A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00471159
• Other study ID #: A8501007
• Status: Withdrawn
• Phase: Phase 2
• First received: May 7, 2007
• Last updated: April 30, 2015
• Start date: August 2007

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• docetaxel

• PF-3512676

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival
Primary	Tumor assessment every 6 weeks until disease progression
Secondary	Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
Secondary	Overall Survival - Patients will be followed for survival
Secondary	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
Secondary	Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy

External Links

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