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 range18 Years
SexALL
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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
*…
What they're measuring
1
Complete pathologic response
Timeframe: At the time of surgery, assessed up to 5 years