NCT06926543

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 858 (estimated)
• Sponsor: Dr. Tabassum Wadasadawala · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions: 1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival? 2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)? 3. What are each treatment approach's financial costs? Researchers will compare the following to groups: Arm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation. and Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy. Participants are going to: 1. Get the usual chemotherapy (taxanes and/or anthracyclines). 2. Receive radiation therapy for three to four weeks. 3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.

Conditions

• Invasive Breast Cancer
• Stage III Breast Cancer
• Stage IIB Breast Cancer

Interventions

Type	Name	Description
DRUG	Chemoradiation	This intervention will consist of getting chemotherapy followed by radiotherapy, i.e, in a sequential manner
DRUG	Chemoradiation	This intervention will consist of getting chemotherapy and radiotherapy at the same time, i.e, in a concurrent manner.

Timeline

• Start date: 2024-05-14
• Primary completion: 2031-05-01
• Completion: 2031-05-01
• First posted: 2025-04-13
• Last updated: 2025-04-13

Locations

5 sites across 1 country: India