Study of ABI-007 in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer - Full Text View

Sponsored by:	Abraxis BioScience Inc.
Information provided by:	Abraxis BioScience Inc.
ClinicalTrials.gov Identifier:	NCT00093145

Purpose

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Carboplatin and Herceptin. Patients will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

Condition	Intervention	Phase
Breast Cancer	Drug: ABI-007	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Paclitaxel Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Abraxis BioScience Inc.:

Primary Outcome Measures:

Percentage of patients who achieve an objective confirmed complete or partial target lesion response based on the RECIST response criteria.

Secondary Outcome Measures:

Percentage of patients with stable disease for 16 weeks
time to disease progression
duration of response
patient survival

Estimated Enrollment:	100
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed adenocarcinoma of the breast
Tumor shows 3+ overexpression of the HER-2/proto-oncogene by immunohistochemistry assay, or is FISH+
Stage IV disease
Measurable disease
At least 3wks since prior cytotoxic chemotherapy
At least 4wks since radiotherapy with full recovery
At least 4wks since major surgery with full recovery
ECOG performance status 0-2
At least 18yrs old
ANC at least 1.5 x 10^9 cells/L
Platelets at least 100 x 10^9 cells/L
Hemoglobin at least 9 g/dL
AST, ALT less than 2.5X upper limit normal
Alkaline Phosphatase less than 1.5X upper limit normal
Creatinine less than 1.5 gm/dL
Normal left ventricular ejection fraction
Negative pregnancy test
Agree to use method to avoid pregnancy
Informed Consent is obtained

Exclusion Criteria:

Up to one regimen of prior neo-adjuvant or adjuvant chemotherapy is allowed. One year since Taxane and Herceptin treatment.
Cumulative life-time dose of doxorubicin is greater than 360 mg/m2
Concurrent immunotherapy or hormonal therapy
Parenchymal brain metastases, if present, must be documented to be clinically and radiographically stable for at least 6 months after treatment
Serious intercurrent medical or psychiatric illness, including serious active infection
History of congestive heart failure
History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer
Patients who have received an investigational drug within the previous 3 weeks
Patient is currently enrolled in another clinical study receiving investigational therapies
Pregnant or nursing women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093145

Locations

United States, North Carolina
Abraxis BioScience Inc.
Durham, North Carolina, United States, 27703

Sponsors and Collaborators

Abraxis BioScience Inc.

Investigators

Study Director:

Michael Hawkins

Abraxis BioScience Inc.

More Information

Study ID Numbers:	CA016-0
Study First Received:	October 4, 2004
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00093145
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abraxis BioScience Inc.:

Advanced Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Trastuzumab

Breast Neoplasms
Carboplatin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009