Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial

Anna Weiss^{1

2

3

4}, Qingchun Jin⁵, Nabihah Tayob⁵, Eileen Wrabel⁶, Michelle DeMeo⁶, Jamie Carter⁶, Michael Constantine^{6

7

8}, Meredith Faggen^{6

7

8}, Caroline Block^{6

7

8}, Mary Anne Fenton⁹, K M Steve Lo¹⁰, Thomas Openshaw¹¹, Denise Yardley¹², Laura Kennedy¹³, Isabelle Bedrosian¹⁴, Elizabeth A Mittendorf^{15

6

7}, Rinath Jeselsohn^{6

7

8}, Otto Metzger Filho^{6

7

8}, Tari A King^{15

6

7

16}

Affiliations

¹ Division of Surgical Oncology, Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA. Anna_weiss@urmc.rochester.edu.
² Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA. Anna_weiss@urmc.rochester.edu.
³ Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA. Anna_weiss@urmc.rochester.edu.
⁴ Harvard Medical School, Boston, MA, USA. Anna_weiss@urmc.rochester.edu.
⁵ Department of Data Science, Dana-Farber Cancer Institute, Boston, MA, USA.
⁶ Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
⁷ Harvard Medical School, Boston, MA, USA.
⁸ Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
⁹ Division of Oncology, Lifespan Cancer Institute, Providence, RI, USA.
¹⁰ Division of Medical Oncology, Stamford Health, Stamford, CT, USA.
¹¹ Eastern Maine Medical Center, Bangor, ME, USA.
¹² Department of Medical Oncology, Sarah Cannon Research Institute, Nashville, TN, USA.
¹³ Division of Medical Oncology, Vanderbilt University Medical Center, Nashville, TN, USA.
¹⁴ Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁵ Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.
¹⁶ Winship Cancer Institute of Emory University, Atlanta, GA, USA.

PMID: 41276768
DOI: 10.1245/s10434-025-18697-5

Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial

Anna Weiss et al. Ann Surg Oncol. 2025.

. 2025 Nov 23.

doi: 10.1245/s10434-025-18697-5. Online ahead of print.

Authors

Affiliations

¹ Division of Surgical Oncology, Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA. Anna_weiss@urmc.rochester.edu.
² Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA. Anna_weiss@urmc.rochester.edu.
³ Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA. Anna_weiss@urmc.rochester.edu.
⁴ Harvard Medical School, Boston, MA, USA. Anna_weiss@urmc.rochester.edu.
⁵ Department of Data Science, Dana-Farber Cancer Institute, Boston, MA, USA.
⁶ Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA.
⁷ Harvard Medical School, Boston, MA, USA.
⁸ Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
⁹ Division of Oncology, Lifespan Cancer Institute, Providence, RI, USA.
¹⁰ Division of Medical Oncology, Stamford Health, Stamford, CT, USA.
¹¹ Eastern Maine Medical Center, Bangor, ME, USA.
¹² Department of Medical Oncology, Sarah Cannon Research Institute, Nashville, TN, USA.
¹³ Division of Medical Oncology, Vanderbilt University Medical Center, Nashville, TN, USA.
¹⁴ Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁵ Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.
¹⁶ Winship Cancer Institute of Emory University, Atlanta, GA, USA.

PMID: 41276768
DOI: 10.1245/s10434-025-18697-5

Abstract

Background: Data to inform surgical management of the axilla after neoadjuvant endocrine therapy (NET) are limited. Here we report nodal status, surgical procedure, and outcomes among patients enrolled between 2016 and 2020 in the Palbociclib and Endocrine therapy for LObular breast cancer Preoperative Study (NCT02764541).

Methods: Women with hormone receptor-positive, HER2-negative tumors > 1.5 cm, any cN, were randomized 2:1 to NET ± palbociclib for 24 weeks. Axillary surgery (sentinel lymph node biopsy [SLNB] ± axillary dissection [ALND]) and nodal evaluation (H&E ± IHC) were not specified in the protocol. Pathologic node-positive (ypN+) rates, local-regional recurrence-free interval (LRRFI), and breast cancer-specific survival (BCSS), compared by univariate Cox proportional hazards, were prespecified exploratory endpoints.

Results: A total of 188 patients were analyzed (128 treated with NET + palbociclib, 60 NET), median age 56.5 years (interquartile range [IQR] 50-66). 82 (43.6%) had lobular histology, 99 (52.7%) were cN0, 84 (44.7%) cN+, and 5 (2.6%) cN unknown. Of cN+ patients with known ypN, nodal pathologic complete response rates were 10.9% (6/55) after NET + palbociclib and 13.6% (3/22) after NET. Among 108 ypN+ patients, 26 (24.1%) underwent SLNB, 82 (75.9%) ALND, and 99 (91.7%) radiation. At 4.65 years (IQR 3.66-5.56) median follow-up, 3-year LRRFI for ypN+ patients treated with SLNB only was 96% (88.6%, 100%) and ALND was 97.4% (93.9%, 100.0%), p = 0.6; 3-year BCSS for SLNB was 96.0% (88.6%, 100.0%) and ALND was 100.0% (100%, 100%), p = 0.9.

Conclusions: The addition of palbociclib to NET did not impact pathologic nodal outcomes. Among those with ypN+ disease, neither LRRFI nor BCSS appears to be impacted by performance of ALND.

Trial registration: clinicaltrials.gov, NCT02764541.

Keywords: Axillary lymph node dissection; Axillary management; Axillary surgery; Breast cancer; Clinical trial; Neoadjuvant endocrine therapy; Outcomes.

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Conflict of interest statement

Disclosure: AW reports paid advisory board participation for Abbvie, Merck, and Myriad. She has received honoraria from OncLive (MJH Lifesciences), Empire State Hematology & Oncology Society, Society of Breast Imaging. EAM reports compensated service on scientific advisory boards for AstraZeneca, BioNTech, Merck and Moderna; uncompensated service on steering committees for Bristol Myers Squibb and Roche/Genentech; speakers honoraria and travel support from Merck Sharp & Dohme; and institutional research support from Roche/Genentech (via SU2C grant) and Gilead. EAM also reports research funding from Susan Komen for the Cure for which she serves as a Scientific Advisor, and uncompensated participation as a member of the American Society of Clinical Oncology Board of Directors. OM-F reports research support from Pfizer to institution. TAK reports speaker honoraria for Exact Sciences, compensated service on the FES Steering Committee for GE Healthcare, compensated service for advisory board role for Veracyte, and compensated service as faculty for PrecisCa cancer information service. RJ reports funding from Pfizer for the PELOPS clinical trial; consulting fees from Pfizer, Novartis, Astra Zeneca, Lilly, Carrick Therapeutics; and research funding from Novartis, Lilly, Recursion and Pfizer (institutional funding).

References

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Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial

Affiliations

Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial

Authors

Affiliations

Abstract

Conflict of interest statement

References

Associated data

LinkOut - more resources

Full Text Sources

Medical

Research Materials

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