21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer

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Miami Breast Cancer Conference® Abstracts Supplement42nd Annual Miami Breast Cancer Conference® - Abstracts
Volume 39
Issue 4
Pages: 12-13

21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer

21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer

Background

In NATALEE, ribociclib plus a nonsteroidal aromatase inhibitor (NSAI) demonstrated invasive disease-free survival (iDFS) and distant disease-free survival (DDFS) benefits in patients with stage II/III hormone receptor–positive (HR+)/HER2-negative (HER2–) early breast cancer (EBC). In an analysis with all patients off ribociclib, ribociclib plus an NSAI reduced the risk of distant disease recurrence vs NSAI. We present DDFS data from the 4-year landmark analysis of NATALEE across clinically relevant subgroups.

Materials and Methods

In NATALEE, patients were randomized 1:1 to receive ribociclib (400 mg/day, 3 weeks on/1 week off for 3 years) plus an NSAI (anastrozole 1 mg/day or letrozole 2.5 mg/day for 5 years) or NSAI, with men and premenopausal women receiving goserelin. NATALEE included patients with anatomic stage IIA (node-negative [N0] with additional risk factors or N1 [1-3 axillary lymph nodes]), IIB, or III disease per AJCC (8th edition). DDFS was a secondary end point, defined as the time from randomization to the first event of distant recurrence, second primary nonbreast invasive cancer (except for basal/squamous cell skin carcinomas), or death from any cause. DDFS was assessed across pt subgroups, including anatomic stage and nodal status, using Kaplan–Meier analysis and Cox proportional hazards model.

Results

At the data cutoff of April 29, 2024 (median duration of follow-up for DDFS, 44.2 months, all patients off ribociclib), ribociclib plus NSAI demonstrated a DDFS benefit (HR, 0.715; 95% CI, 0.604-0.847; nominal P value <.0001) and a distant recurrence-free survival benefit (HR, 0.705; 95% CI, 0.589-0.844; nominal P value <.0001) in the intent-to-treat population. The DDFS benefit was consistent regardless of the anatomic stage. The absolute DDFS benefit with ribociclib plus NSAI vs NSAI alone increased from 3 years to 4 years for all stage subgroups. Similarly, a consistent improvement in DDFS was observed regardless of nodal status, and the absolute DDFS benefit increased from 3 years to 4 years across nodal subgroups. The DDFS benefit with ribociclib plus NSAI vs NSAI, with an increasing benefit up to 4 years, was consistent across other clinically relevant subgroups, including menopausal and Ki-67 status.

Conclusion

With all patients off ribociclib, ribociclib plus NSAI consistently reduced the risk of distant recurrence across clinically relevant subgroups, including N0 disease. The DDFS benefit was sustained after the 3-year ribociclib treatment duration, with increasing absolute benefit up to 4 years. These findings further support adding ribociclib to adjuvant NSAI in a broad population of patients with HR+/HER2− EBC.

Articles in this issue

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
20 Impact of Ribociclib Dose Reduction on Efficacy in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast
20 Impact of Ribociclib Dose Reduction on Efficacy in Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Early Breast
21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer
21 Distant Disease-Free Survival Across Key Subgroups From the Phase 3 NATALEE Trial of Ribociclib Plus a Nonsteroidal Aromatase Inhibitor in Patients With HR+/HER2− Early Breast Cancer
22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE
22 Efficacy and Safety of Ribociclib + Nonsteroidal Aromatase Inhibitor in Younger Patients With HR+/HER2− Early Breast Cancer in NATALEE
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
TPS 24 Phase Ib Dose-Finding Study of [177Lu]Lu-NeoB + Ribociclib + Fulvestrant in Patients With ER+/HER2− Advanced Breast Cancer With GRPR Expression With Early Relapse FromAdjuvant Endocrine Therapy or Progression on ET + CDK4/6i for ABC
TPS 24 Phase Ib Dose-Finding Study of [177Lu]Lu-NeoB + Ribociclib + Fulvestrant in Patients With ER+/HER2− Advanced Breast Cancer With GRPR Expression With Early Relapse FromAdjuvant Endocrine Therapy or Progression on ET + CDK4/6i for ABC
TPS 25 Phase 1/2 Study of the Novel Radioligand Therapy [177Lu]Lu-NeoB Plus Capecitabine in Patients With ER+/HER2− Advanced Breast Cancer (ABC) With GRPR Expression After Progression on Prior Endocrine Therapy Plus a CDK4/6 Inhibitor for ABC
TPS 25 Phase 1/2 Study of the Novel Radioligand Therapy [177Lu]Lu-NeoB Plus Capecitabine in Patients With ER+/HER2− Advanced Breast Cancer (ABC) With GRPR Expression After Progression on Prior Endocrine Therapy Plus a CDK4/6 Inhibitor for ABC
26 Risk of Recurrence in Real-World NATALEE- and monarchE-Eligible Populations of Patients With HR+/HER2− Early Breast Cancer in an Electronic Health Record-Derived Database
26 Risk of Recurrence in Real-World NATALEE- and monarchE-Eligible Populations of Patients With HR+/HER2− Early Breast Cancer in an Electronic Health Record-Derived Database
27 Elacestrant vs Standard of Care in ER+, HER2- Advanced or Metastatic Breast Cancer With ESR1-Mutated Tumors: ESR1 Allelic Frequencies and Clinical Activity From the Phase 3 EMERALD Trial
27 Elacestrant vs Standard of Care in ER+, HER2- Advanced or Metastatic Breast Cancer With ESR1-Mutated Tumors: ESR1 Allelic Frequencies and Clinical Activity From the Phase 3 EMERALD Trial
TPS 28 ELEGANT: Elacestrant VS Standard Endocrine Therapy in Women and Men With Node-Positive, Estrogen Receptor-Positive, HER2-Negative, Early Breast Cancer With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-Label Phase 3 Study
TPS 28 ELEGANT: Elacestrant VS Standard Endocrine Therapy in Women and Men With Node-Positive, Estrogen Receptor-Positive, HER2-Negative, Early Breast Cancer With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-Label Phase 3 Study

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