Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms
Intervention: Panitumumab; Nab-paclitaxel; Carboplatin; 5-Fluorouracil; Epirubicin; Cyclophosphamide
Intervention description: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.; 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.; AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.; 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).; 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).; 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Cyclophosphamide; Carboplatin; Fluorouracil; Epirubicin; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Inflammatory Breast Cancer; IBC; Primary breast carcinoma; HER2 negative overexpression; Panitumumab; Vectibix; Nab-paclitaxel; Paclitaxel; Abraxane; Carboplatin; Paraplatin; PNC; 5-fluorouracil; 5-FU; Adrucil; Efudex; Epirubicin; Ellence; Cyclophosphamide; Cytoxan; Neosar; FEC

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological confirmation of breast carcinoma. Pathologic evidence of dermal lymphatic
             invasion should be noted but not required.

          2. Clinical diagnosis of IBC (presence of inflammatory changes in the involved breast,
             including diffuse erythema, heat, ridging, and peau d'orange).

          3. >/= Age 18

          4. ECOG performance status </= 1

          5. Adequate hematologic function: Absolute neutrophil count (ANC) >/= 1.5 x 109/L,
             Platelet count >/= 100 x 109/L, Hemoglobin >/= 9.0 g/dL

          6. Adequate cardiac function (LVEF >/= 45%)

          7. 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)

          8. 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

          9. Ability and willingness to sign an informed consent form for this protocol

         10. If female of childbearing potential (women who are post-menopausal < 1 year, not
             surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees
             to be consistent and correct use of one of the following acceptable methods of birth
             control: male partner who is sterile prior to the female subject entry into the study
             and is the sole sexual partner for that female subject; any intrauterine device (IUD)
             with a documented failure rate of less than 1% per year; oral contraception, or
             barrier methods, including diaphragm or condom with a spermicide.

         11. Patients who have metastatic disease, if the metastatic sites are amendable for local
             therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be
             eligible,

        Exclusion Criteria:

          1. History of radiation or chemotherapy

          2. HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification
             by FISH)

          3. Recurrent breast cancer

          4. 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)

          5. Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus,
             acute or chronic active hepatitis B infection

          6. 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

          7. Patient with other significant medical or psychiatric condition that would make
             assessment of toxicity or efficacy difficult.

          8. 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.

          9. Peripheral neuropathy >= Gr II