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2016-0177: A randomized phase II study of neoadjuvant carboplatin/paclitaxel (CT) versus panitumumab/carboplatin/paclitaxel (PaCT) followed by anthracycline-containing regimen for newly diagnosed primary triple-negative inflammatory breast cancer

Description

The goal of this clinical research study is to learn if adding panitumumab to the combination of carboplatin and paclitaxel can help to control inflammatory breast cancer when given before other standard chemotherapy and surgery. The safety of these drug combinations will also be studied.

This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of EGFR-expressing metastatic colorectal cancer with disease progression. Paclitaxel, carboplatin, doxorubicin and cyclophosphamide are FDA approved and commercially available for the treatment of breast cancer. The addition of panitumumab to the combination of carboplatin and paclitaxel is investigational and currently being used for research purposes only.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to determine the pathologic complete response (pCR) rate in patients with primary triple-receptor negative inflammatory breast cancer (TN-IBC).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have histological confirmation of breast carcinoma (required
  • Have IBC, confirmed according to international consensus criteria (required):
    • a. Onset: Rapid onset of breast erythema, edema, and/or peau d'orange, and/or warm breast, with or without an underlying breast mass
    • b. Duration: History of such findings no more than six months
    • c. Extent: Erythema occupying at least 1/3 of whole breast
    • d. Pathology: Pathologic confirmation of invasive carcinomaHave an ECOG performance status of 0-1 (required)
  • Have negative HER2 expression on IHC (defined as 0 or 1+) or FISH analysis (required) (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%.)
  • Are 18 years of age or older (required)
  • Have LVEF >=50% by multigated acquisition scan (MUGA) or echocardiogram before study randomization
  • Have adequate hematologic function: absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelet count >=100 x 10^9/L, hemoglobin >= 9.0 g/dL
  • Have adequate hepatic function: aspartate aminotransferase (AST) =<3.0 x ULN, alanine aminotransferase (ALT) =< 3.0 x ULN, alkaline phosphatase (ALP) =< 2.5 x ULN, total bilirubin =<1.5 x ULN
  • Have adequate renal function: creatinine (Cr) =< 1.5 mg/dL x ULN, creatinine clearance (CrCl) >= 50 mL/min calculated by the Cockcroft-Gault method as follows: male creatinine clearance = (140 - age in years) x (weight in kg) / (serum Cr x 72); female CrCl = (140 - age in years) x (weight in kg) x 0.85 / (serum Cr x 72).
  • Have the ability and willingness to sign written informed consent
  • If 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

Excluding patients who have:

  • 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
  • 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 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
  • Peripheral neuropathy > grade 1
  • History of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina, or CVA within 6 months of protocol registration
  • History of prior therapy with carboplatin
  • Received a cumulative dose of doxorubicin of greater than 360 mg/m2 or epirubicin of greater than 640 mg/m2
  • Had prior radiotherapy for primary breast carcinoma or axillary lymph nodes
  • History of diagnosed interstitial lung disease