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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Manhasset, New York, 11030 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms, Neoplasm Metastasis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00067314
Pfizer
Completed
Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy

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[email protected]

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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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • Neoplasm Metastasis
Drug: Edotecarin
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
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, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   United States
 
 
NCT00067314
EDOABC-4439-001
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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