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Breast Cancer Research and Treatment
Published in: Breast Cancer Research and Treatment 3/2020

01-04-2020 | Breast Cancer | Clinical trial

Phase II trial of eribulin in patients who do not achieve pathologic complete response (pCR) following neoadjuvant chemotherapy

Authors: Denise A. Yardley, Nancy Peacock, Brooke Daniel, Betrand Anz, David C. Molthrop Jr, Sonalee K. Shroff, Robyn Young, Aleksander Jankov, Amy Vander Woude, Mythili Shastry, Johanna Pasek, Laura M. DeBusk, John D. Hainsworth

Published in: Breast Cancer Research and Treatment | Issue 3/2020

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Abstract

Purpose

Women with residual invasive breast cancer at the primary site or axillary lymph nodes following neoadjuvant chemotherapy have a high risk of recurrence. Eribulin improves survival in patients with metastatic breast cancer who progress after anthracycline and taxane therapy. This phase 2 trial assessed the efficacy of postoperative eribulin in breast cancer patients who did not achieve a pCR following standard neoadjuvant chemotherapy.

Methods

Women with localized breast cancer who had residual invasive cancer following ≥ 4 cycles of standard anthracycline and/or taxane-containing neoadjuvant chemotherapy received adjuvant eribulin treatment. HER2-positive patients also received trastuzumab for 1 year. Adjuvant hormonal therapy and locoregional radiotherapy were administered as per institutional guidelines. Primary endpoint was the 2-year DFS rate. Three patient cohorts were analyzed: TNBC (Cohort A), HR+/HER2− (Cohort B), and HER2+ (Cohort C).

Results

One hundred twenty-six patients (Cohort A-53, Cohort B-42, and Cohort C-31) were enrolled. Neoadjuvant chemotherapy included a taxane and an anthracycline in 70%. Eribulin was well tolerated; 84% of patients received the planned 6 cycles. After a median follow-up of 28 months, the 24-month DFS rates were 56% (95% CI 42, 69), 83% (95% CI 67, 91), and 73% (95% CI 53, 86) for Cohorts A, B, and C, respectively. The most common grade 3/4 treatment-related adverse events were neutropenia (26%), leukopenia (13%), and neuropathy (7%).

Conclusion

Administration of adjuvant eribulin after neoadjuvant chemotherapy was feasible and well tolerated. The 24-month DFS rate did not reach the study target levels in any of the cohorts and was similar to DFS previously described in these cohorts following neoadjuvant chemotherapy alone.
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Metadata
Title
Phase II trial of eribulin in patients who do not achieve pathologic complete response (pCR) following neoadjuvant chemotherapy
Authors
Denise A. Yardley
Nancy Peacock
Brooke Daniel
Betrand Anz
David C. Molthrop Jr
Sonalee K. Shroff
Robyn Young
Aleksander Jankov
Amy Vander Woude
Mythili Shastry
Johanna Pasek
Laura M. DeBusk
John D. Hainsworth
Publication date
01-04-2020
Publisher
Springer US
Published in
Breast Cancer Research and Treatment / Issue 3/2020
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI
https://doi.org/10.1007/s10549-020-05563-z

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