Neoadjuvant Goserelin for Triple Negative Breast Cancer — NeoGONT  

Breast Cancer Triple Negative Clinical Trial

Official title: Prospective Phase II Randomized Trial of Evaluating the Effect of Adding LHRH Analogue to the Neoadjuvant Chemotherapy Treatment of Triple Negative Breast Cancer on Pathologic Complete Response (pCR) Rates

Status Not yet recruiting

Clinical Trial Summary

This is a phase II randomized trial that will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy to patients with triple negative breast cancer. Targeting LHRH might decrease resistance to chemotherapeutic agents in the neoadjuvant setting and increases clinical and pathological response rates. Additionally, exploring potential surrogate markers (as AR and LHRH receptors) for molecular distinct subtypes of TNBC.

Clinical Trial Description

Neoadjuvant chemotherapy (NACT) is the mainstay of treatment of locally advanced TNBC and some selected early cases followed by surgery with or without adjuvant radiotherapy. NACT is aimed to induce pathologic complete response (pCR) in tumor and lymph nodes, pCR is proofed to be a surrogate and reliable predictive factor of survival rates in TNBC. This study will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy. Following completion of neoadjuvant therapy, patients will undergo breast conservative surgery or mastectomy. Post-neoadjuvant chemotherapy axillary staging will be required, but the choice of the procedure will be at the physician's discretion. Postoperative radiation therapy will be given at the physician's discretion. The use of partial breast irradiation techniques will not be allowed. The primary endpoint will be the rate of pathologic complete response. The secondary endpoints will be 3-year-disease free survival, clinical response and toxicity. Exploratory endpoints will be correlation of the LHRH receptor expression level with the pCR. The sample size for the trial will be 180 patients accrued over a period of 2 years. Definitive analysis of the primary endpoints is expected at year 3. ;

Related Conditions & MeSH terms

• Breast Cancer Triple Negative
• Breast Neoplasms
• Triple Negative Breast Neoplasms

• NCT number: NCT03444025
• Study type: Interventional
• Source: Kasr El Aini Hospital
• Contact: Kyrillus S Shohdy, MD
• Phone: 02 01229961016
• Email: shohdyks@residents.kasralainy.edu.eg
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2018
• Completion date: March 2023