Endocrine Treatment and Targeted Therapy for HR-Positive, HER2-Negative Metastatic Breast Cancer

Document Overview

Document Title

Endocrine Treatment and Targeted Therapy for HR-Positive, HER2-Negative Metastatic Breast Cancer

Authoring Society

American Society of Clinical Oncology

Document Publication Date

Mar 13, 2024

Page Last Reviewed/Updated

May 5, 2026

Document Type

Guideline

Country of Publication

United States

Full Text Freely Available

Yes

Full Text Guideline

ascopubs.org/doi/full/10.1200/JCO.24.00248

Source Citation

Burstein HJ, et al., Endocrine and Targeted Therapy for Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Metastatic Breast Cancer—Capivasertib-Fulvestrant: ASCO Rapid Recommendation Update. J Clin Oncol. 2024 March 13 doi:10.1200/JCO.24.00248

Burstein HJ, et al. Testing for ESR1 Mutations to Guide Therapy for HR-Positive, HER2-Negative Metastatic Breast Cancer: ASCO Guideline Rapid Recommendation Update. J Clin Oncol. 2023 May 17 doi: 10.1200/JCO.23.00638.

Burstein HJ et al. Endocrine Treatment and Targeted Therapy for HR-Positive, HER2-Negative Metastatic Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2021 July 29 doi: 10.1200/JCO.21.01392.

Supplemental Implementation Resources

• Algorithm
• Visual Abstract
• Patient Information
• Podcast
• Slide Set
• Slide Set

Document Scope, Criteria, and Use Cases

Document Objectives

Patients with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer (MBC) have emerging therapeutic options including novel endocrine and targeted agents, with treatment informed by genomic biomarker testing. The CAPItello-291 phase III, double-blind, randomized controlled trial (RCT) evaluating fulvestrant with the AKT pathway inhibitor capivasertib and subsequent US Food and Drug Administration approval of capivasertib and a companion diagnostic device on November 16, 2023, constituted strong signals for updating ASCO MBC guidelines.

Scope

Management, Treatment

Keywords

HER2, HER2-Negative, Metastatic Breast Cancer, breast cancer

Target Patient Population

Women and men with HR-positive, HER2-negative MBC

Target Provider Population

Oncology specialists, other health care providers (including primary care physicians, specialists, nurses, social workers, and any other relevant member of a comprehensive multidisciplinary cancer care team

Inclusion Criteria

Male, Female, Adult, Older Adult

Health Care Settings

Ambulatory, Hospital, Outpatient

Intended Users

Nurse, Nurse Practitioner, Physician, Physician Assistant

Recommendation Development Processes & Methodology

Supplemental Methodology Resources

Data Supplement Evidence Tables

Number of Source Documents

71

Literature Search Start Date

Thursday, December 31, 2015

Literature Search End Date

Monday, November 30, 2020

Includes peer/external review process?

Yes

Includes public comment process?

Yes

Methodologist involvement?

Yes

Patient involvement?

Yes

Includes multi-disciplinary group?

Yes

Includes systematic review?

Yes

Grades quality of strength of evidence?

Yes

Grades quality of strength of recommendation?

Yes

Discloses funding source?

Yes

Discloses conflicts of interest?

Yes

Includes benefits/harms analysis with recommendations?

Yes