Comparing concurrent and sequential chemotherapy with radiation for breast cancer
Phase III Randomized Controlled Trial of Sequential Chemotherapy and Radiotherapy Versus Concurrent Chemoradiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT)
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 |
| Enrollment | 858 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Vishkhapatnam, Andhra Pradesh and 4 other locations) |
| Trial ID | NCT06926543 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have explored similar approaches in breast cancer treatment, indicating potential for success, though this specific comparison may be novel.
Eligibility criteria
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 this trial is running
Vishkhapatnam, Andhra Pradesh and 4 other locations
- Homi Bhabha Cancer Hospital & Research Centre — Vishkhapatnam, Andhra Pradesh, India (Not_yet_recruiting)
- Tata Memorial Centre — Mumbai, Maharasthra, India (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.