Beating Back Breast Cancer: Study Shows Additional Therapy Effective in Node-Negative Cases

The phase 3 NATALEE trial (NCT03701334) investigated the effectiveness and safety of adding ribociclib (Kisqali) to standard hormone therapy for patients with hormone receptor-positive/HER2-negative (HR+/HER2–) early breast cancer at high risk of recurrence. An analysis presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting included patients with no lymph node involvement (N0 disease).

Patients were randomized to receive either ribociclib with a nonsteroidal aromatase inhibitor (NSAI) or NSAI alone. The N0 subgroup included patients with specific tumor sizes and features indicating high risk.

Adding ribociclib to NSAI improved measures of invasive disease-free survival, distant disease-free survival, and distant recurrence-free survival in patients with high-risk N0 disease. The safety profile of ribociclib in the N0 subgroup was similar to the overall study population.

Overall, the study suggests that ribociclib combined with NSAI may be beneficial for patients with HR+/HER2 early breast cancer at high risk of recurrence, even for those with no lymph node involvement.

Here, Denise Yardley, MD, director of breast cancer research at Sarah Cannon Research Institute in Nashville, Tennessee, discusses the implications of these findings.

Transcription:

0:05 | I think the the key takeaway would be we've seen the benefit in the final interim analysis of the addition of ribociclib to NSAI in stage II and III breast cancer patients with ER-positive, HER2-negative disease. I think now we have more data to support. The majority of the patients on the trial were lymph node-positive and now looking at that same data set in the lymph node-negative patients that were enrolled on the trial with high-risk feature, so the T1 and 0s were excluded, grade 1 patients were excluded, and showing that node-negative, early-stage breast cancer also has risk of recurrence with current standard of care and benefited from the addition of ribociclib to their standard NSAI therapy.

0:55 | So I think the the next steps are, you know, we're continuing to try to risk stratify patients and identify patients who are going to benefit from additional therapies and try to identify those who can be spared chemotherapy and then an additional combination endocrine therapy. I think, you know, the takeaway will be now we we've seen the data for lymph node-positive and we've seen that benefit from another trial and the NATALEE trial and now being able to extend that benefit to a high-risk, lymph node-negative population as part of their adjuvant endocrine treatment strategy. So hoping as this moves forward and the FDA looks at ribociclib in early-stage breast cancer patients, that these high-risk, node-negative patients also stand to benefit from that combination therapy.

Transcription created with AI and edited for clarity.