Columbia, South Carolina, 29201
Pfizer Investigational Site
Corpus Christi, Texas, 78412
Pfizer Investigational Site
Fountain Valley, California, 92708
Pfizer Investigational Site
Fountian Valley, California, 92708
Pfizer Investigational Site
Germantown, Tennessee, 38138
Pfizer Investigational Site
Gilroy, California, 95020
Pfizer Investigational Site
Great Neck, New York, 11021'
Pfizer Investigational Site
Greenville, North Carolina, 27854
Pfizer Investigational Site
Harper Woods, Michigan
Pfizer Investigational Site
Hattiesburg, Mississippi, 39401
Pfizer Investigational Site
Jackson, Mississippi, 39202
Pfizer Investigational Site
Jacksonville, Florida, 32224
Pfizer Investigational Site
Jacksonville, Florida
Pfizer Investigational Site
Kissimmee, Florida, 34741
Pfizer Investigational Site
Knoxville, Tennessee, 37923
Pfizer Investigational Site
Lake Worth, Florida, 33461
Pfizer Investigational Site
Lawton, Oklahoma, 73505
Pfizer Investigational Site
Lecanto, Florida, 34461
Pfizer Investigational Site
Lemoyne, Pennsylvania, 17043
Pfizer Investigational Site
Macon, Georgia, 31201
Pfizer Investigational Site
Miami, Florida, 33176
Pfizer Investigational Site
Miami Shores, Florida, 33138
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Mount Holly, New Jersey, 08060
Pfizer Investigational Site
New Orleans, Louisiana
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19106
Pfizer Investigational Site
Port Saint Lucie, Florida, 34952
Pfizer Investigational Site
Portsmouth, Virginia, 23704
Pfizer Investigational Site
Poway, California, 92064
Pfizer Investigational Site
Raleigh, North Carolina, 27607
Pfizer Investigational Site
Richmond, Virginia, 23226
Pfizer Investigational Site
Skokie, Illinois, 60076
Pfizer Investigational Site
Soquel, California, 95073
Pfizer Investigational Site
Staten Island, New York, 10310
Pfizer Investigational Site
Tampa, Florida, 33607
Pfizer Investigational Site
Tucson, Arizona, 85712
Pfizer Investigational Site
Tyler, Texas, 11937
Pfizer Investigational Site
Willingboro, New Jersey, 08046
About this study
Official title: Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer
The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.
- Conditions
- Adenocarcinoma
- Being tested
- Epirubicin with Cyclophosphamide, followed by a Taxane, Epirubicin with a Taxane
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epirubicin with Cyclophosphamide, followed by a TaxaneDrug
Also called Epirubicin, ellence,
Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2
Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2
Epirubicin with a TaxaneDrug
Also called Epirubicin, ellence,
Epirubicin = 75 mg/m2 per cycle
Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| B | Experimental | ET (8 cycles)
T = docetaxel or paclitaxel Receives: Drug: Epirubicin with a Taxane |
| A | Experimental | EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles
T = docetaxel or paclitaxel Receives: Drug: Epirubicin with Cyclophosphamide, followed by a Taxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival at 3 years
Measured: 3 years
Secondary outcomes (2)
Assess safety in both treatment arms at 3 years
Measured: 3 years
Compare overall survival between the 2 treatment arms at 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startNov 2000
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140075
- Sponsor's protocol ID
- 378-ONC-0030-184
- Status last verified
- May 2011
- First submitted
- 29 Aug 2005
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00140075
- Acronym / sponsor ID
- 378-ONC-0030-184
- Conditions
- Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2000
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 31 Aug 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.
The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Experimental | Drug: Epirubicin with a TaxaneET (8 cycles) T = docetaxel or paclitaxel |
| A | Experimental | Drug: Epirubicin with Cyclophosphamide, followed by a TaxaneEC (4 cycles) followed by T (4 cycles) for a total of 8 cycles T = docetaxel or paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast Cancer Stage T1-3, N1, M0
- Suitable candidate for anthracycline-containing adjuvant chemotherapy
Key exclusion criteria (2 listed)
- Evidence of residual tumor following surgery, or metastatic disease
- Received prior therapy for 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 |
|---|---|---|
| Epirubicin with Cyclophosphamide, followed by a TaxaneAlso: Epirubicin, ellence,Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2 Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 | Drug | A |
| Epirubicin with a TaxaneAlso: Epirubicin, ellence,Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 | Drug | B |
Primary outcome
Disease free survival at 3 years
Time frame: 3 years
2 secondary outcomes
Assess safety in both treatment arms at 3 years
Time frame: 3 years
Compare overall survival between the 2 treatment arms at 3 years
Time frame: 3 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 26 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
54 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 Epirubicin with Cyclophosphamide, followed by a Taxane and Epirubicin with a Taxane in people with Adenocarcinoma, run by Pfizer at 54 sites in United States.
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 2 inclusion and 2 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 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States. 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 survival at 3 years (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 26 May 2011.