Phase 2
N=40
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01036087 ↗Enrolled (actual)
40
Serious AEs
37.5%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants That Achieved Pathologic Complete Response (CR) — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Panitumumab (Drug); Nab-paclitaxel (Drug); Carboplatin (Drug); 5-Fluorouracil (Drug); Epirubicin (Drug); Cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2016
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 | — |
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
- 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.