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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

NCT00067314•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (19)

Pfizer Investigational Site

Manhasset, New York, United States

Pfizer Investigational Site

New York, New York, United States

Pfizer Investigational Site

Cleveland, Ohio, United States

Pfizer Investigational Site

Cleveland, Ohio, United States

Pfizer Investigational Site

Orange, Ohio, United States

Pfizer Investigational Site

Westlake, Ohio, United States

Pfizer Investigational Site

Nashville, Tennessee, United States

Pfizer Investigational Site

East Bentleigh, Victoria, Australia

Pfizer Investigational Site

Parkville, Victoria, Australia

Pfizer Investigational Site

Brussels, Belgium

Key Dates

Start Date

June 1, 2003

Primary Completion Date

June 1, 2007

Completion Date

June 1, 2007

Last Updated

January 18, 2012

Enrollment

Estimated participants

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Edotecarin

DRUG

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

View study

RECRUITING

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

A Study of LY4175408 in Participants With Advanced Cancer