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Clinical Trials/NCT00471159
NCT00471159
Withdrawn
Phase 2

A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer

Pfizer0 sitesAugust 2007
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ConditionsBreast Neoplasms
DrugsdocetaxelPF-3512676

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Pfizer
Primary Endpoint
Progression-free survival
Status
Withdrawn
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Pfizer

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.

Outcomes

Primary Outcomes

Progression-free survival

Tumor assessment every 6 weeks until disease progression

Secondary Outcomes

  • 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

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