Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer (NCT01036087) | Clinical Trial Compass
CompletedPhase 2
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
United States47 participantsStarted 2010-11
Plain-language summary
The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. The safety of PNC combination will also be studied.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histological confirmation of breast carcinoma. Pathologic evidence of dermal lymphatic invasion should be noted but not required.
✓. Clinical diagnosis of IBC (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).
✓. 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) x (weight in Kg) / (serum Cr x 72) Female CrCl = (140 - age) x (weight in Kg) x 0.85 / (serum Cr x 72)
✓. Adequate Hepatic function: Aspartate aminotransferase (AST) \</= 2.5 x ULN • Alanine aminotransferase (ALT) \</= 2.5 x ULN • Alkaline phosphatase (Alp) \</= 2.5 x ULN.Total bilirubin \</=1.5 x ULN
Exclusion criteria
✕. History of radiation or chemotherapy
✕. HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by FISH)
✕. Recurrent breast cancer
What they're measuring
1
Number of Participants That Achieved Pathologic Complete Response (CR)
Timeframe: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
. History of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for \>5 years)
✕. 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
✕. Patient with 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.