Effect of Neoadjuvant Chemoradiation on Pathologic Complete Response Rates in Locally Advanced Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Cancer Female
• Interventions: Radiation: neoadjuvant chemoradiation

• Registration Number: NCT06631066
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

This is a phase II randomized trial comparing pathologic complete response rates in locally advanced patients recieving either neoadjuvant chemotherapy or neoadjuvant chemoradiation.

Detailed Description

A prospective randomized phase II trial, that enrolled locally advanced breast cancer patients who were randomized to recieve either neoadjuvant systemic treatment or neoadjuvant systemic treatment concurrently with radiotherapy. Surgery is done for all patients later on as indicated.

The pathological response rates between both groups will be compared, as well as surgical complications and acute radiation toxicity.

Study Timeline

• Study Start: 2021-10-20
• Primary Completion: 2023-10-10
• Study Completion: 2024-07-15
• Study First Submitted: 2024-08-13
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-06
• Last Update Submitted: 2024-10-06
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

1. Female patients.

2. Age: 21 years or older.

3. ECOG performance status (PS) score 0 to 2.

4. Locally advanced tumors (stage IIIA or above) of any subtype.

5. Early breast cancer of the HER2+ or TNBC subtype when:

   1. Node-negative, T2 or T3.
   2. Node-positive, any T stage.

Exclusion Criteria

1. Patients initially presenting with metastatic breast cancer.
2. Patients unfit to receive planned regimen of treatment that had a poor PS (i.e.: PS 3 and 4).
3. Inflammatory breast cancer (T4d) patients.
4. Patients having contraindications to radiotherapy (e.g.: Pregnancy, history of previous chest wall, breast, or axillary irradiation)
5. History of previous ipsilateral breast surgery.
6. Comorbidities that would affect skin healing or integrity, like uncontrolled diabetes mellitus or active autoimmune collagen or vascular diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemoradiation arm	neoadjuvant chemoradiation	The patients in this arm will recieve neoadjuvant chemotherapy with preoperative radiotherapy concurrently with taxanes. Surgery is done 6-8 weeks as indicated, followed by systemic treatment according to the guidelines.

Primary Outcome Measures

Name	Time	Method
pathologic complete response rates	1 week postoperative	the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system

Secondary Outcome Measures

Name	Time	Method
acute radiation toxicity	during radiation therapy: week 2,3,4. weekly after the end of radiation therapy for 4 weeks	radiation therapy oncology group (RTOG) acute morbidity score

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt