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A study to look at the effects of combining chemotherapy and radiation treatments in advanced breast cancer

Concurrent chemo-radiotherapy with paclitaxel in locally advanced breast cancer: prospective observational data collection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/031320
Enrollment
200
Registered
2021-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast

Interventions

Intervention1: nil: nil

Sponsors

Cancer Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.All female patients with locally advanced carcinoma breast who are planned for CTRT with paclitaxel as neoadjuvant modality of treatment after multi-speciality board discussion. 2.The following stages as per AJCC TNM staging will be considered as LABC (IIIA, IIIB and IIIC). Except patients with T4a tumors (chest wall fixity). 3.Age between 18 to 65 years 4.Karnofsky performance status score >=70 5.Normal cardiac function with echocardiography showing Ejection Fraction (EF) > 50%

Exclusion criteria

Exclusion criteria: 1.Patients with metastatic disease 2.Patients with chest wall fixity of tumor, as they are not considered for surgery after completion of neoadjuvant treatment. 3.Inflammatory breast cancer. 4.Male breast cancer 5.Patients deemed inoperable at presentation due to factors like lymphedema, chest wall fixity or cutaneous nodules extending beyond the confines of the breast. 6.SGOT (AST) > 2.0 x upper limit of normal (ULN) and SGPT (ALT) >2.0 x ULN and Bilirubin >1.5 x ULN 7.Serum creatinine > ULN 8.Patient has received prior radiotherapy to the affected breast 9.Patients with uncontrolled diabetes mellitus, hypertension or ischemic heart disease. 10.Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry. 11.Hypersensitivity to paclitaxel 12.Grade 2 or more peripheral neuropathy 13.Patient not consenting for treatment

Design outcomes

Primary

MeasureTime frame
To assess the pathological response rate with CTRT in LABCTimepoint: Till completion of surgery—

Secondary

MeasureTime frame
To assess toxicity of CTRT in LABC To assess event free survival (EFS) with use of CTRT in LABC. Timepoint: During treatments and at the end of 5 years—

Countries

India

Contacts

Public ContactPriya Iyer

Cancer Institute

priyaonc@gmail.com09498082772

Outcome results

None listed

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