Breast Cancer Research and Treatment

, Volume 123, Issue 2, pp 471–475 | Cite as

A pilot study of adjuvant nanoparticle albumin-bound (nab) paclitaxel and cyclophosphamide, with trastuzumab in HER2-positive patients, in the treatment of early-stage breast cancer

  • Denise Yardley
  • Howard BurrisIII
  • Nancy Peacock
  • Eric Raefsky
  • Marianne Melnik
  • Roger Inhorn
  • Dianna Shipley
  • John Hainsworth
Clinical trial

Abstract

nab-Paclitaxel has shown favorable efficacy and toxicity profiles compared to other taxanes in the treatment of metastatic breast cancer. In this pilot trial, we evaluated a nab-paclitaxel-containing adjuvant regimen in patients with early stage breast cancer. Patients with node-positive or high-risk node-negative early-stage breast cancer were eligible following completion of standard primary therapy. All the patients received four cycles, at 21-day intervals, of nab-paclitaxel (100 mg/m2 IV days 1, 8, and 15) and cyclophosphamide (600 mg/m2 IV day 1). HER2-positive patients also received trastuzumab 8 mg/kg IV on cycle 1 day 1, followed by 6 mg/kg every 21 days for a total of 52 weeks. The purpose of this trial was to evaluate feasibility and toxicity of this nab-paclitaxel-containing adjuvant regimen. 62 patients were treated between 2/08 and 11/08. The majority of the patients (87%) were HER2-negative. This adjuvant regimen was well tolerated, and full doses of all agents were administered in >90% of cycles. Grade 3/4 neutropenia occurred in 53% of the patients; however, only one episode of febrile neutropenia occurred in a total of 249 cycles administered. Other grade 3/4 adverse events occurred in less than 5% of patients. After short follow-up, all the patients remain alive and disease-free. The combination of nab-paclitaxel and cyclophosphamide, with or without trastuzumab, is feasible and well tolerated in patients with early stage breast cancer. Further investigation of the role of nab-paclitaxel in adjuvant breast cancer therapy is indicated, but definitive evaluation will require randomized phase III trials.

Keywords

Adjuvant Nab-paclitaxel Cyclophosphamide Trastuzumab HER2-positive Early stage breast cancer 

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Copyright information

© Springer Science+Business Media, LLC. 2010

Authors and Affiliations

  • Denise Yardley
    • 1
    • 2
  • Howard BurrisIII
    • 1
    • 2
  • Nancy Peacock
    • 2
  • Eric Raefsky
    • 2
  • Marianne Melnik
    • 3
  • Roger Inhorn
    • 4
  • Dianna Shipley
    • 2
  • John Hainsworth
    • 1
    • 2
  1. 1.Sarah Cannon Research InstituteNashvilleUSA
  2. 2.Tennessee OncologyPLLCNashvilleUSA
  3. 3.Grand Rapids Clinical Oncology Program Grand RapidsGrand RapidsUSA
  4. 4.Mercy Hospital PortlandPortlandUSA

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