Breast CancerPhase 2NCT00678626
Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer
A Phase 2 study testing CP-751,871 and Docetaxel in people with Breast Cancer, run by Pfizer.
Trial summary
This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization. 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?
- CP-751,871 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Sep 2011
- 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
- histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
- Her-2negative breast cancer or unknown Her-2 status.
- at least 1 measurable lesion as defined by RECIST.
- ECOG status 0-1
- adequate bone marrow, hepatic and renal function.
- left ventricular ejection fraction of greater than or equal to 50%.
- willingness to discontinue hormonal therapy.
Who cannot join
- any previous chemotherapy for advanced disease.
- prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
- symptomatic brain metastases.
- prior anti-IGF-1R based investigational therapy.
- peripheral neuropathy greater than grade 2.
About this study
Official title: A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer
This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.
- Conditions
- Breast Cancer
- Being tested
- CP-751,871, Docetaxel
- Keywords
- Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-751,871Drug
Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped.
DocetaxelDrug
Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | combination of CP-751,871 + docetaxel administered Receives: Drug: CP-751,871 |
| Arm B | Active comparator | chemotherapy Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 3 years
Secondary outcomes (7)
Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)
Measured: 3 years
Overall Response
Measured: 3 years
Overall Survival
Measured: 3 years
Safety and tolerability
Measured: 3 years
Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire
Measured: 3 years
Pharmacokinetics of CP-751,871
Measured: 3 years
Optional tissue markers of the IGF-1R pathway from tumor tissue obtained
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 posted15 May 2008 (estimated)
- Study startApr 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 0 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
- NCT00678626
- Sponsor's protocol ID
- A4021008
- Status last verified
- Apr 2015
- First submitted
- 12 May 2008
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00678626
- Acronym / sponsor ID
- A4021008
- Conditions
- Breast Cancer
- Keywords
- Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 15 May 2008 (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 study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: CP-751,871combination of CP-751,871 + docetaxel administered |
| Arm B | Active comparator | Drug: Docetaxelchemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
- Her-2negative breast cancer or unknown Her-2 status.
- at least 1 measurable lesion as defined by RECIST.
- ECOG status 0-1
- adequate bone marrow, hepatic and renal function.
Key exclusion criteria (5 listed)
- any previous chemotherapy for advanced disease.
- prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
- symptomatic brain metastases.
- prior anti-IGF-1R based investigational therapy.
- peripheral neuropathy greater than grade 2.
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 |
|---|---|---|
| CP-751,871Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped. | Drug | Arm A |
| DocetaxelDocetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted. | Drug | Arm B |
Primary outcome
Progression Free Survival
Time frame: 3 years
7 secondary outcomes
Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)
Time frame: 3 years
Overall Response
Time frame: 3 years
Overall Survival
Time frame: 3 years
Safety and tolerability
Time frame: 3 years
Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire
Time frame: 3 years
Pharmacokinetics of CP-751,871
Time frame: 3 years
Optional tissue markers of the IGF-1R pathway from tumor tissue obtained
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-751,871 and Docetaxel in people with Breast Cancer, run by Pfizer.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 4 May 2015. 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 withdrawn before enrolling participants, so there are no results.
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?
Progression Free Survival (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 4 May 2015.