ArticleBreast cancer research and treatment2017
Development of a Ki-67-based clinical trial assay for neoadjuvant endocrine therapy response monitoring in breast cancer.
Article in Breast cancer research and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 32 citations in OpenAlex.
- Evaluation of Sensitivity to Endocrine Therapy Index (SET2,3) for Response to Neoadjuvant Endocrine Therapy and Longer-Term Breast Cancer Patient Outcomes (Alliance Z1031).Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Trial
- A prospective single-arm pilot study evaluating [F-18]fluoroestradiol dedicated breast PET in invasive lobular carcinoma after neoadjuvant endocrine therapy.Breast cancer research : BCR · 2026Article
- Palbociclib and letrozole for hormone receptor-positive HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy.NPJ breast cancer · 2024Article
- A phase II study of palbociclib plus letrozole plus trastuzumab as neoadjuvant treatment for clinical stages II and III ER+ HER2+ breast cancer (PALTAN).NPJ breast cancer · 2023Article
- Neoadjuvant endocrine therapy in ER-positive breast cancer: evolution, indication, and tailored treatment strategy.Therapeutic advances in medical oncology · 2023Review
- Article
- The prevalence and predictors of adjuvant chemotherapy use among patients treated with neoadjuvant endocrine therapy.Breast cancer research and treatment · 2022Article
- A Pragmatic Machine Learning Approach to Quantify Tumor-Infiltrating Lymphocytes in Whole Slide Images.Cancers · 2022Article
- Review
- Recent advances in neoadjuvant therapy for breast cancer.Faculty reviews · 2021Review
- Breast CancerJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2020Article
- Neoadjuvant endocrine therapy for luminal breast cancer treatment: a first-choice alternative in times of crisis such as the COVID-19 pandemic.Ecancermedicalscience · 2020Article
- Quadruple Negative Breast Cancers (QNBC) Demonstrate Subtype Consistency among Primary and Recurrent or Metastatic Breast Cancer.Translational oncology · 2019Article
- Neoadjuvant Therapy for Breast Cancer as a Model for Translational Research.Breast cancer : basic and clinical research · 2019Review
- Standard Neoadjuvant Treatment in Early/Locally Advanced Breast Cancer.Breast care (Basel, Switzerland) · 2018Review
- Current Status of Neoadjuvant Endocrine Therapy in Early Stage Breast Cancer.Current treatment options in oncology · 2018Review
Corrections and comments
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Authors and funding
14 authors at 6 institutions in 3 countries.
Funding
Abstract
purposeThe recent publication of the ACOSOG Z1031 trial results demonstrated that Ki-67 proliferation marker-based neoadjuvant endocrine therapy response monitoring could be used for tailoring the use of adjuvant chemotherapy in ER+HER2-negative breast cancer patients. In this paper, we describe the development of the Ki-67 clinical trial assay used for this study.
methodsKi-67 assay assessment focused on reproducing a 2.7% Ki-67 cut-point (CP) required for calculating the Preoperative Endocrine Prognostic Index and a 10% CP for poor endocrine therapy response identification within the first month of neoadjuvant endocrine treatment. Image analysis was assessed to increase the efficiency of the scoring process. Clinical outcome concordance for two independent Ki-67 scores was the primary performance metric.
resultsDiscordant scores led to a triage approach where cases with complex histological features that software algorithms could not resolve were flagged for visual point counting (17%). The final Ki-67 scoring approach was run on T1/2 N0 cases from the P024 and POL trials (N = 58). The percent positive agreement for the 2.7% CP was 87.5% (95% CI 61.7-98.5%); percent negative agreement 88.9% (95% CI: 65.3-98.6%). Minor discordance did not affect the ability to predict similar relapse-free outcomes (Log-Rank P = 0.044 and P = 0.055). The data for the 10% early triage CP in the POL trial were similar (N = 66), the percentage positive agreement was 100%, and percent negative agreement 93.55% (95% CI: 78.58-99.21%). The independent survival predictions were concordant (Log-rank P = 0.0001 and P = 0.01).
conclusionsWe have developed an efficient and reproducible Ki-67 scoring system that was approved by the Clinical Trials Evaluation Program for NCI-supported neoadjuvant endocrine therapy trials. Using the methodology described here, investigators are able to identify a subgroup of patients with ER+HER2-negative breast cancer that can be safely managed without the need of adjuvant chemotherapy.
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