Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

NCT02527317 | Completed

• 1 other identifier: B1010
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-interventional, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast cancer.

Conditions

Breast Cancer

Keywords

Early

Outcome Measures

Primary Outcomes (1)

• incidence of treatment-related neutropenia

  The primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).

  four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).

Secondary Outcomes (2)

• incidence of febrile neutropenia

  four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).

• incidence of treatment-related neutropenia

  Up to 1 year of subsequent chemotherapy

Interventions

Lipegfilgrastim DRUG

Investigate the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).

Also known as: Lonquex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) for early breast cancer

You may qualify if:

• Age ≥ 18 years
• Stage I-III Breast Cancer
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1(see below)
• Adequate Bone Marrow Function as defined by neutrophil count of ≥1.0 and platelet count of ≥ 100
• Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) as deemed appropriate by a Consultant Medical Oncologist
• General Indications for Dose Dense AC include:
• T3 or T4 Tumours
• N1 - N3 (Node Positive) Disease
• Human Epidermal Growth Factor Receptor 2 (HER2) Positive Tumours.
• Triple Negative Breast Cancer as evidenced by lack of expression of the estrogen receptor (ER), progesterone receptor (PR) and HER2

You may not qualify if:

• Stage IV Breast Cancer
• Pregnancy
• Previous Chemotherapy Exposure
• Prior Exposure to G-CSF
• Known positive HIV Status
• Cardiac or other concurrent illness, which at the investigator's discretion contraindicates the use of AC

Sponsors & Collaborators

• Beaumont Hospital: lead

Study Sites (1)

Beaumont Hospital

Dublin, DUBLIN 9, Ireland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patrick G Patrick, MD

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Medical Oncologist

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: August 19, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

IE (1)