Breast Cancer Female
Conditions
Keywords
preoperative radiotherapy, locally advanced breast cancer, pathologic response
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.
Interventions
RADIATIONneoadjuvant chemoradiation
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.
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathologic complete response rates | 1 week postoperative | the pathologic response will be measured by the Randomized cancer burden (RCB) scoring system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed