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Testing a New Treatment Combining Chemotherapy and Radiation Before Surgery for Advanced Triple-Negative Breast Cancer

Neoadjuvant Concurrent Chemoradiation Therapy in the Locally Advanced Triple-Negative Breast Cancer Population: A Prospective Clinical Trial - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079814
Enrollment
44
Registered
2025-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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: Neoadjuvant chemoradiation in locally advanced triple negative breast cancer patients: 4 cycles of 3 weekly chemotherapy with anthracycline cyclophosphamide followed by 12 weekly cycles

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Biopsy proven unilateral locally advanced triple negative breast cancer which includes Stage IIIA-C &/or oligometastastic disease which is defined by ESTRO/ESMO/ACOG as a disease with up to 5 lesions each amenable to local therapy aimed at achieving no evidence of disease status.

Exclusion criteria

Exclusion criteria: Unwilling for mastectomy, previous irradiation to chest wall, multiple visceral/bone metastasis, renal cardiac dysfunction, uncontrolled diabetes, bilateral breast cancer, recurrence of tumour

Design outcomes

Primary

MeasureTime frame
To assess the tolerability of treatment regimenTimepoint: Patient will be assessed at baseline, during time of chemoradiation, post surgery,and after treatmet at 6 weeks, 8 weeks and 12 weeks

Secondary

MeasureTime frame
To assess pathological complete response rate (pCR)Timepoint: pCR report will be available only post surgery (after completion of treatment i.e Neoadjuvant chemoradiation followed by modified radical mastectomy) single time point

Countries

India

Contacts

Public ContactJahnabi Das

Dr B Borooah Cancer Institute

jahnabi.das@bbci.in6901269033

Outcome results

None listed

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