Active — Not RecruitingPhase 2

Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer

United States88 participantsStarted 2014-01-30

Plain-language summary

This research is being done to determine if early changes on a type of imaging procedure called PET (Positron Emission Tomography) can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Absolute neutrophil count (ANC) ≥ 1,500/mm3
✓. Platelet count ≥ 100,000/mm3
✓. Hemoglobin ≥ 10 g/dL
✓. Creatinine ≤ 1.5 times the upper limit of normal with creatinine clearance ≥ 50 mL/min using the Modified Cockcroft-Gault method
✓. Bilirubin (total) ≤ 1.5 times upper limit normal (with exception of Gilberts syndrome)
✓. AST(SGOT), ALT(SGPT), and alkaline phosphatase ≤ 2 times the upper limit of normal

What they're measuring

Percent Change in Standardized Uptake Value (SUV) as Measured by SULmax on [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)

Timeframe: Baseline and Day 15

Trial details

NCT IDNCT01937117

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-20

Results submitted2019-03-18

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