NCT05150652

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Irada Ibrahim-zada · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.

Conditions

• Breast Cancer
• HER2-negative Breast Cancer
• Node-negative Breast Cancer
• Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Anastrozole 1mg	Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.
DRUG	Letrozole 2.5mg	Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.
DRUG	Exemestane 25 mg	Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.
DRUG	Tamoxifen	Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.

Timeline

• Start date: 2022-02-18
• Primary completion: 2025-12-09
• Completion: 2026-06-09
• First posted: 2021-12-09
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study