Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Neoadjuvant concurrent chemoradiation: 4 cycles Paclitaxel and carboplatin with concurrent radiation to breast and nodal areas followed by 4 cycles Adriamycin and cyclophosphamide
Inter
Sponsors
Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 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%
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete responseTimepoint: After surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the levels of ctDNA at baseline & after the completion of neoadjuvant treatments & correlate it with the pathological response in the surgical specimen specimen. To do NGS at diagnosis on the biopsy.Timepoint: At Baseline & after completion of neoadjuvant treatments before surgery;To assess the quality of life, & patient reported outcomes between the two arms. To conduct a mixed method qualitative study.Timepoint: All patients will be assessed at baseline, prior to surgery & 6 months post-surgery.;Tolerance & toxicityTimepoint: During the course of Neoadjuvant chemotherapy, low dose nivolumab & concurrent radiation | — |
Countries
India
Contacts
Public ContactPriya Iyer
Cancer Institute
Outcome results
None listed