A study to assess the response of Radiotherapy in Inoperable Breast Cancer Patients not responding to Preoperative Chemotherapy.

A prospective study to determine the disease response to Radiotherapy (34Gy/10 fractions) in patients of Inoperable Carcinoma breast not responding to Neo-Adjuvant Chemotherapy and factors influencing it. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100098

Enrollment

Registered

2026-01-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Hypo-fractionated Radiotherapy: Hypo-fractionated Radiotherapy with 34 Grey in 10 fractions to PTV, one fraction a day, 5 fractions a week, over 2 weeks. Control Intervention1: NIL: NI

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed locally advanced or recurrent breast carcinoma deemed inoperable. 2. Patients unsuitable for surgery due to comorbidities, or patient refusal,3. Age: more than 18years. 4. ECOG performance status 0-3. 5. Stage of the disease T3/4, N positive, M positive or negative. 6. Patients not responding to neoadjuvant chemotherapy 7. Normal baseline complete blood counts, liver function tests, renal function tests, blood sugar. 8. Patients who have received cardiological clearance with normal ECG and 2D Echocardiography scans 9. Signed informed consent by the patient to participate in the study including willingness to join the novel treatment approach.

Exclusion criteria

Exclusion criteria: 1. Prior radiation therapy to the same breast or chest wall 2. Pregnant or lactating women. 3. Evidence of uncontrolled co-morbidities e.g. uncompensated respiratory, cardiac, hepatic and renal issues. 4. Refusal to undergo radiation therapy 5. Any other malignancy in past 5 years 6. Patients with visceral crisis. 7. Participation in any other interventional study on breast carcinoma.

Design outcomes

Primary

Measure	Time frame
Evaluated based on the change in acute and late toxicity profiles before and after completion of radiotherapy.Timepoint: 6 weeks	—

Secondary

Measure	Time frame
1. Disease response in terms of Clinical assessment by Investigators 2. Toxicity assessment as per RTOG criteriaTimepoint: 6 weeks	—

Countries

India

Contacts

Public ContactDr Chandrima Banerjee

Institute of Post Graduate Education and Research Kolkata

chandrimab14@gmail.com9433824243

Outcome results

None listed

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