The effect of Pegfilgrastim on treatment of anemia consequent taxans chemotherapy in breast cancer patients

A Non-randomized, Single-armed Clinical trial study to determine the therapeutic efficacy of Pegfilgrastim (CinnaGen Company) to treatment of anemia consequent taxans chemotherapy in breast cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017012121315N7

Enrollment

Registered

2017-03-12

Start date

2012-08-09

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Condition 1: Breast Cancer. Condition 2: Neutropenia. Malignant neoplasm of breast of unspecified site Neutropenia

Interventions

Treatment - Drugs

CinnaGen Pegfilgrastim (Prefilled syringe: 6 mg / 0.6 ml for SC Injection,Single Dose Every Two Weeks for 24 months)

CinnaGen Pegfilgrastim (Prefilled syringe: 6 mg / 0.6 ml for SC Injection,Single Dose Every Two Weeks for 24 months).

Eligibility

Sex/Gender

Female

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: breast cancer stage I-III and women between the age of 18-65 years at the time of signing the informed consent form. Exclusion criteria: patients with metastatic breast cancer; liver failure or myelosuppression; pregnancy or lactation and dissatisfaction.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pegfilgrastim efficacy at grade 3 and 4 neutropenia from second cycle at chemotherapy regimen include taxans at breast cancer. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Cell Blood Count (CBC).	—

Secondary

Measure	Time frame
Determining the frequency of grade 3 and 4 neutropenia. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Cell Blood Count (CBC).;Determining the frequency of bone pain. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: patient assessment.;Determining the frequency of injection site pain. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: patient assessment.;Determining the frequency of injection site reaction. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Physician assessment.;Determining the frequency of thrombocytopenia. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: CBC (Cell Blood Count).;Determining the frequency of febrile neutropenia. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Physician assessment.;Determining the frequency of hospitalization. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Physician assessment.	—

Measure

Time frame

Determining the frequency of grade 3 and 4 neutropenia. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Cell Blood Count (CBC).;Determining the frequency of bone pain. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: patient assessment.;Determining the frequency of injection site pain. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: patient assessment.;Determining the frequency of injection site reaction. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Physician assessment.;Determining the frequency of thrombocytopenia. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: CBC (Cell Blood Count).;Determining the frequency of febrile neutropenia. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Physician assessment.;Determining the frequency of hospitalization. Timepoint: Every two weeks until two weeks after the last dose of pegfilgrastim. Method of measurement: Physician assessment.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRamin Azhdarzadeh

Orchid Pharmed Company

azhdarzadeh.m@orchidpharmed.com+98 21 8808 8821

Outcome results

None listed

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