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

Phase 1

Not yet recruiting

• Conditions: Female Breast Cancer
• Interventions: Drug: Hormonal Antineoplastics; Drug: Chemotherapy drug

• Registration Number: NCT05755581
• Lead Sponsor: Sohag University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Study First Posted: 2023-03-06
• Last Update Posted: 2023-03-06
• Study Start: 2023-04-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant endocrine therapy group	Hormonal Antineoplastics	Patients in this group will receive neoadjuvant endocrine therapy
Neoadjuvant chemotherapy group	Chemotherapy drug	Patients in this arm will receive neoadjuvant chemotherapy as usual

Primary Outcome Measures

Name	Time	Method
Clinical response rate	6 months	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.

Secondary Outcome Measures

Name	Time	Method
pathological complete response	6 months	The rate of pathological complete response after surgery.

Trial Locations

Locations (1)

amal Ali; 🇪🇬 Sohag, Egypt