Study Title - Phase 1/2 study of the efficacy 3 mg Peg GCSF in adjuvant and/or neoadjuvant dose dense breast cancer treatment protocols.
Phase 1
- Conditions
- Health Condition 1: C501- Malignant neoplasm of central portion of breast
- Registration Number
- CTRI/2021/07/034751
- Lead Sponsor
- Abhishek Pathak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Newly diagnosed female patients with invasive ductal carcinoma breast requiring neoadjuvant or adjuvant dd-AC/EC protocol.
Exclusion Criteria
1.Previous exposure to chemotherapy or radiotherapy.
2.Patients suffering from other causes of myelosuppression (aplastic anemia, drug related, viral infection)
3.HbsAg or anti HCV positive patients.
4.Uncontrolled diabetes mellitus, HbA1C > 7.5 g%
5.History of severe Covid in last 06 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of 3 mg Peg GCSF in adjuvant and or neoadjuvant dose dense breast cancer treatment protocolTimepoint: 3 and 7 day after Peg GCSF
- Secondary Outcome Measures
Name Time Method Efficacy of 3 mg Peg GCSF in adjuvant and or neoadjuvant dose dense breast cancer treatment protocolTimepoint: 0 , 3 7 days post chemotherapy