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TERMINATEDPHASE1

Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Parallel Phase I Study of Ixabepilone Plus Lapatinib and Ixabepilone Plus Lapatinib Plus Capecitabine in Subjects With HER2 Positive Locally Advanced or Metastatic Breast Cancer

NCT00634088•R-Pharm

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
•Radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as radiation or surgery
•Positive status for human epidermal growth factor receptor 2
•Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines
•Karnofsky performance status of 70 to 100
•Life expectancy of at least 3 months

Exclusion Criteria

•Prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
•Common Terminology Criteria Grade 2 or greater neuropathy
•Inadequate hematologic, hepatic, or renal function
•Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or known hypersensitivity or prior intolerance to fluoropyrimidine
•Known or suspected dihydropyrimidine dehydrogenase deficiency
•More than 3 prior chemotherapy regimens in the metastatic setting
•Prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months

Locations (3)

The Cancer Institute Of New Jersey

New Brunswick, New Jersey, United States

Local Institution

Brisbane, Queensland, Australia

Local Institution

Modena, Italy

Key Dates

Start Date

June 1, 2008

Primary Completion Date

June 1, 2010

Completion Date

June 1, 2010

Last Updated

March 10, 2016

Enrollment

ACTUAL participants

Conditions

Locally Advanced or Metastatic Breast Cancer

Interventions

Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg

DRUG

Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg

DRUG

Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg

DRUG

Ixabepilone + Lapatinib + Capecitabine

DRUG

A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

NCT06680921

Locally Advanced or Metastatic Breast Cancer

View study

COMPLETEDPHASE3

A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer

NCT02514681

HER2-positive Locally Advanced or Metastatic Breast Cancer

View study

COMPLETED

Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy

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: March 10, 2016Data 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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