New RT Paper Alert: Novel NOVEMBER Trial Puts 9-Day Breast Cancer Radiation Schedule to the Test

A new Phase 2 NOVEMBER trial, successfully tested a remarkably short, 9-day course of whole breast radiation therapy for early-stage breast cancer patients. This novel regimen, which simultaneously delivers a boost to the lumpectomy cavity, demonstrated highly effective local cancer control and low toxicity, paving the way for a more convenient treatment option.

Radiation therapy is a crucial component of breast cancer treatment, significantly reducing the risk of recurrence and enabling women to safely choose breast-conserving surgery. While standard radiation schedules once spanned 6 to 8 weeks, accelerated hypofractionation has safely shortened treatment to a few weeks. The NOVEMBER trial sought to further condense this schedule, aiming to provide a comprehensive, two-week treatment that minimizes time away from home for patients, particularly those in rural areas.

Trial Design and Key Findings of NOVEMBER Trial

The prospective, single-arm trial enrolled 102 women with early-stage breast cancer. The patients received 34.2 Gy to the whole breast and 39.6 Gy to the lumpectomy cavity, all delivered in just nine consecutive daily treatments.

Local Control: With a mean follow-up of 51 months, the trial’s most significant finding was its zero local breast cancer recurrences. This outcome compares favorably to local recurrence rates seen in longer, established trials, suggesting the regimen is highly effective at controlling the disease.

Patient Satisfaction and Toxicity: This ultrashort schedule was well-tolerated. No patient reported any late Grade 3 or higher toxicities. Only four patients experienced late Grade 2 events, such as breast or chest wall pain. Furthermore, patient-reported outcomes from the Breast-Q survey revealed that 85% of women were satisfied with their breasts 24 months after treatment.

Cosmetic Outcomes: The NOVEMVER trial’s primary endpoint—a good-to-excellent cosmetic score in over 70% of patients at 24 months—was not met, with an actual result of 68%. However, the researchers noted that their goal may have been overly ambitious compared to other trials that include a boost. More positively, a change-from-baseline analysis showed that 80% of patients experienced either an improvement or no noticeable cosmetic change.

(a) NOVEMBER Trial Breast-Q results. (b) Breast-Q comparisons to published outcomes. Figures have been shown with 95% confidence intervals. Howes et al43 lumpectomy patients, Oemrawsingh et al42 breast surgery only patients, Mundy et al44 nonbreast cancer “normal,” population.

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Conclusion and Future Outlook NOVEMBER Trial

The NOVEMBER trial successfully proves that this 9-day radiation schedule with a simultaneous boost is a safe and effective approach. Despite narrowly missing its specific cosmetic endpoint, the trial delivered excellent clinical outcomes and high patient satisfaction.

The researchers plan to advance this concept in a follow-on Phase 2 randomized trial. This new trial will directly compare the 9-day NOVEMBER schedule against a 5-day “Fast Forward” schedule, with both including a simultaneous boost. This will be the first randomized comparison of its kind and will help determine if the 9-day course offers a superior patient experience and cosmetic results compared to an even shorter, more intense regimen.

Read Full Artilce On: International Journal of Radiation Oncology, Biology, Physics

Written By Aren Karapetyan, MD