Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple … (NCT02876107) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer
United States42 participantsStarted 2016-10-06
Plain-language summary
This randomized phase II trial studies how well carboplatin and paclitaxel with or without panitumumab work in treating patients with invasive triple negative breast cancer. Drugs used in the chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping the them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Giving carboplatin and paclitaxel with or without panitumumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
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:
* Patients must have histological confirmation of breast carcinoma
* Patients must have invasive breast cancer (IBC), confirmed according to international consensus criteria:
* Onset: Rapid onset of breast erythema, edema, and/or peau d'orange, and/or warm breast, with or without an underlying breast mass
* Duration: History of such findings no more than 6 months
* Extent: Erythema occupying at least 1/3 of whole breast
* Pathology: Pathologic confirmation of invasive carcinoma
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Patients must have negative HER2 expression on immunohistochemistry (IHC) (defined as 0 or 1+) or fluorescence in situ hybridization (FISH) analysis; if HER2 is 2+, negative HER2 expression must be confirmed by FISH (HER2/cep17 ration \< 2, and/or copy number less than 6); ER and PgR expression should be less than 10%
* Patients have left ventricular ejection fraction (LVEF) \>= 50% by multigated acquisition scan (MUGA) or echocardiogram before study randomization
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Platelet count \>= 100 x 10\^9/L
* Hemoglobin \>= 9.0 g/dL
* Aspartate aminotransferase (AST) =\< 3.0 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) =\< 3.0 x ULN
* Alkaline phosphatase (ALP) =\< 2.5 x ULN
* Total bilirubin =\< 1.5 x ULN
* Creatinine (Cr) =\< 1.5 mg/dL x ULN
* Creatinine clearance (CrCl) \>= 50 mL/min calculated by the Cockroft-Gault
*…
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.
1This trial is testing whether adding panitumumab to carboplatin and paclitaxel improves complete pathologic response in triple-negative breast cancer — can you explain what 'complete pathologic response' means for my specific situation and why it matters as a goal?
2Since this is a Phase 2 trial, what is still unknown about the safety and effectiveness of adding panitumumab to chemotherapy, and how does that uncertainty compare to standard treatment options I might consider first?
3The trial is no longer enrolling new patients but is still active — does that mean results might be available soon, and could those findings influence the treatment approach you'd recommend for me right now?
4Panitumumab targets the EGFR pathway — do you know whether my tumor has been tested for EGFR expression, and would that affect whether this kind of combination therapy might be relevant to my care?
5Given that this trial involves both carboplatin and paclitaxel plus a potential third drug, how would the demands of that regimen — in terms of side effects and visit frequency — fit with my current health and daily life compared to other treatment paths?
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
Complete pathologic response
Timeframe: At the time of surgery, assessed up to 5 years