A Phase I Study of Neoadjuvant Chemotherapy With Nab-Paclitaxel, Doxorubicin, and Cyclophosphamide in Patients With Stage II to III Breast Cancer

Theresa L. Werner, Abhijit Ray, John G. Lamb, Matthew VanBrocklin, Kristin Hueftle, Adam L. Cohen, Anna C. Beck, Saundra S. Buys, Donna L. Dyess, Thomas W. Butler, Theresa L. Dumlao, Leigh Neumayer, Hung T. Khong

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


We investigated a novel combinatorial approach using old drugs doxorubicin, cyclophosphamide and nab-paclitaxel in the neoadjuvant setting. Patients were enrolled in Alabama and Utah in a standard 3+3 phase I design. The clinical response rate was 100%; the pathologic complete response (pCR) was over 56%. All 10 patients with triple negative disease (TNBC) achieved pCR (100%). Toxicities were as expected for chemotherapy. This approach warrants further studies in TNBC. Background The aims of this study were to assess the safety and tolerability of nanoparticle albumin bound paclitaxel (nab-paclitaxel), doxorubicin, and cyclophosphamide as combination therapy for breast cancer patients in the neoadjuvant setting and to assess the overall clinical response and pathologic complete response (pCR). Patients and Methods Twenty-six women with newly diagnosed stage II to III histologically or cytologically proven adenocarcinoma of the breast with negative HER2 status were enrolled. Patients were treated with nab-paclitaxel 100 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2 on day 1 and nab-paclitaxel 100 mg/m2 on day 8 in a 21-day cycle for 6 cycles total. Results Most adverse events attributed to treatment were decreased white blood cell count, neutropenia, anemia, thrombocytopenia, and lymphopenia with a median duration of 8 days. Fifteen of 23 (65.2%; 95% confidence interval [CI], 45.7%-84.6%) had a complete clinical response and 8 of 23 (34.7%; 95% CI, 15.2%-54.1%) had a partial clinical response for an overall clinical response rate of 100%. Thirteen of 23 patients (56.5%; 95% CI, 36.2%-76.7%) had a pCR. All 10 triple-negative breast cancer (TNBC) patients (100%) achieved a pCR. Conclusion The regimen of nab-paclitaxel, doxorubicin, and cyclophosphamide chemotherapy was well tolerated and resulted in high clinical as well as pathologic responses, particularly in TNBC.

Original languageEnglish (US)
Pages (from-to)503-509
Number of pages7
JournalClinical Breast Cancer
Issue number7
StatePublished - Nov 2017


  • Estrogen receptor
  • Pathologic complete response (pCR)
  • Triple-negative breast cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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