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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00067314
Recruitment Status : Completed
First Posted : August 18, 2003
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):

August 15, 2003
August 18, 2003
January 18, 2012
June 2003
June 2007   (Final data collection date for primary outcome measure)
To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
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Complete list of historical versions of study NCT00067314 on Archive Site
  • 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
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Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy
A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer
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.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Neoplasm Metastasis
Drug: Edotecarin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   United States
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Study Director: Pfizer Call Center Pfizer
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP