Breast NeoplasmsPhase 2NCT00067314
Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy
A Phase 2 study testing Edotecarin in people with Breast Neoplasms and Neoplasm Metastasis, run by Pfizer at 19 sites in 4 countries.
Trial summary
This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Neoplasm Metastasis
- What is being tested?
- Edotecarin
- How many people
- 65 participants
- Where
- 19 sitesin 4 countries
- Study dates
- Jun 2003to Jun 2007
- 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
- Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
- Must have received any chemotherapy regimen in the past
- Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
- Must have measurable (by imaging techniques) disease
- Adequate bone marrow, liver and renal function
- Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.
Who cannot join
- Received more than 2 prior chemotherapy regimens for metastatic disease
- Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
- Enrolled in another clinical intervention study
- Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
- Cardiac or thrombotic event in the last 12 months
- Brain metastases
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
United States7 sites
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Cleveland, Ohio, 44121
Pfizer Investigational Site
Manhasset, New York, 11030
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Orange, Ohio, 44122
Pfizer Investigational Site
Westlake, Ohio, 44145
Belgium5 sites
Pfizer Investigational Site
Brussels, 1090
Pfizer Investigational Site
Charleroi, B-6000
Pfizer Investigational Site
Haine-Saint-Paul, 7100
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Wilrijk, 2610
France5 sites
Pfizer Investigational Site
Dijon, 21034
Pfizer Investigational Site
Montpellier, 34059
Pfizer Investigational Site
Paris, 75015
Pfizer Investigational Site
Toulouse, 31052
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54511
Australia2 sites
Pfizer Investigational Site
East Bentleigh, Victoria, 3165
Pfizer Investigational Site
Parkville, Victoria, 3050
About this study
Official title: A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer
This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Being tested
- Edotecarin
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdotecarinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
Secondary outcomes (12)
Time to tumor response (TAR)
Duration of response (DR)
Time to tumor progression (TTP)
Time to treatment failure (TTF)
Overall survival (OS)
Clinical benefit
ie, a composite profile of pain intensity
analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]
performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]
Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]
[Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.
Plasma pharmacokinetic parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2003 (estimated)
- Study startJun 2003
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067314
- Sponsor's protocol ID
- EDOABC-4439-001
- Status last verified
- Jan 2012
- First submitted
- 15 Aug 2003
- Last updated
- 18 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00067314
- Acronym / sponsor ID
- EDOABC-4439-001
- Conditions
- Breast Neoplasms, Neoplasm Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 18 Aug 2003 (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.
This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.
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 (6 listed)
- Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
- Must have received any chemotherapy regimen in the past
- Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
- Must have measurable (by imaging techniques) disease
- Adequate bone marrow, liver and renal function
Key exclusion criteria (6 listed)
- Received more than 2 prior chemotherapy regimens for metastatic disease
- Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
- Enrolled in another clinical intervention study
- Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
- Cardiac or thrombotic event in the last 12 months
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 |
|---|---|---|
| Edotecarin | Drug | – |
Primary outcome
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
12 secondary outcomes
Time to tumor response (TAR)
Duration of response (DR)
Time to tumor progression (TTP)
Time to treatment failure (TTF)
Overall survival (OS)
Clinical benefit
ie, a composite profile of pain intensity
analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]
performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]
Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]
[Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.
Plasma pharmacokinetic parameters
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 18 Jan 2012.
- 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
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Edotecarin in people with Breast Neoplasms and Neoplasm Metastasis, run by Pfizer at 19 sites in 4 countries.
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 6 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 18 Jan 2012. 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 States, Belgium, France, Australia. 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 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 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?
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate. 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 18 Jan 2012.