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

Phase 2

Completed

• Conditions: Breast Neoplasms; Neoplasm Metastasis

• Registration Number: NCT00067314
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-08-15
• Study First Submitted QC: 2003-08-15
• Study First Posted: 2003-08-18
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-13
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate

Secondary Outcome Measures

Name	Time	Method
Time to tumor response (TAR)
Time to tumor progression (TTP)
Clinical benefit
performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]
[Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.
Time to treatment failure (TTF)
ie, a composite profile of pain intensity
analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]
Duration of response (DR)
Overall survival (OS)
Plasma pharmacokinetic parameters
Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Vandoeuvre Les Nancy, France