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

NCT05755581 | Unknown Phase 1

• 1 other identifier: Soh-Med-23-02-16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Female Breast Cancer

Keywords

Neoadjuvant endocrine therapy ,neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pathological complete response

  6 months

Study Arms (2)

Neoadjuvant chemotherapy group

ACTIVE COMPARATOR

Patients in this arm will receive neoadjuvant chemotherapy as usual

Drug: Chemotherapy drug

Neoadjuvant endocrine therapy group

ACTIVE COMPARATOR

Patients in this group will receive neoadjuvant endocrine therapy

Drug: Hormonal Antineoplastics

Interventions

Hormonal Antineoplastics DRUG

the Neoadjuvant endocrine therapy group will receive neoadjuvant hormonal therapy.

Neoadjuvant endocrine therapy group

Chemotherapy drug DRUG

the Neoadjuvant chemotherapy group will receive neoadjuvant chemotherapy.

Neoadjuvant chemotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

amal Ali

Sohag, 02, Egypt

Location

MeSH Terms

Interventions

Antineoplastic Agents, Hormonal

Intervention Hierarchy (Ancestors)

Antineoplastic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Amal Ali, MD

  Assistant lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amal Ali, MD

CONTACT

01010454426; amal_ali@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 6, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 6, 2023

Record last verified: 2023-02

Locations

EG (1)