Phase 2
Completed N=40
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
Source: ClinicalTrials.gov NCT01036087 ↗Enrolled (actual)
40
Serious AEs
37.5%
Results posted
Sep 2022
Primary outcomePrimary: Number of Participants That Achieved Pathologic Complete Response (CR) — 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Achieved Pathologic Complete Response (CR) |
11 | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events (AEs) |
36; 26 | — |
Eligibility Criteria
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).
- >/= Age 18
- ECOG performance status /= 1.5 x 109/L, Platelet count >/= 100 x 109/L, Hemoglobin >/= 9.0 g/dL
- Adequate cardiac function (LVEF >/= 45%)
- Adequate Renal function: Creatinine (Cr) /= 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) 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.
- Peripheral neuropathy >= Gr II
Data sourced from ClinicalTrials.gov (NCT01036087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.