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

Study Overview
=================
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.

Official Title
-----------------
A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer

Conditions
-----------------
Breast Neoplasms, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Drug: Edotecarin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Edotecarin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor response (TAR) |  |  | 
| Duration of response (DR) |  |  | 
| Time to tumor progression (TTP) |  |  | 
| Time to treatment failure (TTF) |  |  | 
| Overall survival (OS) |  |  | 
| Clinical benefit |  |  | 
| 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] |  |  | 
| performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2] |  |  | 
| Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC] |  |  | 
| [Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities. |  |  | 
| Plasma pharmacokinetic parameters |  |  |