Treatment

Document Overview

Design and created by Guideline Central in participation with the American Society of Clinical Oncology.

Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

American Society of Clinical Oncology

Publication Date: May 20, 2024

Page Last Updated: May 5, 2026

The Panel recommends, based on the phase III NATALEE trial, that adjuvant ribociclib (400 mg once daily, 3 weeks on followed by 1 week off) for 3 years plus ET may be offered to patients with anatomic stage II or III breast cancer who would have met criteria for study entry and have a high risk of recurrence. ( H, C )

Qualifying statements for Recommendations 1 and 2 on the use of adjuvant abemaciclib and ribociclib:
The Panel believes that adjuvant CDK4/6 inhibitor therapy may not provide meaningful clinical benefit to all patients who would have been eligible for the available trials, especially the lower-risk patients who were included in the NATALEE trial. For example, for most patients with node-negative disease, the risks of ribociclib may outweigh the benefits, with the exception of some patients with the highest risk, node-negative disease. However, the Panel acknowledges that there are insufficient data to specify which subgroups of patients do or do not warrant therapy. The Panel thus recommends considering the benefits, risks, costs, and preferences for each individual patient when deciding whether to recommend therapy.
Among patients meeting criteria for both monarchE and NATALEE, the Panel also notes that, of the two CDK4/6 inhibitors, abemaciclib has longer follow-up, a deepening benefit over time, a shorter duration of therapy, and FDA approval in the adjuvant setting. In this case, the Panel favors using abemaciclib, reserving use of ribociclib in patients who have a contraindication to (e.g., pre-existing high-grade diarrhea) or intolerance of abemaciclib. The Panel characterized the strength of the ribociclib recommendation as conditional, pending future efficacy data and regulatory updates. Although a formal cost-effectiveness analysis was out of scope for this update, it could be informative for some decision-makers considering the costs of both medications. Results from longer-term follow-up will further inform adjuvant therapy decision-making

Grading Table

Recommendation Grading

Type		Benefit/harm		Evidence Quality		Strength of Recommendation
EB	Evidence-based	B	Benefits outweigh harms	H	High	Strong
CB/ FC	Consensus-based/ Formal Consensus	H	Harms outweigh benefits	M	Moderate	Moderate
IC	Informal consensus	B / H	Relative balance of benefits and harms	I	Intermediate	Weak
		U	Benefits/harms ratio uncertain	L	Low
				VL	Very Low
				Ins	Insufficient

Recommendation Rating Definitions

Quality of Evidence

Term	Definitions
H = High	We are very confident that the true effect lies close to that of the estimate of the effect
M = Moderate	We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
L = Low	Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
VL = Very low	We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

Strength of Recommendation

Term	Definitions
S = Strong	In recommendations for an intervention, the desirable effects of an intervention outweigh its undesirable effects. In recommendations against an intervention, the undesirable effects of an intervention outweigh its desirable effects. All or almost all informed people would make the recommended choice for or against an intervention.
C = Conditional/ W = Weak	In recommendations for an intervention, the desirable effects probably outweigh the undesirable effects, but appreciable uncertainty exists. In recommendations against an intervention, the undesirable effects probably outweigh the desirable effects, but appreciable uncertainty exists. Most informed people would choose the recommended course of action, but a substantial number would not.

Brozek JL, Akl EA, Compalati E, et al: Grading quality of evidence and strength of recommendations in clinical practice guidelines part 3 of 3. The GRADE approach to developing recommendations. Allergy 66:588-95, 2011

Document Overview

Document Title: Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

Authoring Society: American Society of Clinical Oncology

Document Publication Date: May 20, 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.24.00886

Source Citation: Freedman RA, Caswell-Jin J, Hassett M, et al. Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer – CDK4/6 Inhibitors: ASCO Rapid Guideline Update. J Clin Oncol. 2024 May 20. doi: 10.1200/JCO.24.00886

Giordano SH, Freedman RA, and Somerfield MR. Abemaciclib with Endocrine Therapy in the Treatment of High-Risk Early Breast Cancer: ASCO Optimal Adjuvant Chemotherapy and Targeted Therapy Guideline Rapid Recommendation Update. J Clin Oncol. 2022 Jan 20;40(3):307-309

Denduluri N, Somerfield MR, Chavez-MacGregor M, et al. Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2021 Feb 20;39(6):685-693.

Denduluri N, Chavez-MacGregor M, Telli ML, et al. Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Clinical Practice Guideline Focused Update. J Clin Oncol. 2018;36(23):2433-2443.

Denduluri N, Somerfield MR, Eisen A, et al. Selection of Optimal Adjuvant Chemotherapy Regimens for Human Epidermal Growth Factor Receptor 2 (HER2)-Negative and Adjuvant Targeted Therapy for HER2-Positive Breast Cancers: An American Society of Clinical Oncology Guideline Adaptation of the Cancer Care Ontario Clinical Practice Guideline. J Clin Oncol. 2016 Jul 10;34(20):2416-2427.

Eisen A, Fletcher GG, Gandhi S, et al. Optimal systemic therapy for early breast cancer in women: A clinical practice guideline. Curr Oncol. 22:S67-S81, 2015 (suppl 1).

Supplemental Implementation Resources

Document Scope, Criteria, and Use Cases

Document Objectives: The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options.

Scope: Management, Treatment

Diseases/Conditions (MeSH)

D000072656 - Breast Cancer Lymphedema

Keywords: Adjuvant chemotherapy, Targeted Therapy, breast cancer, neoadjuvant chemotherapy

Target Patient Population: Patients with early breast cancer

Inclusion Criteria: Female, Adult, Older Adult

Health Care Settings: Ambulatory, Emergency Care, Hospital, Long Term Care

Intended Users: Nurse, Nurse Practitioner, Physician, Physician Assistant, Social Worker

Recommendation Development Processes & Methodology

Supplemental Methodology Resources: Data Supplement Evidence Tables

Number of Source Documents: 77

Literature Search Start Date: Sunday, December 31, 2017

Literature Search End Date: Tuesday, February 18, 2020

Includes peer/external review process?: Yes

Includes public comment process?: Yes

Methodologist involvement?: Yes

Patient involvement?: No

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?: No

Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

Treatment

New Recommendations from 2024 Guideline Rapid Recommendation Update

Use of an Anthracycline-Taxane Regimen

Adding Gemcitabine or Capecitabine to an Anthracycline-Taxane Regimen

Optimal-Dose Anthracycline Regimen for Patients for Whom a Taxane Is Contraindicated

Capecitabine in Patients Age ≥65 Years

Cyclophosphamide-Methotrexate-Fluorouracil As an Alternative To Doxorubicin-Cyclophosphamide

Acceptable Adjuvant Chemotherapy Regimens for Patients with Higher-Risk Early Breast Cancer

Adjuvant Regimen When an Anthracycline Is Not Preferred

Patient Selection and Adjuvant Trastuzumab Therapy

Trastuzumab Plus Chemotherapy in Patients with Higher-Risk HER2-Positive Disease

Trastuzumab Plus Chemotherapy in Patients with HER2-Positive T1a-B N0 Disease

Selection of Chemotherapy Regimens in Patients Receiving Trastuzumab

Use of Trastuzumab and an Anthracycline-Containing Regimen

Concurrent Administration of Adjuvant Trastuzumab and Non-Anthracycline Chemotherapy Regimens

Trastuzumab-Based Chemotherapy or Trastuzumab Regimens For Patients at Higher Risk of Cardiotoxicity

Addition of Trastuzumab to Chemotherapy Regimens Not Evaluated in a Phase III Trial

Duration of Trastuzumab Therapy and Cardiac Function

Adjuvant Capecitabine

Adjuvant Pertuzumab

Adjuvant Neratinib

Grading Table

Recommendation Grading

Recommendation Rating Definitions

Quality of Evidence

Strength of Recommendation

Document Overview

Supplemental Implementation Resources

Document Scope, Criteria, and Use Cases

Recommendation Development Processes & Methodology