Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS) Rate

Outcome Description:

PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.

Outcome Time Frame:

Baseline up to Week 16

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3160A2-201

NCT ID:

NCT00319254

Start Date:

May 2006

Completion Date:

February 2009

Related Keywords:

• Breast Neoplasms
• Neoplasm Metastasis
• Advanced Breast Cancer
• Breast Neoplasms
• Neoplasms
• Neoplasm Metastasis