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Breast Cancer Res Treat. 2019 Jul;176(2):303-310. doi: 10.1007/s10549-019-05238-4. Epub 2019 Apr 19.

Local-regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial).

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Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, 450 Brookline Avenue, Boston, MA, USA.
Department of Statistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.
Breast Cancer Medicine Service, Solid Tumor Division, Department of Medicine, Memorial Sloan Kettering Cancer Center and Department of Medicine, Weill Cornell Medical Center, New York, NY, USA.
Department of Medical Oncology, Sarah Cannon Cancer Center, Nashville, TN, USA.
Department of Hematology-Oncology, Massachusetts General Hospital, Boston, MA, USA.
Division of Medical Oncology, Department of Medicine, Duke Cancer Institute, Durham, NC, USA.
Division of Hematology/Oncology, Department of Medicine, Cardinal Bernardin Cancer Center, Loyola University Chicago Stritch School of Medicine, Maywood, IL, USA.
Department of Medicine, Division of Oncology, Helen Diller Comprehensive Cancer Center, University of California, San Francisco, CA, USA.
Department of Medical Oncology, Baylor Clinic-Lester and Sue Smith Breast Center, Houston, TX, USA.
Department of Oncology, Johns Hopkins Kimmel Cancer Center, Baltimore, MD, USA.
Department of Medical Oncology, UNC Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
American Society of Clinical Oncology, Alexandria, VA, USA.



Women with HER2-positive breast cancer treated prior to effective anti-HER2 therapy have higher rates of local-regional recurrence (LRR) than those with HER2-negative disease. Effective systemic therapy, however, has been shown to decrease LRR. This study examines LRR in women with HER2-positive breast cancer treated on a single-arm prospective multicenter trial of adjuvant trastuzumab (H) and paclitaxel (T).


Patients with HER2-positive tumors ≤ 3.0 cm with negative axillary nodes or micrometastatic disease were eligible. Systemic therapy included weekly T and H for 12 weeks followed by continuation of H to complete 1 year. Radiation therapy (RT) was required following breast-conserving surgery (BCS), but dose and fields were not specified. Disease-free survival (DFS) and LRR-free survival were calculated using the Kaplan-Meier method.


Of the 410 patients enrolled from September 2007 to September 2010, 406 initiated protocol therapy and formed the basis of this analysis. A total of 272 (67%) had hormone receptor-positive tumors. Of 162 patients undergoing mastectomy, local therapy records were unavailable for two. None of the 160 for whom records were available received RT. Among 244 BCS patients, detailed RT records were available for 217 (89%). With a median follow-up of 6.5 years, 7-year DFS was 93.3% (95% CI 90.4-96.2), and LRR-free survival was 98.6% (95% CI 97.4-99.8).


LRR in this select group of early-stage patients with HER2-positive disease receiving effective anti-HER2 therapy is extremely low. If confirmed in additional studies, future investigational efforts should focus on de-escalating local therapy.


Breast cancer; HER2; Local regional recurrence; Stage I


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