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

National Cancer Institute, Egypt160 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Breast Cancer Female

Interventions

neoadjuvant chemoradiationRADIATION

Neoadjuvant chemoradiation will be prescribed as: 4 cycles of Adriamycin and Cyclophosphamide followed by radiotherapy concurrently with taxanes/ taxanes and carboplatin. followed by surgery as indicated.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Cancer Institute

Cairo, Egypt

Outcomes

Primary Outcomes

pathologic complete response rates

the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system

Time frame: 1 week postoperative

Secondary Outcomes

acute radiation toxicity

radiation therapy oncology group (RTOG) acute morbidity score

Time frame: during radiation therapy: week 2,3,4. weekly after the end of radiation therapy for 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.