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Original Investigation
January 8, 2020

Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial

Author Affiliations
  • 1Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Boston, Massachusetts
  • 2Department of Medical Oncology, German Breast Group, Neu-Isenburg, Germany
  • 3Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada
  • 4Department of Medical Oncology, University of Ulm, Ulm, Germany
  • 5Department of Medical Oncology, Texas Oncology–Baylor Sammons Cancer Center, US Oncology, Dallas
  • 6Department of Medical Oncology, University of California, San Francisco
  • 7Department of Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania
  • 8AbbVie, Inc, North Chicago, Illinois
  • 9Department of Medical Oncology, Virginia Commonwealth University Massey Cancer Center, Richmond
  • 10Department of Medical Oncology, Women and Infants Hospital of Rhode Island, Providence
  • 11Department of Breast Surgery, Helios Klinikum Berlin-Buch, Berlin, Germany
JAMA Surg. Published online January 8, 2020. doi:10.1001/jamasurg.2019.5410
Key Points

Question  How often does neoadjuvant systemic therapy facilitate breast conservation in women with triple-negative breast cancer?

Findings  This prespecified secondary analysis of a randomized clinical trial of 604 women with stages II to III triple-negative breast cancer demonstrates that neoadjuvant systemic therapy made breast conservation possible in 53.2% of patients who would have otherwise required mastectomy, increasing the percentage of those eligible for breast conservation from 76.5% at diagnosis to 83.8%. Rates of pathologic complete response were similar between patients deemed eligible for breast conservation before and those who converted to eligibility after neoadjuvant systemic therapy.

Meaning  Based on these findings, women with triple-negative breast cancer who are not candidates for breast conservation at presentation should be counselled that there is a 50% likelihood they will become candidates after neoadjuvant systemic therapy.

Abstract

Importance  Neoadjuvant systemic therapy (NST) is often administered to enable breast-conserving therapy (BCT) in stages II to III breast cancer.

Objectives  To prospectively evaluate the role of NST in conversion from BCT ineligibility to BCT eligibility and to assess the association of response to NST, germline BRCA (gBRCA) status, and region of treatment with surgical choice in women with triple-negative breast cancer (TNBC).

Design, Setting, and Participants  This prespecified secondary analysis of a multicentered, phase 3, double-blind, randomized clinical trial (BrighTNess) enrolled 634 eligible women across 145 centers in 15 countries in North America, Europe, and Asia. Women with operable, clinical stages II to III TNBC who underwent gBRCA mutation testing before initiating NST were eligible to participate. Data were collected from April 1, 2014, to December 8, 2016. This preplanned analysis was performed from January 5, 2018, to October 28, 2019.

Interventions  Study participants were randomized to receive 12 weeks of weekly paclitaxel alone or with the addition of carboplatin and/or veliparib, followed by 4 cycles of doxorubicin hydrochloride and cyclophosphamide.

Main Outcomes and Measures  Surgeons assessed BCT candidacy by clinical and radiographic criteria before and after NST. Surgical choices and whether BCT eligibility was associated with the likelihood of pathologic complete response were then analyzed.

Results  Among the 634 randomized patients (median age, 51 [range, 22-78] years), pre- and post-NST assessments were available for 604 patients. Of 141 patients deemed BCT ineligible at baseline, 75 (53.2%) converted to BCT eligible. Overall, 342 (68.1%) of 502 patients deemed BCT eligible after NST underwent BCT, including 42 (56.0%) of the 75 who converted to BCT eligible. Patients treated in Europe and Asia were more likely to undergo BCT (odds ratio, 2.66; 95% CI, 1.84-3.84) compared with those treated in North America. Among patients without gBRCA mutation undergoing mastectomy, those treated in North America were more likely to undergo contralateral prophylactic mastectomy (57 of 81 [70.4%] vs 6 of 30 [20.0%]; P < .001). Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).

Conclusions and Relevance  This prospective analysis of NST and BCT eligibility in TNBC demonstrates a conversion from BCT ineligibility to BCT eligibility of 53.2%. Lower BCT rates among eligible patients and higher bilateral mastectomy rates among patients without gBRCA mutation in North America merit investigation.

Trial Registration  ClinicalTrials.gov identifier: NCT02032277

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