Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer
Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer
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).
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

 -  Laboratory Values - Please refer to protocol section 4.2 for specific laboratory
 values.

 -  Has a negative serum pregnancy test within 7 days prior to registration (woman of
 childbearing potential [WOCBP; not surgically sterilized and between menarche and 1
 year postmenopause])

 -  If fertile, patient (male or female) has agreed to use an acceptable method of birth
 control (eg, abstinence, intrauterine device, oral contraceptives, barrier device with
 spermicide or surgical sterilization) to avoid pregnancy for the duration of the study
 and for a period of 3 months thereafter.

 -  Has signed a Patient Informed Consent Form

 -  Has signed a Patient Authorization Form (HIPAA Form)

 -  Has a life expectancy of > 3 months

 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