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Phase II randomized clinical trial evaluating neoadjuvant chemotherapy regimens with weekly paclitaxel or eribulin followed by doxorubicin and cyclophosphamide in women with locally advanced HER2-negative breast cancer: NSABP Foundation Study FB-9

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Abstract

Locally advanced breast cancer (LABC) is a good setting in which to monitor response to neoadjuvant chemotherapy, to downsize the tumor (which facilitates breast-conserving surgery), and to test newer agents in untreated patients. Eribulin (E) has shown activity in patients who have undergone previous taxane, anthracycline, and capecitabine treatment. We aimed to evaluate the neoadjuvant use of E followed by doxorubicin and cyclophosphamide (AC) in patients with HER2-negative LABC, using as a control a randomized group of women who received weekly paclitaxel (WP). Fifty women with LABC were accrued January–August 2013. Patients were randomized (1:2) to receive either WP (N = 19) for 12 treatments or E (N = 31) every 3 weeks for 4 cycles followed by AC every 3 weeks for 4 cycles before surgery. 17/19 patients who took WP and 25/30 who took E completed all cycles. Patients were evaluated by clinical examination and breast MRI at baseline and after completion of E or WP. Surgical pCR in breast and lymph nodes was determined by a local pathologist following chemotherapy. Forty-nine patients received ≥1 dose of neoadjuvant chemotherapy and are included in this analysis. Forty-eight underwent surgery; one had disease that was inoperable (on E) and is included as no-pCR patient. 17/19 of these patients who took WP completed 12 doses; 28/30 on E completed 4 cycles. Six discontinued treatment on WP, E, or AC. Both treatments were well tolerated. pCR on WP = 5/19(26 %) and on E = 5/30(17 %). Both regimens were equally well tolerated with no unexpected toxicities. pCR did not suggest higher activity with E than with other standard regimens in these LABC patients.

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Acknowledgements

This work was supported by Eisai Inc. This work described herein was carried out by the NSABP Foundation and was made possible through a grant from Eisai Inc. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of Eisai.

Conflicts of interest

Antoinette Tan has received research grant(s) from Esai Inc. Marc Buyse is an employee and stockholder of IDDI. All other authors declare no other potential conflict(s) of interest.

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Authors and Affiliations

  1. NSABP Foundation, Inc., Nova Tower 2, Two Allegheny Center, 12th Flr., Pittsburgh, PA, 15212, USA

    Jame Abraham, André Robidoux, Antoinette R. Tan, Steven Limentani, Keren Sturtz, Ibrahim Shalaby, Hope Alcorn, Norman Wolmark & Samuel A. Jacobs

  2. Cleveland Clinic, Taussig Cancer Institute, Cleveland, OH, USA

    Jame Abraham

  3. Centre Hospitalier de l’Université de Montréal, Montréal, QC, Canada

    André Robidoux

  4. Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA

    Antoinette R. Tan

  5. Levine Cancer Institute, Carolinas Health Care System, Charlotte, NC, USA

    Antoinette R. Tan & Steven Limentani

  6. CCOP Colorado Cancer Research Program, Inc., Denver, CO, USA

    Keren Sturtz

  7. Joe Arrington Cancer Research and Treatment Center, Arrington, TX, USA

    Ibrahim Shalaby

  8. International Drug Development Institute (IDDI), Louvain la Neuve, Belgium

    Marc E. Buyse

  9. Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA, USA

    Norman Wolmark

  10. The University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA

    Samuel A. Jacobs

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  1. Jame Abraham
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  2. André Robidoux
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  10. Samuel A. Jacobs
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Corresponding author

Correspondence to Samuel A. Jacobs.

Additional information

Trial Registration: NSABP FB-9: NCT01705691.

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Abraham, J., Robidoux, A., Tan, A.R. et al. Phase II randomized clinical trial evaluating neoadjuvant chemotherapy regimens with weekly paclitaxel or eribulin followed by doxorubicin and cyclophosphamide in women with locally advanced HER2-negative breast cancer: NSABP Foundation Study FB-9. Breast Cancer Res Treat 152, 399–405 (2015). https://doi.org/10.1007/s10549-015-3466-4

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  • DOI: https://doi.org/10.1007/s10549-015-3466-4

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