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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Female Breast Cancer
• Intervention / Treatment: Drug: Chemotherapy drug; Drug: Hormonal Antineoplastics

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: amal Ali, MD; Phone Number: 01010454426; Email: amal_ali@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 02
    • amal Ali
    • Contact: amal Ali, MD; Phone Number: 01010454426; Email: amal_ali@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Any histological type of invasive breast cancer. All grades of breast cancer (I, II, III). ER-positive and/or PR-positive, HER2-negative breast cancer. ER and/or PR level of positivity ≥34 % (score 4 according to modified Allred score).

Clinical Stages: any T N1-3, or T2-4 any N, M0.

Exclusion Criteria:

• Hormone receptor positivity < 34%. inflammatory breast cancer Metastatic breast cancer. Recurrent breast cancer. Other malignancy. Unfit patients for chemotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neoadjuvant chemotherapy group; Patients in this arm will receive neoadjuvant chemotherapy as usual	Drug: Chemotherapy drug; the Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy.
Active Comparator: Neoadjuvant endocrine therapy group; Patients in this group will receive neoadjuvant endocrine therapy	Drug: Hormonal Antineoplastics; the Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response rate	The primary endpoint will be; The clinical response rate at the end of neoadjuvant treatment, as will be determined using caliper and MRI measurements according to the (RECIST) version 1.1.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological complete response	The rate of pathological complete response after surgery.	6 months

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Amal Ali, MD, assistant lecturer

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Neoadjuvant endocrine therapy ,neoadjuvant chemotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Hormonal
• Other Study ID Numbers: Soh-Med-23-02-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No