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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).
. 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
. 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.