Breast CancerNCT02527317
Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer
An observational study of Breast Cancer, run by Beaumont Hospital at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lipegfilgrastim
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- Jan 2015to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) for early breast cancer
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support
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.
Read the detailed description
An important advance in the use of dose dense chemotherapy regimens for breast cancer was the development of pegylated form of G-CSF (pegfilgrastim and lipegfilgrastim), which offered the convenience of single subcutaneous injection, rather than multiple daily injections
Lipegfilgrastim is a pegylated long-acting covalent conjugate of filgrastim (G-CSF). In a pivotal randomized phase III study in breast cancer lipegfilgrastim was shown to be non-inferior to pegfilgrastim.
In this prospective observational study the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support is being investigated.
Data will be collected on 40 consecutive patients treated with AC and lipegfilgrastim in Ireland.
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).
Secondary Objectives
- Determine the incidence of febrile neutropenia during 4 cycles (8 weeks)of dose dense AC with lipegfilgrastim
- Examine the incidence of treatment-related neutropenia during subsequent intravenous cancer therapy up to 1 year.
- Conditions
- Breast Cancer
- Being tested
- Lipegfilgrastim
- Keywords
- Early
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipegfilgrastimDrug
Also called Lonquex
Investigate the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
Secondary outcomes (2)
incidence of febrile neutropenia
Determine the incidence of febrile neutropenia during 4 cycles (8 weeks) of dose dense AC with lipegfilgrastim
Measured: four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
incidence of treatment-related neutropenia
Determine the incidence of treatment-related neutropenia during subsequent chemotherapy (up to 1 year)
Measured: Up to 1 year of subsequent chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Morris, Beaumont Hospital
- Investigators
- Patrick G Patrick, MD, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527317
- Sponsor's protocol ID
- B1010
- Status last verified
- Feb 2018
- First submitted
- 3 Jun 2015
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Dose Dense Chemotherapy With Lipegfilgrastim Support
- ClinicalTrials.gov ID
- NCT02527317
- Acronym / sponsor ID
- B1010
- Conditions
- Breast Cancer
- Keywords
- Early
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An important advance in the use of dose dense chemotherapy regimens for breast cancer was the development of pegylated form of G-CSF (pegfilgrastim and lipegfilgrastim), which offered the convenience of single subcutaneous injection, rather than multiple daily injections
Lipegfilgrastim is a pegylated long-acting covalent conjugate of filgrastim (G-CSF). In a pivotal randomized phase III study in breast cancer lipegfilgrastim was shown to be non-inferior to pegfilgrastim.
In this prospective observational study the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support is being investigated.
Data will be collected on 40 consecutive patients treated with AC and lipegfilgrastim in Ireland.
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).
Secondary Objectives
- Determine the incidence of febrile neutropenia during 4 cycles (8 weeks)of dose dense AC with lipegfilgrastim
- Examine the incidence of treatment-related neutropenia during subsequent intravenous cancer therapy up to 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) for early breast cancer
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- Stage IV Breast Cancer
- Pregnancy
- Previous Chemotherapy Exposure
- Prior Exposure to G-CSF
- Known positive HIV Status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipegfilgrastimAlso: LonquexInvestigate the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks). | Drug | – |
Primary outcome
incidence of treatment-related neutropenia
Time frame: four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
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).
2 secondary outcomes
incidence of febrile neutropenia
Time frame: four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
incidence of treatment-related neutropenia
Time frame: Up to 1 year of subsequent chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick G Patrick, MD principal investigator
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Beaumont Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of treatment-related neutropenia (time frame: four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.