Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy

Completed · Phase 2

Conditions studied: Breast Neoplasms, Neoplasm Metastasis

In brief

This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.

Key facts

Study ID

NCT00067314

Run by

Pfizer

People needed

65

Starts

2003-06-01

Expected to finish

2007-06-01

Last updated by the study team

2012-01-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
• Must have received any chemotherapy regimen in the past
• Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
• Must have measurable (by imaging techniques) disease
• Adequate bone marrow, liver and renal function
• Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.

You may not qualify if…

• Received more than 2 prior chemotherapy regimens for metastatic disease
• Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
• Enrolled in another clinical intervention study
• Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
• Cardiac or thrombotic event in the last 12 months
• Brain metastases

Where it is running

• Pfizer Investigational Site — Manhasset, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Orange, Ohio, United States
• Pfizer Investigational Site — Westlake, Ohio, United States
• Pfizer Investigational Site — Nashville, Tennessee, United States
• Pfizer Investigational Site — East Bentleigh, Victoria, Australia
• Pfizer Investigational Site — Parkville, Victoria, Australia
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Charleroi, Belgium
• Pfizer Investigational Site — Haine-Saint-Paul, Belgium
• Pfizer Investigational Site — Leuven, Belgium
• Pfizer Investigational Site — Wilrijk, Belgium
• Pfizer Investigational Site — Dijon, France
• Pfizer Investigational Site — Montpellier, France
• Pfizer Investigational Site — Paris, France
• Pfizer Investigational Site — Toulouse, France
• Pfizer Investigational Site — Vandœuvre-lès-Nancy, France

Full record on ClinicalTrials.gov

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