Breast NeoplasmsPhase 2NCT00072852
Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
A Phase 2 study testing Irinotecan in people with Breast Neoplasms, run by Pfizer at 66 sites in 5 countries.
Trial summary
The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Irinotecan
- How many people
- 134 participants
- Where
- 66 sitesin 5 countries
- Study dates
- Nov 2003to May 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
- Women with diagnosis of primary adenocarcinoma of the breast
- Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent
- At least one measurable lesion >20mm (or >10 mm with spiral CT scan)
- Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting
- Women at least 18 years old, with performance status 0-2
Who cannot join
- Prior treatment with another topoisomerase I inhibitor
- Current enrollment in another clinical trial
Trial locations and contacts
66 sites in 5 countries.
66 sites in 5 countries
United States57 sites
Pfizer Investigational Site
Alton, Illinois, 62002
Pfizer Investigational Site
Anchorage, Alaska, 99508
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02130
Pfizer Investigational Site
Chalmette, Louisiana, 70043
Pfizer Investigational Site
Covington, Louisiana, 70433
Pfizer Investigational Site
Covington, Tennessee, 38019
Pfizer Investigational Site
Dallas, Texas, 75204
Pfizer Investigational Site
Dallas, Texas, 75230-2510
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Federal Way, Washington, 98003
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Franklin, Tennessee, 37067
Pfizer Investigational Site
Gallatin, Tennessee, 37066
Pfizer Investigational Site
Greenville, South Carolina, 29615
Pfizer Investigational Site
Hermitage, Tennessee, 37076
Pfizer Investigational Site
Indianapolis, Indiana, 46227
Pfizer Investigational Site
Kansas City, Missouri, 64111
Pfizer Investigational Site
Kettering, Ohio, 45409
Pfizer Investigational Site
Lakewood, Washington, 98499
Pfizer Investigational Site
Lebanon, Tennessee, 37087
Pfizer Investigational Site
Lewistown, Idaho, 83501
Pfizer Investigational Site
Mandeville, Louisiana, 70448
Pfizer Investigational Site
Memphis, Tennessee, 38120
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Milwaukee, Wisconsin, 53215
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Murfreesboro, Tennessee, 37130
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
Nashville, Tennessee, 37205
Pfizer Investigational Site
Nashville, Tennessee, 37207
Pfizer Investigational Site
Nashville, Tennessee, 37211
Pfizer Investigational Site
New Brunswick, New Jersey, 08901-2601
Pfizer Investigational Site
New Brunswick, New Jersey, 08903
Pfizer Investigational Site
New Orleans, Louisiana, 70115
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73120
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Plano, Texas, 75075-7787
Pfizer Investigational Site
Seattle, Washington, 98104-2499
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98109-1023
Pfizer Investigational Site
Seattle, Washington, 98122
Pfizer Investigational Site
Seattle, Washington, 98195
Pfizer Investigational Site
Southaven, Mississippi, 38671
Pfizer Investigational Site
St Louis, Missouri, 63136
Pfizer Investigational Site
St Louis, Missouri, 63141
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tyler, Texas, 75702
Pfizer Investigational Site
Vancouver, Washington, 98684
Pfizer Investigational Site
Washington, Missouri, 63090
Pfizer Investigational Site
Yakima, Washington, 98902
Argentina5 sites
Pfizer Investigational Site
Capital Federal, Buenos Aires, 1426
Pfizer Investigational Site
Capital Federal, 1406
Pfizer Investigational Site
Córdoba, Córdoba Province, 5000
Pfizer Investigational Site
Rosario, Santa Fe Province, 2000
Pfizer Investigational Site
Santa Fe, Santa Fe Province, 3000
Australia2 sites
Pfizer Investigational Site
Frankston, Victoria, 3199
Pfizer Investigational Site
South Brisbane, Queensland, 4101
About this study
Official title: Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.
- Conditions
- Breast Neoplasms
- Being tested
- Irinotecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2003 (estimated)
- Study startNov 2003
- Primary completionMay 2007
- Study completionMay 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 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
- NCT00072852
- Sponsor's protocol ID
- CPTAPO-0047-146
- Other IDs
- A5961023
- Status last verified
- Oct 2008
- First submitted
- 11 Nov 2003
- Last updated
- 16 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
- ClinicalTrials.gov ID
- NCT00072852
- Acronym / sponsor ID
- CPTAPO-0047-146
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 13 Nov 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.
The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (5 listed)
- Women with diagnosis of primary adenocarcinoma of the breast
- Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent
- At least one measurable lesion >20mm (or >10 mm with spiral CT scan)
- Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting
- Women at least 18 years old, with performance status 0-2
Key exclusion criteria (2 listed)
- Prior treatment with another topoisomerase I inhibitor
- Current enrollment in another clinical trial
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 |
|---|---|---|
| Irinotecan | Drug | – |
Primary outcome
To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.
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 16 Oct 2008.
- 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
66 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan in people with Breast Neoplasms, run by Pfizer at 66 sites in 5 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 5 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 16 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Argentina, Australia, Colombia, New Zealand. 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 evaluate the safety and efficacy of Irinotecan in refractory breast cancer.. 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 16 Oct 2008.