CARDOSO

“In terms of safety, the elinzanetant was very well tolerated, with no major [adverse] effects.”

Fatima Cardoso, MD, MSc, FESMO, director of the Breast Unit of the Champalimaud Clinical Center in Lisbon, discussed safety and quality-of-life (QOL) outcomes with elinzanetant given for the treatment of hot flashes in women undergoing adjuvant endocrine therapy for hormone receptor–positive breast cancer.

Findings from the phase 3 OASIS-4 trial (NCT05587296) demonstrated that the neurokinin-1/3 receptor antagonist was well tolerated and provided meaningful improvements in vasomotor symptoms and menopause-related quality of life.

The safety profile of elinzanetant was favorable, with no major adverse effects reported. The most frequent toxicities were mild to moderate in severity, including somnolence, fatigue, and diarrhea. Importantly, more than 90% of patients chose to continue therapy in the optional 2-year extension study, underscoring the agent’s tolerability and patient acceptance.

Beyond safety, secondary end points evaluated the impact of elinzanetant on vasomotor symptoms, sleep disturbances, and menopause-related QOL. Treatment was associated with clinically meaningful improvements across all QOL domains, suggesting that elinzanetant may represent an effective nonhormonal strategy for managing treatment-related toxicities in this population.

According to Cardoso, these results highlight the potential of elinzanetant to improve adherence to adjuvant endocrine therapy by reducing symptom burden without introducing significant toxicity. Vasomotor symptoms remain a leading cause of treatment discontinuation, which can negatively affect long-term outcomes in patients with hormone receptor–positive breast cancer. By addressing this challenge, elinzanetant could serve as an important supportive care intervention to optimize the patient experience and sustain therapy adherence.

Future efforts will focus on further characterizing the long-term safety and efficacy of elinzanetant in the extended treatment setting. Cardoso emphasized that the consistency of findings across safety and QOL measures supports elinzanetant as a promising option for women receiving adjuvant endocrine therapy, and she expressed optimism that regulatory approval could soon provide patients with timely access to this therapy.

Videos

Fatima Cardoso, MD, MSc, FESMO, discusses quality-of-life outcomes with elinzanetant for the management of hot flashes in hormone receptor–positive breast cancer.

Dr Cardoso on Outcomes With Elinzanetant for Hot Flashes in HR+ Breast Cancer

"In the OASIS 4 trial, [regarding] the primary end point, which was change in the frequency of moderate-to-severe vasomotor symptoms from baseline to weeks 4 and 12, we saw a statistically significant and clinically meaningful reduction in symptom frequency with elinzanetant compared with placebo."

Fatima Cardoso, MD, MSc, FESMO, director of the Breast Unit at the Champalimaud Clinical Center in Lisbon, Portugal, discussed findings from the phase 3 OASIS 4 trial (NCT05587296), which evaluated the effect of elinzanetant on vasomotor symptoms and overall quality of life (QOL) in women undergoing adjuvant endocrine therapy for hormone receptor–positive breast cancer.

The trial assessed the efficacy of elinzanetant—a selective neurokinin-1,3 receptor antagonist—in reducing moderate-to-severe vasomotor symptoms associated with endocrine therapy. Findings presented at the 2025 ASCO Annual Meeting showed that patients treated with elinzanetant(n = 316) experienced a statistically significant reduction in vasomotor symptom frequency and severity from baseline to week 4 and week 12 compared with those receiving placebo (n = 158). Among patients initially randomly assigned to receive placebo, symptom burden decreased rapidly following crossover to the elinzanetant arm at week 12, confirming a consistent and durable treatment effect.

Elinzanetant demonstrated a rapid onset of action, with measurable symptom improvement observed by week 1. This benefit was maintained through the 12-week core treatment period and extended across the 40-week continuation phase, totaling 52 weeks of therapy. Additionally, an optional 2-year extension period is ongoing to assess the long-term safety and efficacy of the intervention.

Vasomotor symptoms remain a leading cause of nonadherence to endocrine therapy, and agents like elinzanetant may offer a nonhormonal strategy to enhance tolerability. Improvements in sleep quality, a secondary concern often linked to nocturnal hot flashes, were also observed. These findings underscore the clinical utility of elinzanetant in addressing key QOL issues without compromising the oncologic benefit of endocrine therapy.

Cardoso noted that the early and sustained symptom control with elinzanetant supports its role as a viable supportive care option for women with breast cancer receiving endocrine therapy. The agent’s nonhormonal mechanism is particularly relevant for this population, where hormone modulation is a cornerstone of systemic treatment.

Fatima Cardoso, MD, MSc, FESMO, discusses the use of elinzanetant for vasomotor symptoms in women receiving endocrine therapy for HR+ breast cancer.

Dr Cardoso on the Effect of Elinzanetant on Vasomotor Symptoms in HR+ Breast Cancer

Fatima Cardoso, MD, coordinator, European School of Oncology Breast Cancer Program, Secretary General, European Organization for Research and Treatment of Cancer, director, Breast Unit, Champalimaud Clinical Cancer Center, discusses the Global mBC Vision 2025 Call-to-Action.

The Breast Cancer Decade Report identified important gaps in the scientific and cancer care areas for patients with metastatic breast cancer. With an international task force, those gaps were addressed, states Cardoso.

The call-to-action is a list of objectives that can be addressed in a 10-year-period, explains Cardoso.

Dr. Cardoso on the Global mBC Vision 2025 Call-to-Action

Fatima Cardoso, MD, coordinator, European School of Oncology Breast Cancer Program, Secretary General, European Organization for Research and Treatment of Cancer, director, Breast Unit, Campalimaud Clinical Cancer Center, discusses the rationale behind the 

 was developed to improve and extend the lives of patients with advanced and/or metastic breast cancer by the year 2025. It outlines 10 key gaps in patient care, societal support, and scientific investment for this disease.

According to Cardoso, one of the main reasons behind this Call-to-Action, which was detailed in the 

Global Status of Advanced/Metastatic Breast Cancer 2005-2015 Decade Report

, was low epidemiology numbers regarding metastatic disease across the globe. To be able to determine resources to help these patients, Cardoso adds, the population must be known—and initiatives are now being started to find this.

Cardoso says that patients need to be treated in a multidisciplinary approach that incorporates palliative care, psychosocial support, nutrition, and sometimes radiation or surgery.

Fatima Cardoso, MD, coordinator, European School of Oncology Breast Cancer Program, Secretary General, European Organization for Research and Treatment of Cancer, director, Breast Unit, Campalimaud Clinical Cancer Center, discusses the rationale behind the Global mBC Vision 2025 Call-to-Action.

Fatima Cardoso, MD

Articles

Dr Cardoso on Outcomes With Elinzanetant for Hot Flashes in HR+ Breast Cancer

Dr Cardoso on the Effect of Elinzanetant on Vasomotor Symptoms in HR+ Breast Cancer

Dr. Cardoso on the Global mBC Vision 2025 Call-to-Action

Dr. Cardoso on the Rationale Behind the Global mBC Vision 2025 Call-to-Action