Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer

This is an interventional treatment trial for Breast Carcinoma Read More

Inclusion Criteria:

• Patients must have histological confirmation of breast carcinoma

• Patients must have invasive breast cancer (IBC), confirmed according to international consensus criteria:

  • Onset: Rapid onset of breast erythema, edema, and/or peau d'orange, and/or warm breast, with or without an underlying breast mass
  • Duration: History of such findings no more than 6 months
  • Extent: Erythema occupying at least 1/3 of whole breast
  • Pathology: Pathologic confirmation of invasive carcinoma
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patients must have negative HER2 expression on immunohistochemistry (IHC) (defined as 0 or 1+) or fluorescence in situ hybridization (FISH) analysis; if HER2 is 2+, negative HER2 expression must be confirmed by FISH (HER2/cep17 ration < 2, and/or copy number less than 6); ER and PgR expression should be less than 10%
• Patients have left ventricular ejection fraction (LVEF) >= 50% by multigated acquisition scan (MUGA) or echocardiogram before study randomization
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
• Platelet count >= 100 x 10^9/L
• Hemoglobin >= 9.0 g/dL
• Aspartate aminotransferase (AST) =< 3.0 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) =< 3.0 x ULN
• Alkaline phosphatase (ALP) =< 2.5 x ULN
• Total bilirubin =< 1.5 x ULN
• Creatinine (Cr) =< 1.5 mg/dL x ULN
• Creatinine clearance (CrCl) >= 50 mL/min calculated by the Cockroft-Gault
• Patients have the ability and willingness to sign written informed consent
• Patients of childbearing potential (women who are postmenopausal for < 1 year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subject's entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide

Exclusion Criteria:

• Stage IV disease, if the metastatic sites are not amendable for local therapy (i.e. radiation and/or surgery), and are not candidates for breast surgery will not be eligible
• History of radiotherapy for current breast cancer diagnosis
• History of recent malignancies < 5 years (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ)
• Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
• History of extensive interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest computed tomography (CT) scan
• Other known other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with a peripheral neuropathy > grade 1
• Patients with a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina, or cerebrovascular accident (CVA) within 6 months of protocol registration
• Patients have a history of prior therapy with carboplatin
• Patients have received a cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2
• Patients have had prior radiotherapy for primary breast carcinoma or axillary lymph nodes
• Patients have history of diagnosed interstitial lung disease