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COMPLETEDPHASE2

Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer

NCT00303108•US Oncology Research

Summary

The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has metastatic breast cancer with documented HER2- or HER2+ (IHC3+ or FISH+) disease
•Has measurable MBC, with at least 1 measurable lesion per RECIST criteria (see Section 10). Irradiated lesions cannot be used to assess response but can be used to assess progression.
•Has had no prior treatment with Doxil or carboplatin; may have had adjuvant Herceptin if treatment was completed more than 1 year prior to study
•Has had no adjuvant chemotherapy within 1 year prior to study, but may have received prior anthracyclines as adjuvant chemotherapy
•For taxane-pretreated patients (adjuvant or metastatic), has had no more than 1 prior chemotherapy regimen for MBC
•For taxane-naïve patients, has had no prior chemotherapy for MBC
•Has had cumulative doses of \< 300 mg/m2 prior doxorubicin or \< 450 mg/m2 prior epirubicin
•Has normal cardiac function as evidenced by a LVEF within institutional normal limits by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same test must be used throughout the study to evaluate LVEF.
•Has an ECOG Performance Status (PS) 0-2 (see Appendix I)
•Is a male or female greater than or equal to 18 years of age
+6 more criteria

Exclusion Criteria

•Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA; see Appendix IV) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
•Has a history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil
•Has evaluable only disease; eg, bone only, pleural, peritoneal only disease
•Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Patients receiving immunosuppressant therapy for autoimmune disease may enroll on the trial after a drug washout period of 2 weeks.
•Is receiving concurrent investigational therapy or has received such therapy within 30 days
•Has evidence of brain metastases requiring steroids and/or radiation or any documented leptomeningeal disease
•Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection or history of uncontrolled seizures, CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
•Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
•Is a pregnant or lactating woman
•Is unable to comply with requirements of study

Locations (57)

Birmingham Hematology and Oncology

Birmingham, Alabama, United States

Hematology Oncology Associates

Phoenix, Arizona, United States

Northern AZ Hematology & Oncology Associates-Sedona

Sedona, Arizona, United States

Rocky Mountain Cancer Center-Rose

Denver, Colorado, United States

Florida Cancer Institute

New Port Richey, Florida, United States

Ocala Oncology Center

Ocala, Florida, United States

Hematology Oncology Associates of IL

Chicago, Illinois, United States

Cancer Care & Hematology Specialists of Chicagoland, PC

Niles, Illinois, United States

Central Indiana Cancer Centers

Indianapolis, Indiana, United States

Kansas City Cancer Centers-Southwest

Overland Park, Kansas, United States

Key Dates

Start Date

December 1, 2005

Primary Completion Date

March 1, 2010

Completion Date

June 1, 2011

Last Updated

November 3, 2016

Enrollment

136

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Pegylated liposomal doxorubicin

DRUG

Carboplatin

DRUG

trastuzumab

DRUG

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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 3, 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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Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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