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Purpose: To update recommendations on appropriate use of breast cancer biomarker assay results to guide adjuvant endocrine and chemotherapy decisions in early-stage breast cancer., Methods: An updated literature search identified randomized clinical trials and prospective-retrospective studies published from January 2016 to October 2021. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert Panel members used informal consensus to develop evidence-based recommendations., Results: The search identified 24 studies informing the evidence base., Recommendations: Clinicians may use Onco type DX, MammaPrint, Breast Cancer Index (BCI), and EndoPredict to guide adjuvant endocrine and chemotherapy in patients who are postmenopausal or age > 50 years with early-stage estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative (ER+ and HER2-) breast cancer that is node-negative or with 1-3 positive nodes. Prosigna and BCI may be used in postmenopausal patients with node-negative ER+ and HER2- breast cancer. In premenopausal patients, clinicians may use Onco type in patients with node-negative ER+ and HER2- breast cancer. Current data suggest that premenopausal patients with 1-3 positive nodes benefit from chemotherapy regardless of genomic assay result. There are no data on use of genomic tests to guide adjuvant chemotherapy in patients with ≥ 4 positive nodes. Ki67 combined with other parameters or immunohistochemistry 4 score may be used in postmenopausal patients without access to genomic tests to guide adjuvant therapy decisions. BCI may be offered to patients with 0-3 positive nodes who received 5 years of endocrine therapy without evidence of recurrence to guide decisions about extended endocrine therapy. None of the assays are recommended for treatment guidance in individuals with HER2-positive or triple-negative breast cancer. Treatment decisions should also consider disease stage, comorbidities, and patient preferences.Additional information is available at www.asco.org/breast-cancer-guidelines., Competing Interests: Fabrice AndreStock and Other Ownership Interests: PegacsyResearch Funding: AstraZeneca (Inst), Novartis (Inst), Pfizer (Inst), Lilly (Inst), Roche (Inst), Daiichi (Inst).Travel, Accommodations, Expenses: Novartis, Roche, GlaxoSmithKline, AstraZeneca Nofisat IsmailaEmployment: GlaxoSmithKline (I)Stock and Other Ownership Interests: GlaxoSmithKline (I) Kimberly H. AllisonConsulting or Advisory Role: MammotomeExpert Testimony: Kaiser Permanente William E. BarlowResearch Funding: Merck (Inst), AstraZeneca (Inst). Deborah E. CollyarHonoraria: PfizerConsulting or Advisory Role: Parexel, MaxisIT, Kinnate BiopharmaTravel, Accommodations, Expenses: Parexel Senthil DamodaranResearch Funding: EMD Serono (Inst), Guardant Health (Inst), Taiho Pharmaceutical (Inst), Novartis (Inst), Sermonix Pharmaceuticals (Inst) N. Lynn HenryResearch Funding: Blue Note Therapeutics (Inst)Open Payments Link: https://openpaymentsdata.cms.gov/physician/27894/summary Komal JhaveriConsulting or Advisory Role: Novartis, Pfizer, AstraZeneca, Jounce Therapeutics, Synthon, Intellisphere, Bristol Myers Squibb, Genentech, AbbVie, Lilly, BluePrint Medicines, Seattle Genetics, Daiichi Sankyo, Biotheranostics, SunPharma Pvt Ltd, Taiho Oncology, SanofiResearch Funding: Novartis (Inst), Genentech (Inst), Debiopharm Group (Inst), ADC Therapeutics (Inst), Pfizer (Inst), Novita Pharmaceuticals (Inst), Clovis Oncology (Inst), Lilly (Inst), Zymeworks (Inst), Immunomedics (Inst), Puma Biotechnology (Inst), VelosBio/Merck (Inst), AstraZeneca (Inst)Travel, Accommodations, Expenses: Taiho Pharmaceutical, Jounce Therapeutics, Pfizer, AstraZeneca, Intellisphere Kevin KalinskyStock and Other Ownership Interests: Array BioPharma, Pfizer, GRAILConsulting or Advisory Role: bioTheranostics, Lilly, Pfizer, Novartis, Eisai, AstraZeneca, Genentech/Roche, Immunomedics, Ipsen, Merck, Seattle Genetics, Cyclacel, Oncosec, 4D Pharma, Daiichi Sankyo/Astra Zeneca, Puma BiotechnologySpeakers' Bureau: LillyResearch Funding: Incyte (Inst), Novartis (Inst), Genentech/Roche (Inst), Lilly (Inst), Pfizer (Inst), Calithera Biosciences (Inst), Immunomedics (Inst), Acetylon Pharmaceuticals (Inst), Seattle Genetics (Inst), Amgen (Inst), Zeno Pharmaceuticals (Inst), CytomX Therapeutics (Inst)Travel, Accommodations, Expenses: Lilly, AstraZeneca, PfizerOther Relationship: Immunomedics, Genentech Nicole M. KudererEmployment: Self-employedConsulting or Advisory Role: Janssen, BeyondSpring Pharmaceuticals, Invitae, Bristol Myers Squibb, Samsung Bioepis, G1 Therapeutics, Sandoz-Novartis, BeyondSpring Pharmaceuticals, Teva, MerckResearch Funding: AmgenTravel, Accommodations, Expenses: Janssen, Mylan, Agendia, Bayer, Spectrum Pharmaceuticals Anna LitvakConsulting or Advisory Role: Bristol Myers Squibb, bioTheranostics Erica L. MayerConsulting or Advisory Role: Lilly, Novartis, AstraZeneca, Gilead SciencesResearch Funding: Pfizer (Inst) Lajos PusztaiHonoraria: bioTheranostics, Natera, OncoCyte, AthenexConsulting or Advisory Role: H3 Biomedicine, Merck, Novartis, Seattle Genetics, Syndax, AstraZeneca, Roche/Genentech, Bristol Myers Squibb, Clovis Oncology, Immunomedics, Eisai, Almac Diagnostics, PfizerResearch Funding: Merck (Inst), Genentech (Inst), Seattle Genetics (Inst), AstraZeneca (Inst), Bristol Myers Squibb (Inst), Pfizer (Inst)Travel, Accommodations, Expenses: AstraZenecaUncompensated Relationships: NanoString Technologies, Foundation MedicineOpen Payments Link: https://openpaymentsdata.cms.gov/physician/110878 Antonio C. WolffThis author is an Associate Editor for Journal of Clinical Oncology. Journal policy recused the author from having any role in the peer review of this manuscript.Consulting or Advisory Role: Ionis PharmaceuticalsPatents, Royalties, Other Intellectual Property: Antonio Wolff has been named as inventor on one or more issued patents or pending patent applications relating to methylation in breast cancer, and has assigned his rights to JHU, and participates in a royalty sharing agreement with JHUOpen Payments Link: https://openpaymentsdata.cms.gov/physician/357301/summary Vered StearnsConsulting or Advisory Role: NovartisResearch Funding: AbbVie (Inst), Pfizer (Inst), Novartis (Inst), Puma Biotechnology (Inst), Biocept (Inst)Other Relationship: Immunomedics, AstraZenecaNo other potential conflicts of interest were reported. Fabrice AndreStock and Other Ownership Interests: PegacsyResearch Funding: AstraZeneca (Inst), Novartis (Inst), Pfizer (Inst), Lilly (Inst), Roche (Inst), Daiichi (Inst).Travel, Accommodations, Expenses: Novartis, Roche, GlaxoSmithKline, AstraZeneca Nofisat IsmailaEmployment: GlaxoSmithKline (I)Stock and Other Ownership Interests: GlaxoSmithKline (I) Kimberly H. AllisonConsulting or Advisory Role: MammotomeExpert Testimony: Kaiser Permanente William E. BarlowResearch Funding: Merck (Inst), AstraZeneca (Inst). Deborah E. CollyarHonoraria: PfizerConsulting or Advisory Role: Parexel, MaxisIT, Kinnate BiopharmaTravel, Accommodations, Expenses: Parexel Senthil DamodaranResearch Funding: EMD Serono (Inst), Guardant Health (Inst), Taiho Pharmaceutical (Inst), Novartis (Inst), Sermonix Pharmaceuticals (Inst) N. Lynn HenryResearch Funding: Blue Note Therapeutics (Inst)Open Payments Link: https://openpaymentsdata.cms.gov/physician/27894/summary Komal JhaveriConsulting or Advisory Role: Novartis, Pfizer, AstraZeneca, Jounce Therapeutics, Synthon, Intellisphere, Bristol Myers Squibb, Genentech, AbbVie, Lilly, BluePrint Medicines, Seattle Genetics, Daiichi Sankyo, Biotheranostics, SunPharma Pvt Ltd, Taiho Oncology, SanofiResearch Funding: Novartis (Inst), Genentech (Inst), Debiopharm Group (Inst), ADC Therapeutics (Inst), Pfizer (Inst), Novita Pharmaceuticals (Inst), Clovis Oncology (Inst), Lilly (Inst), Zymeworks (Inst), Immunomedics (Inst), Puma Biotechnology (Inst), VelosBio/Merck (Inst), AstraZeneca (Inst)Travel, Accommodations, Expenses: Taiho Pharmaceutical, Jounce Therapeutics, Pfizer, AstraZeneca, Intellisphere Kevin KalinskyStock and Other Ownership Interests: Array BioPharma, Pfizer, GRAILConsulting or Advisory Role: bioTheranostics, Lilly, Pfizer, Novartis, Eisai, AstraZeneca, Genentech/Roche, Immunomedics, Ipsen, Merck, Seattle Genetics, Cyclacel, Oncosec, 4D Pharma, Daiichi Sankyo/Astra Zeneca, Puma BiotechnologySpeakers' Bureau: LillyResearch Funding: Incyte (Inst), Novartis (Inst), Genentech/Roche (Inst), Lilly (Inst), Pfizer (Inst), Calithera Biosciences (Inst), Immunomedics (Inst), Acetylon Pharmaceuticals (Inst), Seattle Genetics (Inst), Amgen (Inst), Zeno Pharmaceuticals (Inst), CytomX Therapeutics (Inst)Travel, Accommodations, Expenses: Lilly, AstraZeneca, PfizerOther Relationship: Immunomedics, Genentech Nicole M. KudererEmployment: Self-employedConsulting or Advisory Role: Janssen, BeyondSpring Pharmaceuticals, Invitae, Bristol Myers Squibb, Samsung Bioepis, G1 Therapeutics, Sandoz-Novartis, BeyondSpring Pharmaceuticals, Teva, MerckResearch Funding: AmgenTravel, Accommodations, Expenses: Janssen, Mylan, Agendia, Bayer, Spectrum Pharmaceuticals Anna LitvakConsulting or Advisory Role: Bristol Myers Squibb, bioTheranostics Erica L. MayerConsulting or Advisory Role: Lilly, Novartis, AstraZeneca, Gilead SciencesResearch Funding: Pfizer (Inst) Lajos PusztaiHonoraria: bioTheranostics, Natera, OncoCyte, AthenexConsulting or Advisory Role: H3 Biomedicine, Merck, Novartis, Seattle Genetics, Syndax, AstraZeneca, Roche/Genentech, Bristol Myers Squibb, Clovis Oncology, Immunomedics, Eisai, Almac Diagnostics, PfizerResearch Funding: Merck (Inst), Genentech (Inst), Seattle Genetics (Inst), AstraZeneca (Inst), Bristol Myers Squibb (Inst), Pfizer (Inst)Travel, Accommodations, Expenses: AstraZenecaUncompensated Relationships: NanoString Technologies, Foundation MedicineOpen Payments Link: https://openpaymentsdata.cms.gov/physician/110878 Antonio C. WolffThis author is an Associate Editor for Journal of Clinical Oncology. Journal policy recused the author from having any role in the peer review of this manuscript.Consulting or Advisory Role: Ionis PharmaceuticalsPatents, Royalties, Other Intellectual Property: Antonio Wolff has been named as inventor on one or more issued patents or pending patent applications relating to methylation in breast cancer, and has assigned his rights to JHU, and participates in a royalty sharing agreement with JHUOpen Payments Link: https://openpaymentsdata.cms.gov/physician/357301/summary Vered StearnsConsulting or Advisory Role: NovartisResearch Funding: AbbVie (Inst), Pfizer (Inst), Novartis (Inst), Puma Biotechnology (Inst), Biocept (Inst)Other Relationship: Immunomedics, AstraZenecaNo other potential conflicts of interest were reported.

Purpose: To update the American Society of Clinical Oncology endorsement of the Cancer Care Ontario recommendations on the Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer., Methods: Two phase III trials-the Trial Assigning Individualized Options for Treatment (TAILORx) in women with hormone receptor-positive, node-negative tumors and the Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy (MINDACT) trial-provided the evidence for this update., Updated Recommendations: Shared decision making between clinicians and patients is appropriate for adjuvant systemic therapy for breast cancer. For patients older than age 50 years and whose tumors have Onco type DX recurrence scores less than 26, and for patients age 50 years or younger whose tumors have Onco type DX recurrence scores less than 16, there is little to no benefit from chemotherapy. Clinicians may offer endocrine therapy alone for these patients. For patients age 50 years or younger with recurrence scores of 16 to 25, clinicians may offer chemoendocrine therapy. Patients with recurrence scores greater than 30 should be considered candidates for chemoendocrine therapy. Based on informal consensus, the Panel recommends that oncologists may offer chemoendocrine therapy to patients with Onco type DX scores of 26 to 30.The MammaPrint assay could be used to guide decisions on withholding adjuvant systemic chemotherapy in patients with hormone receptor-positive lymph node-negative breast cancer and in select patients with lymph node-positive cancers. In both patients with node-positive and node-negative disease, evidence of clinical utility of the MammaPrint assay was only apparent in those determined to be at high clinical risk; the Panel thus did not recommend use of MammaPrint assay in patients determined to be at low clinical risk. Remaining recommendations from the 2016 ASCO guideline endorsement are unchanged.Additional information is available at www.asco.org/breast-cancer-guidelines.

Purpose: This focused update addresses the use of Onco type DX in guiding decisions on the use of adjuvant systemic therapy., Methods: ASCO uses a signals approach to facilitate guideline updating. For this focused update, the publication of the Trial Assigning Individualized Options for Treatment (TAILORx) evaluating noninferiority of endocrine therapy alone versus chemoendocrine therapy for invasive disease-free survival in women with Onco type DX scores provided a signal. An expert panel reviewed the results of TAILORx along with other published literature on the Onco type DX assay to assess for evidence of clinical utility., Updated Recommendations: For patients with hormone receptor-positive, axillary node-negative breast cancer whose tumors have Onco type DX recurrence scores of less than 26, there is little to no benefit from chemotherapy, especially for patients older than age 50 years. Clinicians may recommend endocrine therapy alone for women older than age 50 years. For patients 50 years of age or younger with recurrence scores of 16 to 25, clinicians may offer chemoendocrine therapy. Patients with recurrence scores greater than 30 should be considered candidates for chemoendocrine therapy. Based on informal consensus, the panel recommends that oncologists may offer chemoendocrine therapy to these patients with recurrence scores of 26 to 30. Additional information can be found at www.asco.org/breast-cancer-guidelines.

Purpose This focused update addresses the use of MammaPrint (Agendia, Irvine, CA) to guide decisions on the use of adjuvant systemic therapy. Methods ASCO uses a signals approach to facilitate guideline updates. For this focused update, the publication of the phase III randomized MINDACT (Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy) study to evaluate the MammaPrint assay in 6,693 women with early-stage breast cancer provided a signal. An expert panel reviewed the results of the MINDACT study along with other published literature on the MammaPrint assay to assess for evidence of clinical utility. Recommendations If a patient has hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-negative breast cancer, the MammaPrint assay may be used in those with high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy due to its ability to identify a good-prognosis population with potentially limited chemotherapy benefit. Women in the low clinical risk category did not benefit from chemotherapy regardless of genomic MammaPrint risk group. Therefore, the MammaPrint assay does not have clinical utility in such patients. If a patient has hormone receptor-positive, HER2-negative, node-positive breast cancer, the MammaPrint assay may be used in patients with one to three positive nodes and a high clinical risk to inform decisions on withholding adjuvant systemic chemotherapy. However, such patients should be informed that a benefit from chemotherapy cannot be excluded, particularly in patients with greater than one involved lymph node. The clinician should not use the MammaPrint assay to guide decisions on adjuvant systemic therapy in patients with hormone receptor-positive, HER2-negative, node-positive breast cancer at low clinical risk, nor any patient with HER2-positive or triple-negative breast cancer, because of the lack of definitive data in these populations. Additional information can be found at www.asco.org/breast-cancer-guidelines and www.asco.org/guidelineswiki .

Purpose: To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer., Methods: A literature search and prospectively defined study selection sought systematic reviews, meta-analyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations., Results: The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospective-retrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens., Recommendations: In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences., (© 2016 by American Society of Clinical Oncology.)