Efficacy of Neoadjuvant Endocrine Therapy Compared to Chemotherapy in Breast Cancer Patients

Female Breast Cancer Clinical Trial

Official title: Efficacy of Endocrine Therapy Compared to Chemotherapy as a Neoadjuvant Treatment for Patients With Hormone Receptor-positive and HER2-negative Breast Cancer.

Status Not yet recruiting

Clinical Trial Summary

Eligible patients will be divided into two groups; one will receive neoadjuvant endocrine therapy and the other one will receive neoadjuvant chemotherapy.

Clinical Trial Description

Patients will be randomized into two groups:

The first group (Arm A) will receive NCT; (Any approved Chemotherapy protocol by guidelines.

The second group(Arm B) will receive NET; GnRH analog Goserelin acetate 3.6 mg every 4 weeks with tamoxifen 20 mg daily for premenopausal patients or an aromatase inhibitor for postmenopausal patients.

• Before and during treatments (every 3 weeks for the NCT group, and every 4 weeks for the NET group), the clinical assessment will be performed for all patients.

• All patients will undergo breast magnetic resonance imaging (MRI) before the start of treatment, after 12 weeks (3 months) of treatment, and after the end of treatment before surgery.

• We will determine the objective tumor response with every measurement method and assess the response according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1.

• Treatment will be continued for 19-21 weeks before surgery for the chemotherapy group and 24 weeks for the endocrine therapy group.

• Ki-67 will be assessed using a sample of the core biopsy before treatment and a surgery specimen after treatment.

• Adverse events will be recorded at every patient visit and will be assessed according to the Common Terminology Criteria for Adverse Events Version 5.0.

• Surgery will be performed between the 24th and 26th week.

• Arm B Patients who will develop PD or SD after 6 months of treatment will be shifted to arm A.

The primary endpoint will be;

• The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements.

• A clinical response included either a complete response (CR), a partial response (PR), Progressive Disease (PD), or Stable Disease (SD) according to the (RECIST) version 1.1.

Secondary endpoints will be;

• The rate of pathological complete response (pCR).

• The rate of breast conservation surgery.

• Ki-67 changes.

• The length of time to maximum response within a treatment period.

• The Adverse events associated with each treatment arm. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Female Breast Cancer

• NCT number: NCT05755581
• Study type: Interventional
• Source: Sohag University
• Contact: Amal Ali, MD
• Phone: 01010454426
• Email: amal_ali@med.sohag.edu.eg
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2023
• Completion date: August 1, 2025