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):

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Neoplasm Metastasis Drug: Edotecarin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer
Study Start Date : June 2003
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00067314

United States, New York
Pfizer Investigational Site
Manhasset, New York, United States, 11030
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site
Cleveland, Ohio, United States, 44121
Pfizer Investigational Site
Orange Village, Ohio, United States, 44122
Pfizer Investigational Site
Westlake, Ohio, United States, 44145
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Australia, Victoria
Pfizer Investigational Site
East Bentleigh, Victoria, Australia, 3165
Pfizer Investigational Site
Parkville, Victoria, Australia, 3050
Pfizer Investigational Site
Brussel, Belgium, 1090
Pfizer Investigational Site
Charleroi, Belgium, B-6000
Pfizer Investigational Site
Haine St. Paul, Belgium, 7100
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
Wilrijk, Belgium, 2610
Pfizer Investigational Site
Dijon, France, 21034
Pfizer Investigational Site
Montpellier, France, 34059
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Toulouse Cedex, France, 31052
Pfizer Investigational Site
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT00067314     History of Changes
Other Study ID Numbers: EDOABC-4439-001
First Posted: August 18, 2003    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents