Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer — NeoChAI  

Breast Cancer Clinical Trial

Official title: Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer

Status Recruiting

Clinical Trial Summary

This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.

Clinical Trial Description

STUDY RATIONALE: Patients with ER+/HER2- operable breast cancers who are candiate of neoadjuant chemotherapy generally receive chemotherapy alone before operation, followed by adjuvant endocrine therapy. Because endocrine therapy is primarily delivered in the postoperative setting, the ability to add the efficacy of aromatase inhibitors combined with chemotherapy is lost. This study offers the unique opportunity to assess the synergistic or additive responsiveness of breast tumors to endocrine therapy plus chemotherapy while the tumors are still in vivo by treating patients with an aromatast inhibitor combined with chemotherapy before surgery and assessing pCR rates.

PRIMARY OBJECTIVE: The primary objective is to determine the frequency of pCR in breast and axilla. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Invasive Breast Cancer

• NCT number: NCT03497702
• Study type: Interventional
• Source: National Cancer Center, Korea
• Contact: Keun Seok Lee, MD, PhD
• Phone: +82-31-920-1220
• Email: kslee@ncc.re.kr
• Status: Recruiting
• Phase: Phase 2
• Start date: May 8, 2017
• Completion date: January 2024