A pilot study of giving chemotherapy and radiotherapy concomitantly after breast cancer surgery

A Pilot Study of Concurrent Chemotherapy and Radiotherapy in Adjuvant Treatment of Breast Cancer (CONCERT) - CONCERT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017411

Enrollment

Registered

2019-02-04

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: Concurrent Chemoradiotherapy: Concurrent chemoradiotherapy in adjuvant treatment of breast cancer Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed invasive breast cancer 2. Stage II-III invasive breast cancer (AJCC 8th edition) 3. Patients planned for taxane-based adjuvant chemotherapy and adjuvant radiotherapy after curative-intent surgery irrespective of her2 status and receipt of anti-her2 therapy 4. Patients fit to receive taxane based chemotherapy 5. Age > 18 years 6. Willing to provide venous blood sample 7. Consent for photograhic assessment in case of breast conservation

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to taxanes 2. Patients meriting extended field radiotherapy (to internal mammary nodes and/or axillary nodes) 3. Bilateral breast cancer meriting radiotherapy to both sides 4. Unable or unwilling to give written informed consent 5. Unable or unwilling for regular follow up 6. Unfavourable anatomical factors potentially leading to higher radiotherapy dose to heart and/or lungs 7. Patient undergone immediate whole breast reconstruction 8. Patients receiving dose dense regimens. 9. Patients with prior irradiation of breast/mediastinum/neck 10. Pregnancy

Design outcomes

Primary

Measure	Time frame
To demonstrate the feasibility and safety of concurrent CTRT regimen in adjuvant treatment of breast cancer.Timepoint: Incidence of concurrent chemo-radiotherapy associated dose limiting toxicity will be assessed during as well as after treatment up to 3 months.	—

Secondary

Measure	Time frame
To assess the compliance rate and incidence of severe toxicity; To study impact of concurrent regimen on patient Quality of life; To compare severe acute toxicity rates of the two schedules of taxanes: 3 weekly and weekly; Short term disease related outcomes of concurrent CTRT in terms of overall survival (OS), loco-regional failure-free survival (LRFFS), breast cancer specific survival (BCSS) Timepoint: Study the impact of concurrent CTRT on global Quality of life scores up to 2 years post treatment; Disease free survival at 3 years; Breast cancer specific survival at 3 years; Overall survival at 3 years	—

Measure

Time frame

To assess the compliance rate and incidence of severe toxicity; To study impact of concurrent regimen on patient Quality of life; To compare severe acute toxicity rates of the two schedules of taxanes: 3 weekly and weekly; Short term disease related outcomes of concurrent CTRT in terms of overall survival (OS), loco-regional failure-free survival (LRFFS), breast cancer specific survival (BCSS) Timepoint: Study the impact of concurrent CTRT on global Quality of life scores up to 2 years post treatment; Disease free survival at 3 years; Breast cancer specific survival at 3 years; Overall survival at 3 years

—

Countries

India

Contacts

Public ContactDr Tabassum Wadasadawala

Tata Memorial Hospital, Mumbai

twadasadawala@actrec.gov.in02227405079

Outcome results

None listed

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