To see the effect of combined injections and radiation therapy along with special injections called immunotherapy on the outcome of breast cancers which are hormone receptor negative
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2024/02/062372
- Lead Sponsor
- Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. All female patients with Stage II and III TNBC who are planned for neoadjuvant modality of treatment after multispeciality board discussion.
2. Age between 18 to 70 years
3. Karnofsky performance status score greater than or equal to 70
4. Normal cardiac function with echocardiography showing Ejection Fraction (EF) greater than 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. Male breast cancer
4. Patients deemed inoperable at presentation due to factors like lymphedema, chest wall fixity or cutaneous nodules extending beyond the confines of the breast.
5. SGOT (AST) greater than 2.0 times upper limit of normal (ULN) and SGPT (ALT) greater than 2.0 times ULN and Bilirubin greater than 1.5 times ULN
6. Serum creatinine greater than ULN
7. Patient has received prior radiotherapy to the affected breast
8. Patients with uncontrolled diabetes mellitus, hypertension or ischemic heart disease.
9. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
10. Hypersensitivity to paclitaxel
11. Grade 2 or more peripheral neuropathy
12. Patients with known auto-immune conditions
13. Patient not consenting for treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete responseTimepoint: After surgery
- Secondary Outcome Measures
Name Time Method To assess the levels of ctDNA at baseline and after the completion of neoadjuvant treatments and corelate it with the pathological response in the surgical specimen specimen.Timepoint: At Baseline and after completion of neoadjuvant treatments before surgery;To assess the quality of life among the four armsTimepoint: All patients will be assessed at baseline, prior to surgery and 6 months post-surgery. This will be compared to the QOL of patients in the standard arm.;Tolerance and toxicityTimepoint: During the course of Neoadjuvant chemotherapy, immunotherapy and concurrent radiation