NCT07407517

Adjuvant Intensification for LAR

Standard Chemotherapy Plus Oral Everolimus as Adjuvant Therapy for LAR Breast Cancer Patients: A Randomized, Open-Label, Phase III Trial （POLARIS）

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 904 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study enrolled patients with early-stage triple-negative breast cancer who had undergone radical surgery. The postoperative pathology met the TNM staging criteria of pT1c-3N0-3M0, and immunohistochemistry (IHC) results confirmed ER-negative status (IHC showed \<1% of tumor cells positive for ER), PR-negative status (IHC showed \<1% of tumor cells positive for PR), and HER2-negative status (IHC intensity of 0 or 1+; or IHC intensity of 2+ but with negative in situ hybridization results). Additionally, patients either exhibited high AR expression (IHC showing AR ≥10%) or were classified as the LAR subtype based on digital pathology. This study plans to prospectively enroll 904 subjects, who will be randomized in a 1:1 ratio after completing standard chemotherapy. They will be allocated to either the standard-of-care (SOC) chemotherapy followed by everolimus group or the SOC-alone group. The study aims to evaluate the efficacy of SOC chemotherapy followed by everolimus versus SOC chemotherapy alone as adjuvant therapy for patients with early-stage radically resected triple-negative breast cancer of the LAR subtype, with the primary endpoint being 3-year invasive disease-free survival (iDFS).

Conditions

• Breast Cancer Females
• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	Everolimus 10 mg daily	After completion of standard chemotherapy, everolimus at a fixed dose of 10 mg orally once daily continuously for a duration of 1 year.

Timeline

• Start date: 2026-02-01
• Primary completion: 2033-02-01
• Completion: 2033-02-01
• First posted: 2026-02-12
• Last updated: 2026-02-12