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

NCT ID: NCT00067314

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-06-30

Brief Summary

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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

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Conditions

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Breast Neoplasms Neoplasm Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Edotecarin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Manhasset, New York, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Orange, Ohio, United States

Site Status

Pfizer Investigational Site

Westlake, Ohio, United States

Site Status

Pfizer Investigational Site

Nashville, Tennessee, United States

Site Status

Pfizer Investigational Site

East Bentleigh, Victoria, Australia

Site Status

Pfizer Investigational Site

Parkville, Victoria, Australia

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Pfizer Investigational Site

Charleroi, , Belgium

Site Status

Pfizer Investigational Site

Haine-Saint-Paul, , Belgium

Site Status

Pfizer Investigational Site

Leuven, , Belgium

Site Status

Pfizer Investigational Site

Wilrijk, , Belgium

Site Status

Pfizer Investigational Site

Dijon, , France

Site Status

Pfizer Investigational Site

Montpellier, , France

Site Status

Pfizer Investigational Site

Paris, , France

Site Status

Pfizer Investigational Site

Toulouse, , France

Site Status

Pfizer Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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United States Australia Belgium France

Related Links

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Other Identifiers

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EDOABC-4439-001

Identifier Type: -

Identifier Source: org_study_id

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