Skip to main content
OpenTrials
Completed

NCT Number: NCT03381417

Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.

Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 & day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical practice in Vietnam for breast cancer, this regimen is to facilitate the dose-dense schedule, patients receive every-2-week therapy along with G-CSF support. the accelerated dose-dense schedule improve disease-free and overall survival among women with breast cancer .Primary objective of this study is to compare the efficacy and safety of Nanogen's Pegcyte and Roche's Neulastim for prevention of chemotherapy (Accelerated AC regimen)-induced neutropenia on breast cancer patients. Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will be recruited in this trial. All eligible patients receive single subcutaneous injection of study drugs 24 hours after chemotherapy administration in each cycle for 3 consecutive cycles. Efficacy and safety assessments will be assessed based on the incidence of severe neutropenia in combination of temperature > 38.3℃ or sepsis or life threatening infection and incidence of serious adverse events.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Female

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Vietnam National Cancer Institute (Hospital K)

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged between 18 - 65 years.
  • Patients with histological confirmed primary invasive breast cancer; stage I, II or III.
  • Patients had no prior chemotherapy treatments.
  • Patients scheduled to undergo myelosuppressive Doxorubicin and Cyclophosphamide chemotherapy for 04 cycles, and Paclitaxel chemotherapy for the next 04 cycles; patients were available for 14 days of each cycle for the first 03 chemotherapy cycles.
  • Patients with baseline ANC ≥ 1.5 x 109/L, PLT ≥ 100 x 109/L, HgB ≥ 9 g/dL, WBC ≥ 3,000/mL and albumin ≥ 3.0 g/dL.
  • Performance status as per ECOG (Eastern Cooperative Oncology Group) score 0, 1 or 2.
  • Willing to give written and signed informed consent.

Exclusion criteria

  • Patients with prior exposure of G-CSF or GM-CSF or its pegylated products in clinical development less than 6 months prior to randomization.
  • Myelotoxic concomitant treatment such as chloramphenicol, methotrexate, immunomodulating agents, interferons during 10 days before randomization.
  • Received systemic antibiotic treatment within 72 hours of chemotherapy.
  • Chronic use of corticosteroids, prior bone marrow or stem cell transplant.
  • Patients who had an immediate/ concurrent exposure to radiotherapy or surgery (within 4 weeks).
  • Severe medical disease: cardiovascular, hepatic, renal, pulmonary…
  • Known cases of hematological disease (sickle cell anemia, AML…)
  • History of HIV positive, active hepatitis.
  • Pregnant and lactating women or patients planning to become pregnant.
  • Known allergic reactions to study medications.
  • Positive to anti-pegfilgrastim antibody test

Treatment and study plan

pegcyte

Drug

Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.

Other names: pegfilgrastim

Neulastim

Drug

Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.

Other names: pegfilgrastim

Primary outcomes

  1. Percentage of patients who developed Febrile neutropenia in cycle 1,2 and 3

    Time frame: 0 to 42 days)

Secondary outcomes

  1. Incidence of grade 4 severe neutropenia

    Time frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)

  2. Incidence of antibiotics use

    Time frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)

  3. Incidence of adverse events

    Time frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)

  4. Changes in laboratory safety parameters

    Time frame: in cycle 1,2 and 3 (0 to 14 , 28 and 42 days)

    including vital signs

  5. Presence of antibodies against Pegfilgrastim

    Time frame: at the end of cycle 3 (42 day)

Sponsors and collaborators

Lead sponsor

Nanogen Pharmaceutical Biotechnology Joint Stock Company

Industry

Registry information

Official study title

A Randomized, Double-blind, Parallel Study Comparing Efficacy and Safety of Pegcyte (Nanogen) and Reference Product Neulastim (Roche) for Prevention of Chemotherapy (Accelerated AC Regimen)Induced Neutropenia in Breast-cancer Patients.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2017
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.