Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint

and I-SPY 2 Investigators

Research output: Contribution to journalReview articlepeer-review

15 Scopus citations


Advances in the surgical management of the axilla in patients treated with neoadjuvant chemotherapy, especially those with node positive disease at diagnosis, have led to changes in practice and more judicious use of axillary lymph node dissection that may minimize morbidity from surgery. However, there is still significant confusion about how to optimally manage the axilla, resulting in variation among practices. From the viewpoint of drug development, assessment of response to neoadjuvant chemotherapy remains paramount and appropriate assessment of residual disease—the primary endpoint of many drug therapy trials in the neoadjuvant setting—is critical. Therefore decreasing the variability, especially in a multicenter clinical trial setting, and establishing a minimum standard to ensure consistency in clinical trial data, without mandating axillary lymph node dissection, for all patients is necessary. The key elements which include proper staging and identification of nodal involvement at diagnosis, and appropriately targeted management of the axilla at the time of surgical resection are presented. The following protocols have been adopted as standard procedure by the I-SPY2 trial for management of axilla in patients with node positive disease, and present a framework for prospective clinical trials and practice.

Original languageEnglish (US)
Article number26
Journalnpj Breast Cancer
Issue number1
StatePublished - Dec 1 2018

Bibliographical note

Funding Information:
The authors thank Anna Barker for leadership in helping to launch the I-SPY 2 TRIAL; the members of the data and safety monitoring committee (Harold Burstein, Elizabeth Frank, Steven Goodman, Clifford Hudis, Robert Mass, Musa Meyer, and Janet Wittes) for meeting monthly to review the safety data; the trial coordinators; Ken Buetow and the staff of caBIG for input with the informatics design; the entire project oversight committee; and our patient advocates, and investigators. The authors would like to extend our gratitude to all the patients who volunteered to participate in I-SPY2. I-SPY2 is supported by QuantumLeap Healthcare Collaborative (2013 to present) and the Foundation for the National Institutes of Health (2010 to 2012) and by a grant (28XS197) from the National Cancer Institute Center for Biomedical Informatics and Information Technology. The authors sincerely appreciate the ongoing support for the I-SPY 2 TRIAL from the Safeway Foundation, the Bill Bowes Foundation and Give Breast Cancer the Boot. Initial support was provided by Quintiles Transnational Corporation, Johnson & Johnson, Genentech, Amgen, the San Francisco Foundation, Eli Lilly, Pfizer, Eisai Company, Side Out Foundation, Harlan Family, the Avon Foundation for Women, Alexandria Real Estate Equities, and private individuals and family foundations.

Publisher Copyright:
© 2018, The Author(s).


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