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 1/2 study of the efficacy 3 mg Peg GCSF in adjuvant and/or neoadjuvant dose dense breast cancer treatment protocols.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/034751

Enrollment

Registered

2021-07-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C501- Malignant neoplasm of central portion of breast

Interventions

Intervention1: Inj Peg GCSF 3mg: Inj Peg GCSf would be given to all patients 6 hrs after recieving dose dense AC protocol for breast cancer every 2 weekly Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed female patients with invasive ductal carcinoma breast requiring neoadjuvant or adjuvant dd-AC/EC protocol.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Efficacy of 3 mg Peg GCSF in adjuvant and or neoadjuvant dose dense breast cancer treatment protocolTimepoint: 0 , 3 7 days post chemotherapy	—

Countries

India

Contacts

Public ContactAbhishek Pathak

room no 301, Department of Medical oncology ,Command Hospital , Kolkata

drabhipat@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026