Comparing concurrent and sequential chemotherapy with radiation for breast cancer
Official title: Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)
Run by Tata Memorial Centre · NCT06926543 · Data updated 2026-11-12
This study is testing whether getting chemotherapy and radiation at the same time works better than getting them one after the other for people with stage IIB-III breast cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 858 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Vishkhapatnam, Andhra Pradesh and 4 other locations) |
| Status | Recruiting |
| Started | May 14, 2024 |
| Main results expected | May 2031 |
| Study ends | May 2031 |
| Registry record updated | April 13, 2025 |
| Trial ID | NCT06926543 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with pathologically confirmed stage IIB-III invasive breast cancer who are fit for adjuvant chemotherapy and radiotherapy.
✕Probably not a fit
Patients with hypersensitivity to taxanes, those who have received prior chemotherapy, or those with certain anatomical factors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical research aims to determine the effectiveness of concurrent chemotherapy and radiation therapy compared to sequential chemotherapy followed by radiation therapy in patients with stage IIB-III breast cancer. The study will evaluate disease-free survival rates, the impact on quality of life, side effects such as lymphoedema, and the financial costs associated with each treatment approach. Participants will receive standard chemotherapy and radiation therapy over a specified period, with follow-up assessments to monitor outcomes.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment regimen for improving survival and quality of life in breast cancer patients.
How similar studies have gone: Other studies have explored similar approaches in breast cancer treatment, indicating potential for success, though this specific comparison may be novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathologically confirmed invasive breast cancer 2. Stage IIB-III invasive breast cancer (AJCC 8th edition) 3. Patients planned for adjuvant chemotherapy and adjuvant radiotherapy 4. Patients fit to receive adjuvant chemotherapy and radiotherapy 5. Age \> 18 years Exclusion Criteria: 1. Hypersensitivity to taxanes 2. Patients receiving entire chemotherapy prior to surgery (neoadjuvant setting) 3. Unable or unwilling for regular follow up 4. Bilateral tumour needed RT to both sides 5. Patients planned for RT to oligometastatic sites 6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs (Exceeding the protocol specific mandatory dose constraints). 7. Pregnant patient
Where it's running
-
Tata Memorial Centre
Mumbai, Maharasthra, India Recruiting -
Homi Bhabha Cancer Hospital & Research Centre
Vishkhapatnam, Andhra Pradesh, India Not yet recruiting -
Homi Bhabha Cancer Hospital and Research Centre
New Chandigarh, Punjab, India Not yet recruiting -
Homi Bhabha Cancer Hospital, Sangrur
Sangrur, Punjab, India Not yet recruiting -
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Varanasi, Uttar Pradesh, India Not yet recruiting
Study contacts
- Study coordinator: Tabassum Wadasadawala, MD, DNB Radiotherapy
- Email: drtabs.radonc@gmail.com
- Phone: (+91-22) 24177026
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.