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

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

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.

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