Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02480933 - Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens N/A
Not yet recruiting NCT04863833 - Tomosymthesis for Breast Mass Lesion Characterization
Completed NCT05000502 - Exercise, Gut Microbiome, and Breast Cancer: Increasing Reach to Underserved Populations N/A
Withdrawn NCT06145399 - A Study of 1 8F-FDHT PET/MRIScans in Women With Breast Cancer Early Phase 1
Suspended NCT01320488 - Breast Cancer in Young Women: Is it Different? N/A
Recruiting NCT02089854 - Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer Phase 4
Active, not recruiting NCT01741883 - Side Effect Prevention Training (SEPT) for Nocebo Effects in Breast Cancer Patients N/A
Recruiting NCT06144164 - A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer Phase 3
Recruiting NCT06331793 - Pulsed Electromagnetic Fields for Analgesia Post Mastectomy N/A
Recruiting NCT05439499 - This is a Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole ± Goserelin in Women With HR+ and HER2- Advanced Breast Cancer. Phase 3
Terminated NCT03836872 - Acupuncture for Joint Symptoms in Patients With Breast Cancer N/A
Recruiting NCT06332976 - PrefeRences And ChemoTherapy In Breast Cancer patiEnts
Completed NCT01671319 - Dose Dense TC + Pegfilgrastim Support for Breast Cancer Phase 2
Not yet recruiting NCT06092892 - IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases Phase 2
Recruiting NCT05586256 - Ultra-hypofractionated Radiotherapy in Breast Cancer Patients
Not yet recruiting NCT03153631 - Female Sexual Dysfunction in Breast Cancer Patients N/A
Active, not recruiting NCT03059875 - Place of Comprehensive Geriatric Assessment in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter) N/A
Active, not recruiting NCT02088710 - Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer N/A
Terminated NCT01083641 - Estrogen for Triple Negative Breast Cancer Phase 2
Recruiting NCT05374161 - An Intervention for Female Breast CANcer: Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain N/A