Fezolinetant Trial for Hot Flashes in Patients With HR+ Breast Cancer Starts Enrollment

Microscopic image of breast cancer cells - Generated with Google Gemini AI

The first patient has been dosed in the phase 3 HIGHLIGHT 1 (NCT06440967) trial of fezolinetant (Veozah) for the potential treatment of patients with moderate to severe vasomotor symptoms (VMS) with breast cancer receiving adjuvant endocrine therapy.¹

"VMS can adversely affect quality-of-life, as well as compliance with treatment, for patients with breast cancer taking adjuvant endocrine therapy. We are excited to get the HIGHLIGHT 1 study underway, as currently there are no approved treatments for moderate to severe VMS that can be used by these patients,” said Marci English, vice president and head of biopharmaceutical development at Astellas, in a press release.

Fezolinetant is an investigational, oral, nonhormonal compound. In May 2023, the FDA approved the agent for the treatment of moderate to severe VMS, or hot flashes, caused by menopause.² The safety and efficacy of the agent have not yet been established in HIGHLIGHT 1’s intent-to-treat population.¹

Approximately 77% of breast cancers can be treated with adjuvant endocrine therapies. Hot flashes and night sweats are among the most prominent adverse effects (AEs) of these agents.¹

About the HIGHLIGHT 1 Study

HIGHLIGHT 1 is currently enrolling patients across 3 sites in Quebec, Canada.³ The study’s primary end points are changes in frequency and severity of VMS from baseline at 4 and 12 weeks. Secondary end points include incidence of treatment-emergent AEs, AEs of special interest, laboratory value abnormalities, vital sign abnormalities, mammogram or breast ultrasound abnormalities, and pharmacokinetics.

Patients will be randomized to receive fezolinetant or placebo once daily for 52 weeks. Female patients with a history of stage 0 to III hormone receptor-positive, HER2-positive or HER2-negative breast cancer receiving stable maintenance therapy of tamoxifen (Soltamox) or an aromatase inhibitor are eligible for enrollment in the study. Additionally, patients must have a minimum average of 7 moderate to severe VMS per day, an ECOG performance status of 0 or 1, a minimum 12-month life expectancy, and have no new clinically significant findings on breast examination or from imaging.

Those with history of metastatic breast cancer or any malignancy other than breast cancer or basal cell carcinoma with less than 5 years of complete remission are not eligible for study participation.

The study plans to randomize approximately 540 patients at up to 100 sites globally.¹ The estimated study completion date is August 31, 2027.³

REFERENCES:

1. Astellas initiates phase 3 clinical study of fezolinetant for VMS in women with breast cancer receiving adjuvant endocrine therapy. News release. Astellas. August 27, 2024. Accessed August 28, 2024. https://tinyurl.com/bdrtz3uj

2. FDA approves novel drug to treat moderate to severe hot flashes caused by menopause. News release. FDA. May 12, 2023. Accessed August 28, 2024. https://tinyurl.com/v3bdetth

3. A study to confirm if fezolinetant helps reduce hot flashes in women with breast cancer who are having hormone therapy. ClinicalTrials.gov. Updated August 21, 2024. Accessed August 28, 2024. https://clinicaltrials.gov/study/NCT06440967