A study to look at the effects of combining chemotherapy and radiation treatments in advanced breast cancer
- Conditions
- Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast
- Registration Number
- CTRI/2021/02/031320
- Lead Sponsor
- Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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%
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the pathological response rate with CTRT in LABCTimepoint: Till completion of surgery
- Secondary Outcome Measures
Name Time Method To assess toxicity of CTRT in LABC <br/ ><br>To assess event free survival (EFS) with use of CTRT in LABC. <br/ ><br>Timepoint: During treatments and at the end of 5 years