NCI / NIH Neoadjuvant Drug Protocol



National Cancer Institiute (NCI)
National Institute of Health (NIH)
United States Government


Neoadjuvant Treatment of HER2-positive Breast Cancer

“On September 30, 2013, the Food and Drug Administration (FDA) granted accelerated approval to pertuzumab injection (Perjeta®, made by Genentech, Inc.) for use in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.”

“Pertuzumab should be administered every 3 weeks for 3 to 6 cycles as part of one of the following treatment regimens for early breast cancer:
  1. Four preoperative cycles of pertuzumab in combination with trastuzumab and docetaxel, followed by 3 postoperative cycles of FEC; 1/
  2. Three preoperative cycles of FEC alone, followed by 3 preoperative cycles of pertuzumab in combination with docetaxel and trastuzumab; or
  3. Six preoperative cycles of pertuzumab in combination with docetaxel, carboplatin and trastuzumab.”

“Following surgery, patients should continue to receive trastuzumab to complete 1 year of treatment.”

“There is insufficient evidence to recommend continued use of pertuzumab for greater than 6 cycles for early breast cancer. There is insufficient evidence to recommend concomitant administration of an anthracycline with pertuzumab, and there are no safety data to support sequential use of doxorubicin with pertuzumab.”


1/ In clinical trials:

  • “Pertuzumab, trastuzumab, and docetaxel were administered preoperatively by intravenous infusion (IV) every 3 weeks for a total of 4 cycles. Following surgery all patients received 3 cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) IV every 3 weeks and trastuzumab was administered IV every 3 weeks to complete 1 year of therapy.”
  • “The trial’s primary endpoint was pathologic complete response (pCR) rate defined as the absence of invasive cancer in the breast (ypT0/is). The FDA-preferred definition of pCR is the absence of invasive cancer in the breast and lymph nodes (ypT0/is ypN0).”
  • “The pCR (ypT0/is ypN0) rates were 39.3 percent in patients who received pertuzumab plus trastuzumab and docetaxel and 21.5 percent in patients who received trastuzumab plus docetaxel. This difference of 17.8 percent was statistically significant (adjusted p-value = 0.0063, Cochran-Mantel-Haenszel test).”
  • “The pCR rates and magnitude of improvement with the addition of pertuzumab were lower in the subgroup of patients with hormone receptor-positive tumors compared to patients with hormone receptor-negative tumors.”
  • “The recommended dose and schedule of pertuzumab is an initial dose of 840 mg administered IV as a 60 minute infusion followed every 3 weeks by 420 mg administered IV as a 30- to 60-minute infusion. “

Source(s): www.cancer.gov, National Cancer Institute (NCI) – National Institute of Health (NIH), Updated: 10/01/2013


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