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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05755581
• Other study ID #: Soh-Med-23-02-16
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: February 2023
• Source: Sohag University
• Contact: Amal Ali, MD
• Phone: 01010454426
• Email: amal_ali[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Female Breast Cancer

Intervention

Drug:
• Hormonal Antineoplastics
the Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy.
• Chemotherapy drug
the Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy.

Locations

Country	Name	City	State
Egypt	amal Ali	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pathological complete response	The rate of pathological complete response after surgery.	6 months