To determine the effectiveness of CANScript, the anti-cancer drug sensitivity test in determining the most optimal drug combination for a cancer patient
- Conditions
- Health Condition 1: null- Neoadjuvant Head & Neck cancer or Triple Negative breast cancer
- Registration Number
- CTRI/2015/06/005943
- Lead Sponsor
- Mitra Biotech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 195
1. Patients with Ca-H&N requiring neo-adjuvant therapy or refractory/ relapsed triple negative breast cancer , aged 18-75 are eligible for the ACCEPT trial.
2. Patients from whom at least 100-200 mm3 non-necrotic tumor can be obtained by biopsy or surgery.
3.ECOG Performance Status of 0 - 1
4. Triple NEgative BReast cancer patients must be tested negative for ER, PR & HER2 receptor expression
Any other concurrent disease or illness, which in the judgment of the investigator would make the subject inappropriate for entry into the study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response to the anti-cancer drug administered by the investigator will be assessed by PET/CT imaging. CANScript outcome will be available for comparison of predicted and actual responseTimepoint: Clinical response for each patient will be recorded post 2 months from the date of enrolment. The clinical outcomes will be compared with CANScript outcomes of respective patient.
- Secondary Outcome Measures
Name Time Method Follow up phase for study of progression free survivalTimepoint: Up to 2 years from baseline visit or patient death whichever is early