To study if it is safe to avoid drugs that prevent fall in neutrophil counts in blood during paclitaxel chemotherapy.

Avoiding prophylactic growth factors during paclitaxel phase of dose dense adjuvant chemotherapy in breast cancer ?

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/03/041308

Enrollment

118

Registered

2022-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: PEG GCSF : PEG GCSF Dose: 6 mg/ 3 weekly Route: Subcutaneous Duration 6 months Control Intervention1: Peg GCSF: Peg GCSF Dose: 6 mg/ 3 weekly Route: Subcutaneous Duration 6 months

Eligibility

Inclusion criteria

Inclusion criteria: Women/men with stage I-III breast cancer 1. Age group between 18-65 years 2. Eastern Cooperative Oncology Group performance status of 0-1 3. Absolute neutrophil count (ANC) > 1,500/ mL, haemoglobin > 9.0 g/dL, platelets >100,000/mL 4. Normal hepatic and renal function

Exclusion criteria

Exclusion criteria: 1. Patients who had febrile neutropenia during AC chemotherapy. Febrile neutropenia is defined as a single oral temperature measurement of >101Â°F or a temperature of â?¥100.4Â°F (â?¥38.0Â°C) sustained over 1 hour, with an absolute neutrophil count (ANC) of cells/microliter, or an ANC that is expected to decrease to next 48 hours. 2. Recipient of prior cytotoxic chemotherapy (e.g. in case of metachronous breast cancer) 3. Patients with HIV, hepatitis B or C infection

Design outcomes

Primary

Measure	Time frame
Completion rate of paclitaxel by omitting prophylactic peg GCSFTimepoint: Post 4 cycles of chemotherapy	—

Secondary

Measure	Time frame
1. Actual usage of peg GCSF ( percentage of patients who will require GCSF) 2. Hematological toxicities (Neutropenia, FN) 3. Non-hematological toxicities 4. Patient Reported Outcomes â?? to be assessed every cycle 5. Quality of life â?? to be assessed at cycle 1 and at cycle 4 of paclitaxel 6. Decrease in bone pains 7. Reduction in cost of treatment 8. Reduction in hospital visits Timepoint: Post 4 cycles of chemotherapy	—

Measure

Time frame

1. Actual usage of peg GCSF ( percentage of patients who will require GCSF) 2. Hematological toxicities (Neutropenia, FN) 3. Non-hematological toxicities 4. Patient Reported Outcomes â?? to be assessed every cycle 5. Quality of life â?? to be assessed at cycle 1 and at cycle 4 of paclitaxel 6. Decrease in bone pains 7. Reduction in cost of treatment 8. Reduction in hospital visits Timepoint: Post 4 cycles of chemotherapy

—

Countries

India

Contacts

Public ContactYogesh Kembhavi

Tata Memorial Centre

drseemagulia@gmail.com02224177201

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026