Postoperative radiotherapy in breast cancer- Chemotherapy and radiotherapy given simultaneously or chemotherapy followed by radiotherapy.

Phase III randomized controlled trial of sequential chemotherapy & radiotherapy versus concurrent chemoradiotherapy in adjuvant treatment of breast cancer. - CONCERT

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054280

Enrollment

858

Registered

2023-06-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: sequential chemotherapy and radiotherapy: adjuvant chemotherapy depending upon the stage followed by standard radiotherapy as appropriate for the stage of cancer and as per institutiona

Eligibility

Inclusion criteria

Inclusion criteria: 1.Pathologically confirmed invasive breast cancer 2.Clinical stage IIB-III invasive breast cancer (AJCC 8th edition) 3.Patients planned for adjuvant chemotherapy and adjuvant radiotherapy after curative-intent surgery 4.Patient fit to receive chemotherapy and radiotherapy 5.Age > 18 years

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to taxanes 2.Unable or unwilling for regular follow up 3.Bilateral tumour needing RT to both sides 4.Patients planned for RT to oligometastatic sites 5.Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/orlungs (Exceeding the protocol specific dose constraints). 6.Pregnant patient.

Design outcomes

Primary

Measure	Time frame
To demonstrate the superiority of concurrent CTRT regimen in adjuvant treatment of breast cancer with respect to disease free survival.Timepoint: Study the 3-year Disease Free Survival.	—

Secondary

Measure	Time frame
1. To study impact of concurrent regimen on patient Quality of life. Timepoint: Pre-RT, Post-RT, 1, 2, 3 yrs;2. To assess cosmesis in breast conservation surgery patientsTimepoint: Pre-RT, Post-RT,1, 2, 3 years;3. To study the impact on Health economics in the two armsTimepoint: Pre-RT, Post-RT;4. Disease related outcomes of concurrent CTRT in terms of overall survival (OS), locoregional failure-free survival (LRFFS) & breast cancer specific survival (BCSS).Timepoint: 3 years	—

Measure

Time frame

1. To study impact of concurrent regimen on patient Quality of life. Timepoint: Pre-RT, Post-RT, 1, 2, 3 yrs;2. To assess cosmesis in breast conservation surgery patientsTimepoint: Pre-RT, Post-RT,1, 2, 3 years;3. To study the impact on Health economics in the two armsTimepoint: Pre-RT, Post-RT;4. Disease related outcomes of concurrent CTRT in terms of overall survival (OS), locoregional failure-free survival (LRFFS) & breast cancer specific survival (BCSS).Timepoint: 3 years

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Countries

India

Contacts

Public ContactDr Tabassum Wadasadawala

Tata Memorial Centre, Mumbai

twadasadawala@actrec.gov.in91-22-24177026

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026