23 Clinical Outcomes in Patients With HR+/HER2− Early Breast Cancer By Prior Systemic Treatment: A Subgroup Analysis of the NATALEE Trial

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement42nd Annual Miami Breast Cancer Conference® - Abstracts
Volume 39
Issue 4
Pages: 14-15

23 Clinical Outcomes in Patients With HR+/HER2− Early Breast Cancer By Prior Systemic Treatment: A Subgroup Analysis of the NATALEE Trial

23 Clinical Outcomes in Patients With HR+/HER2− Early Breast Cancer By Prior Systemic Treatment: A Subgroup Analysis of the NATALEE Trial

Background

NATALEE met its primary end point with a significant invasive disease-free survival (iDFS) benefit with ribociclib plus nonsteroidal aromatase inhibitor (NSAI) vs NSAI in patients with hormone receptor–positive (HR+)/HER2-negative (HER2–) early breast cancer (EBC) that was sustained with additional follow-up (median follow-up, 33.3 months; HR, 0.749). We analyzed iDFS by prior systemic treatment (chemotherapy [CT], endocrine therapy [ET]) in NATALEE using data from the final prespecified iDFS analysis (data cutoff: July 21, 2023).

Materials and Methods

Patients were randomized 1:1 to ribociclib 400 mg/d (3 weeks on/1 week off for 36 months) plus NSAI (≥ 60 months) or NSAI. Men and premenopausal women received goserelin. Eligible patients had anatomic stage IIA (high-risk N0 or N1), IIB, or III EBC, regardless of prior (neo)adjuvant CT. Patients starting ET ≤12 months before randomization were included.

Results

Of 5101 patients, 88% received prior CT, 43% had prior neoadjuvant CT, and 48% had prior adjuvant CT. Of 1432 patients with N0 disease at diagnosis, most had prior CT (78%). Most patients (73%) with prior neoadjuvant CT had stage III disease, while 19% with no prior CT had stage III disease. Overall, 69% of patients received prior ET (median duration of last prior ET was 3.2 months). An iDFS benefit with ribociclib plus NSAI was observed regardless of prior CT or duration of ET (Table).

Conclusion

This subgroup analysis demonstrated an iDFS benefit with ribociclib plus NSAI vs NSAI alone in patients with HR+/HER2− EBC, regardless of duration of prior ET as well as prior (neo)adjuvant CT vs no CT, underlying the potential role of CDK4/6 inhibitors in therapeutic de-escalation of CT in EBC. A majority of patients with N0 disease at diagnosis had received prior (neo)adjuvant CT, highlighting that these patients had a risk of recurrence that was considered high enough to warrant CT.

Articles in this issue

2 Preventive Care and Screening Adherence Among Women Surviving Breast Cancer
2 Preventive Care and Screening Adherence Among Women Surviving Breast Cancer
3 Intraoperative Radiotherapy: Alive and Well in the Bronx
3 Intraoperative Radiotherapy: Alive and Well in the Bronx
4 Evaluating AI-Driven Responses in Breast Reconstruction: A Comparative Study of Response Formats
4 Evaluating AI-Driven Responses in Breast Reconstruction: A Comparative Study of Response Formats
5 Correlation Between Visual Impairment and Breast Cancer: A Cross-Sectional Study Based on the National Health Interview Surveys
5 Correlation Between Visual Impairment and Breast Cancer: A Cross-Sectional Study Based on the National Health Interview Surveys
6 Peer Support Programming Among Women At-Risk for Surviving Breast Cancer: Facilitators and Barriers to Community-Based Patient Navigation and the Role of Quality of Life
6 Peer Support Programming Among Women At-Risk for Surviving Breast Cancer: Facilitators and Barriers to Community-Based Patient Navigation and the Role of Quality of Life
7 Metaplastic Breast Cancer: A Retrospective Chart Review of Clinical Features
7 Metaplastic Breast Cancer: A Retrospective Chart Review of Clinical Features
8 A Case Series Exploring Characteristics and Outcomes of Metachronous Primary Breast and Lung Cancer in a Diverse Cohort
8 A Case Series Exploring Characteristics and Outcomes of Metachronous Primary Breast and Lung Cancer in a Diverse Cohort
9 Body Mass Index, Cancer Risk Behaviors, and Readiness for Dietary Change Among Women Surviving With Breast Cancer
9 Body Mass Index, Cancer Risk Behaviors, and Readiness for Dietary Change Among Women Surviving With Breast Cancer
10 AI as a Bridge: Can ChatGPT Help Patients Understand Their Breast Radiology Reports?
10 AI as a Bridge: Can ChatGPT Help Patients Understand Their Breast Radiology Reports?
12 Gut Microbiome Composition and Pathological Complete Response After Chemotherapy in Breast Cancer: Insights From a Pilot Study
12 Gut Microbiome Composition and Pathological Complete Response After Chemotherapy in Breast Cancer: Insights From a Pilot Study
13 Preliminary Analysis of Change During Treatment of Financial Toxicity and Quality of Life in Breast Cancer Patients
13 Preliminary Analysis of Change During Treatment of Financial Toxicity and Quality of Life in Breast Cancer Patients
15 Utilizing Circulating Tumor Cells to Guide HER2-Directed Therapy in IHC/FISH-Negative HER2+ Metastatic Breast Cancer
15 Utilizing Circulating Tumor Cells to Guide HER2-Directed Therapy in IHC/FISH-Negative HER2+ Metastatic Breast Cancer
16 A Miami Hospital’s Infrastructure to Help Decrease Late-Stage Breast Cancer Diagnosis and Improve Health Equity
16 A Miami Hospital’s Infrastructure to Help Decrease Late-Stage Breast Cancer Diagnosis and Improve Health Equity
17 Salmonella and the Breast: A Literature Review of Salmonella-Induced Breast Abscesses
17 Salmonella and the Breast: A Literature Review of Salmonella-Induced Breast Abscesses
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
Recent Videos
Leading experts in the breast cancer field highlight the use of CDK4/6 inhibitors, antibody-drug conjugates, and other treatment modalities.
Patients with node-negative disease who are older and have comorbidities may not be suitable to receive CDK4/6 inhibitors.
An observed carryover effect with CDK4/6 inhibitors may reduce the risk of recurrence years after a patient stops treatment.
Breast oncologist Jade E. Jones, MD, says she tries to send patients with BRCA-mutant HR-positive TNBC to clinical trials that use PARP inhibitors.
Related Content