Breast CancerPhase 2NCT00193024
Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer
A Phase 2 study testing Docetaxel and Epirubicin in people with Breast Cancer, run by SCRI Development Innovations, LLC.
Trial summary
The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel and Epirubicin
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Oct 2004
- Phase
- Phase 2
- 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
- To be included in this study, you must meet the following criteria:
- Metastatic breast cancer confirmed by biopsy.
- Received no previous chemotherapy for metastatic breast cancer.
- Prior hormonal therapy is acceptable.
- Measurable or evaluable disease.
- Able to perform activities of daily living without considerable assistance
- Adequate bone marrow, liver and kidney function
- Must be able to understand the nature of this study and give written informed consent.
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Age < 18 years.
- Cardiac ejection fraction < 45%.
- Women who are pregnant or lactating.
- Patients with meningeal metastases are ineligible.
- Moderate peripheral neuropathy
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- History of hypersensitivity reaction to Taxotere
- Males with metastatic breast cancer
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
About this study
Official title: A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer
The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.
Read the detailed description
Upon determination of eligibility, all patients will receive:
Docetaxel + Epirubicin
Both drugs will be repeated at 21-day intervals
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Epirubicin
- 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
EpirubicinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Secondary outcomes (1)
Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2001
- Primary completionOct 2003
- Study completionOct 2004
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Pharmacia and Upjohn
- Investigators
- John D. Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193024
- Sponsor's protocol ID
- SCRI BRE 39
- Other IDs
- 378-ONC-0030-219, GIA 11168
- Status last verified
- May 2011
- First submitted
- 12 Sep 2005
- Last updated
- 3 May 2011
- Results posted
- No
Publications
Hainsworth JD, Yardley DA, Spigel DR, Meluch AA, Rinaldi D, Schnell FM, Greco FA. Docetaxel and epirubicin as first-line treatment for patients with metastatic breast cancer: a Minnie Pearl Cancer Research Network Phase II trial. Cancer Invest. 2006 Aug-Sep;24(5):469-73. doi: 10.1080/07357900600814060.
PubMed 16939953
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00193024
- Acronym / sponsor ID
- SCRI BRE 39
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Pharmacia and Upjohn
- Study start
- Sep 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 19 Sep 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 epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.
Detailed description
Upon determination of eligibility, all patients will receive:
Docetaxel + Epirubicin
Both drugs will be repeated at 21-day intervals
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Metastatic breast cancer confirmed by biopsy.
- Received no previous chemotherapy for metastatic breast cancer.
- Prior hormonal therapy is acceptable.
- Measurable or evaluable disease.
- Able to perform activities of daily living without considerable assistance
Key exclusion criteria (9 listed)
- Age < 18 years.
- Cardiac ejection fraction < 45%.
- Women who are pregnant or lactating.
- Patients with meningeal metastases are ineligible.
- Moderate peripheral neuropathy
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 |
|---|---|---|
| Docetaxel | Drug | – |
| Epirubicin | Drug | – |
Primary outcome
Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
1 secondary outcome
Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2011.
- Results publication: PubMed 16939953Hainsworth JD, Yardley DA, Spigel DR, Meluch AA, Rinaldi D, Schnell FM, Greco FA. Docetaxel and epirubicin as first-line treatment for patients with metastatic breast cancer: a Minnie Pearl Cancer Research Network Phase II trial. Cancer Invest. 2006 Aug-Sep;24(5):469-73. doi: 10.1080/07357900600814060.
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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.
John D. Hainsworth, MD principal investigator
SCRI Development Innovations, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Epirubicin in people with Breast Cancer, run by SCRI Development Innovations, LLC.
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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer. 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 NCT00193024, 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 3 May 2011.