Evaluation of biomolecules to know cancer response in breast cancer patients
Not Applicable
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2022/06/043109
- Lead Sponsor
- ICMR Adhoc extramural grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Newly diagnosed triple-negative breast cancer.
Age 18 -65 years.
ECOG PS 0/1.
Early and locally advanced breast cancer (T2/T3/T4b with or without node positive).
Planned for neo-adjuvant chemotherapy with anthracycline and taxanes.
Bone marrow function- Hb > 9g%, absolute neutrophil count > 1500/ micL, platelet > 1.5 lakhs/ mic L.
Renal function- Serum creatinine < 1.5 mg%.
Liver function- Serum bilirubin > 1.5 mg%.
Normal cardiac function.Â
Exclusion Criteria
The patient is not willing to the second biopsy
Pregnant women
Breast feeding mother
Prior history of any other malignancy
Bilateral breast cancer
Patient having active local site infection
Previous allergy to chemotherapy drugs paclitaxel and carboplatin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The expected outcome from this project is to identify pathological, imaging, and molecular biomarker which would predict pCR in TNBC patients using the window period before NACT. <br/ ><br> <br/ ><br>We would develop a predictive score that will enable us to identify patients who will achieve pCR. This score needs to be validated in a larger population. <br/ ><br> <br/ ><br>Once validated we will prospectively use this score in a clinical trial setting to decide on chemotherapy intensity in TNBC patients planned for NACT. <br/ ><br>Timepoint: post neoadjuvant chemotherapy, at the end of the surgery
- Secondary Outcome Measures
Name Time Method disease free survivalTimepoint: post surgery followup of patients