Clinical trial · Interventional
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression
NCT01036087CI-TRIAL-00065187completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Panitumumab | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PNC + FEC
- description
- PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and FEC = 5-fluorouracil, epirubicin, and cyclophosphamide
- interventionNames
- Drug: Panitumumab
- Drug: Nab-paclitaxel
- Drug: Carboplatin
- Drug: 5-Fluorouracil
- Drug: Epirubicin
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Number of Participants That Achieved Pathologic Complete Response (CR)
- timeFrame
- Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
- description
- Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMatsuda N, Wang X, Lim B, Krishnamurthy S, Alvarez RH, Willey JS, Parker CA, Song J, Shen Y, Hu J, Wu W, Li N, Babiera GV, Murray JL, Arun BK, Brewster AM, Reuben JM, Stauder MC, Barnett CM, Woodward WA, Le-Petross HTC, Lucci A, DeSnyder SM, Tripathy D, Valero V, Ueno NT. Safety and Efficacy of Panitumumab Plus Neoadjuvant Chemotherapy in Patients With Primary HER2-Negative Inflammatory Breast Cancer. JAMA Oncol. 2018 Sep 1;4(9):1207-1213. doi: 10.1001/jamaoncol.2018.1436. PMID 29879283