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

National Cancer Institute, Egypt

Status: Completed

Conditions: Breast Cancer Female

Treatments: Radiation: neoadjuvant chemoradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT06631066

RO2109-30909

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

neoadjuvant chemotherapy arm

No Intervention group

Description:

The patients in this arm will recieve neoadjuvant chemotherapy (with anti-her2 agents if indicated) according to the national guidelines. post systemic treatment imaging will be done to assess the response, followed by surgery as indicated. Adjuvant radiotherapy as well as hormonal or target therapy will be prescribed as indicated. Radiation therapy will be delivered in hypofractionated course (40.05 Gray over 15 fractions with boost to tumor bed 10 Gray over four fractions) to the breast/ chestwall as well as regional lymphatics.

Neoadjuvant chemoradiation arm

Experimental group

Description:

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.

Treatment:

Radiation: neoadjuvant chemoradiation