NCT00471159

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

First QC Date

May 7, 2007

Last Update Submit

April 30, 2015

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

  • Tumor assessment every 6 weeks until disease progression

Secondary Outcomes (4)

  • 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

Interventions

docetaxelDRUG
PF-3512676DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who have had prior chemotherapy for advanced breast cancer.
  • Patients of child-bearing potential who are unwilling to use contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelProMune

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 7, 2007

First Posted

May 9, 2007

Study Start

August 1, 2007

Last Updated

May 4, 2015

Record last verified: 2015-04