Phase III Randomized Trial Comparing Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Breast Cancer Treatment (CONCERT)

What this Trial Is About

Researchers are evaluating whether giving chemotherapy and radiation therapy at the same time (concurrent) is more effective than giving them one after the other (sequential) for patients with stage IIB-III invasive breast cancer. The study aims to find out if concurrent treatment improves disease-free survival, affects quality of life and side effects like arm swelling, and how the costs compare between these approaches. This is a Phase III randomized controlled trial sponsored by Dr. Tabassum Wadasadawala. Participants will be randomly assigned to one of two groups. One group will receive chemotherapy first, followed by radiation therapy (sequential treatment). The other group will receive chemotherapy and radiation therapy at the same time (concurrent treatment). Chemotherapy typically includes taxanes and/or anthracyclines, and radiation therapy will be given for three to four weeks. Both groups will follow these treatment schedules as part of their adjuvant therapy after surgery. During the study, participants will have follow-up visits every six months for five years to monitor cancer recurrence, side effects, and quality of life. Assessments will include disease-free survival over three years, quality of life questionnaires, cosmetic appearance after breast-conserving surgery, arm swelling (lymphedema) evaluations, and cost analysis of treatments. Overall survival and breast cancer-specific survival will also be tracked for up to five years to understand long-term outcomes.

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy