Back to resultsA Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.
Primary Purpose
Breast Neoplasms
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
docetaxel
PF-3512676
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Female patients with confirmed advanced breast cancer.
- Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
- Patients with adequate general well-being, kidney and liver function.
Exclusion Criteria:
- Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
- Patients who have had prior chemotherapy for advanced breast cancer.
- Patients of child-bearing potential who are unwilling to use contraception.
Sites / Locations
Outcomes
Primary Outcome Measures
Progression-free survival
Tumor assessment every 6 weeks until disease progression
Secondary Outcome Measures
Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
Overall Survival - Patients will be followed for survival
Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up
Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00471159
Brief Title
A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.
Official Title
A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
PF-3512676
Primary Outcome Measure Information:
Title
Progression-free survival
Title
Tumor assessment every 6 weeks until disease progression
Secondary Outcome Measure Information:
Title
Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
Title
Overall Survival - Patients will be followed for survival
Title
Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up
Title
Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients with confirmed advanced breast cancer.
Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
Patients with adequate general well-being, kidney and liver function.
Exclusion Criteria:
Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
Patients who have had prior chemotherapy for advanced breast cancer.
Patients of child-bearing potential who are unwilling to use contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8501007&StudyName=A%20Study%20Of%20Docetaxel%20Or%20Docetaxel%20Plus%20PF-3512676%20To%20Treat%20Patients%20With%20Advanced%20Breast%20Cancer.
Description
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A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.
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