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Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer

NCT00093145•Celgene

View on ClinicalTrials.gov

Summary

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants 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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Confirmed adenocarcinoma of the breast
•Tumor shows 3+ overexpression of the human epidermal growth factor receptor 2 (HER-2)/proto-oncogene by immunohistochemistry assay, or is fluorescence in situ hybridization (FISH)+
•Stage IV disease
•Measurable disease
•At least 3 weeks since prior cytotoxic chemotherapy
•At least 4 weeks since radiotherapy with full recovery
•At least 4 weeks since major surgery with full recovery
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•At least 18 years old
•Absolute neutrophil count (ANC) at least 1.5 x 10\^9 cells/L
+9 more criteria

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/m\^2
•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

Locations (14)

Breastlink Med Group

Long Beach, California, United States

Hematology/Oncology P.C. Carl & Dorothy Bennet Cancer Center

Stamford, Connecticut, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Lombardi Cancer Center Georgetown University Hospital

Washington D.C., District of Columbia, United States

Florida Cancer Institute

Hudson, Florida, United States

Gulf Coast Oncology Associates

St. Petersburg, Florida, United States

Palm Beach Cancer Institute

West Palm Beach, Florida, United States

Gerogia Cancer Specialist

Atlanta, Georgia, United States

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

June 1, 2004

Primary Completion Date

October 1, 2008

Completion Date

October 1, 2008

Last Updated

November 25, 2019

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Albumin-bound paclitaxel

DRUG

Carboplatin

DRUG

Herceptin®

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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RECRUITINGPHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

NCT05372640

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+6 more

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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: November 25, 2019Data 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.

View ClinicalTrials.gov Terms and Conditions

Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer