A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy

An observational study of Breast Cancer and Non-Small Cell Lung Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer
How many people: 1,370 participants
Where: No sites listed yet
Study dates: Nov 2006to Sep 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Sites were selected based on where medical data of interest were routinely and completely collected. To avoid geographical bias, sites represented various types of treating centers within each country and sites were encouraged to provide data on patients within all tumor types.

Who may be able to join

Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.
These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines

Who cannot join

Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).

About this study

Official title: A Prospective Observational Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy

Read the detailed description

This is a multi-center international observational study of patients receiving myelotoxic regimens, with an investigator assessed risk of febrile neutropenia ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung).

This is an observational study in which patient risk factors were qualitatively (but not quantitatively) assessed, and adherence to G-CSF primary prophylaxis was at the discretion of physicians and not mandated by the protocol.

Conditions: Breast Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Small Cell Lung Cancer
Medical subject headings: Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Small Cell Lung Carcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Febrile Neutropenia (FN)
Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm².
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.
Measured: Cycles 1 - 8 (approximately 24 weeks)

Secondary outcomes (34)

Number of Participants Who Received G-CSF During Cycles 1 to 8
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim
The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF
The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim
The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF
The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim
The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8
A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.
Measured: Cycles 2 - 8 (approximately 21 weeks)
Percentage of Cycles With Chemotherapy Dose Delays
A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.
Measured: Cycles 2 - 8 (approximately 21 days)
Percentage of Participants With Chemotherapy Dose Reductions
A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Cycles With Chemotherapy Dose Reductions
A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8
A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle.
Measured: Cycles 2 - 8 (approximately 21 weeks)
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8
A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8
Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Participants With Unplanned Hospitalizations
Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Investigator Assessed Clinical Response at End of Treatment
Measured: End of treatment (approximately 24 weeks)
Number of Participants With Hematological Toxicities
The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: < 1.0 - 0.5 x 10^9/L; ANC - Grade 4: < 0.5 x 10^9/L; White blood cells (WBC) - Grade 3: < 2.0 - 1.0 x 10^9/L; WBC - Grade 4: < 1.0 x 10^9/L; Hemoglobin - Grade 3: < 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: < 6.5 g/dL; Platelets - Grade 3: < 50 - 25 x 10^9/L; Platelets - Grade 4: < 25 x 10^9/L.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Time to Disease Progression
Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.
Measured: From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.
Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)
Measured: Cycles 1 - 8 (approximately 24 weeks)
Reason for Treatment With Erythropoiesis-stimulating Agents
The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Clinical Visits in Cycles 1-8 by ESA Use
The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment
Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Measured: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Change in Hemoglobin During ESA Treatment Phase
Measured: Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response
Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Measured: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Measured: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Measured: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Measured: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Measured: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment
Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.
Measured: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment
The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment.
Measured: 9 weeks post initiation of ESA treatment
Number of Participants With Systemic Transfusions in Cycles 1 to 8
Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8.
Measured: Cycles 1 - 8 (approximately 24 weeks)
Number of Transfusions Per Participant in Cycles 1 to 8
Measured: Cycles 1 - 8 (approximately 24 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Sep 2014

First posted17 Apr 2009 (estimated)
Study startNov 2006
Primary completionOct 2009
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
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: Other
Time perspective: Prospective
Enrolment: 1,370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00883181
Sponsor's protocol ID: 20060445
Status last verified: Feb 2017
First submitted: 16 Apr 2009
Last updated: 15 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Maenpaa J, Varthalitis I, Erdkamp F, Trojan A, Krzemieniecki K, Lindman H, Bendall K, Vogl FD, Verma S. The use of granulocyte colony stimulating factor (G-CSF) and management of chemotherapy delivery during adjuvant treatment for early-stage breast cancer--further observations from the IMPACT solid study. Breast. 2016 Feb;25:27-33. doi: 10.1016/j.breast.2015.11.007. Epub 2015 Dec 20.
PubMed 26801413

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Observational Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy
ClinicalTrials.gov ID: NCT00883181
Acronym / sponsor ID: 20060445
Conditions: Breast Cancer, Non-Small Cell Lung Cancer, Ovarian Cancer, Small Cell Lung Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 1,370 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Oct 2009 (actual)
Study completion: Sep 2014 (actual)
First posted: 17 Apr 2009 (estimated)
Results: Posted 8 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Sites were selected based on where medical data of interest were routinely and completely collected. To avoid geographical bias, sites represented various types of treating centers within each country and sites were encouraged to provide data on patients within all tumor types.

Key inclusion criteria (2 listed)

Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.
These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines

Key exclusion criteria (1 listed)

Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants With Febrile Neutropenia (FN)
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm².
Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.
Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.
Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.
Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.
Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.
Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia
Time frame: Cycles 1 - 8 (approximately 24 weeks)
FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

34 secondary outcomes

Number of Participants Who Received G-CSF During Cycles 1 to 8
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8
Time frame: Cycles 2 - 8 (approximately 21 weeks)
Percentage of Cycles With Chemotherapy Dose Delays
Time frame: Cycles 2 - 8 (approximately 21 days)
Percentage of Participants With Chemotherapy Dose Reductions
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Cycles With Chemotherapy Dose Reductions
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8
Time frame: Cycles 2 - 8 (approximately 21 weeks)
Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Participants With Unplanned Hospitalizations
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Investigator Assessed Clinical Response at End of Treatment
Time frame: End of treatment (approximately 24 weeks)
Number of Participants With Hematological Toxicities
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Time to Disease Progression
Time frame: From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months.
Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs)
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Reason for Treatment With Erythropoiesis-stimulating Agents
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Clinical Visits in Cycles 1-8 by ESA Use
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Change in Hemoglobin During ESA Treatment Phase
Time frame: Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment
Time frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks.
Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment
Time frame: 9 weeks post initiation of ESA treatment
Number of Participants With Systemic Transfusions in Cycles 1 to 8
Time frame: Cycles 1 - 8 (approximately 24 weeks)
Number of Transfusions Per Participant in Cycles 1 to 8
Time frame: Cycles 1 - 8 (approximately 24 weeks)

Results and safety

Results posted to the registry on 8 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full Analysis Set	1,347	1,069

Primary outcome: Percentage of Participants With Febrile Neutropenia (FN)

Time frame: Cycles 1 - 8 (approximately 24 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Ovarian n = 157	NSCLC n = 224	SCLC n = 137	Breast Stage I-III n = 738	Breast Metastatic n = 90	Breast Total n = 829
Value	8 (4 to 13)	8 (5 to 12)	15 (10 to 21)	9 (7 to 11)	11 (6 to 19)	9 (7 to 11)

Population analysed: Full analysis set; Note: One participant with breast cancer had disease stage missing.

Primary outcome: Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia

Time frame: Cycles 1 - 8 (approximately 24 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Ovarian n = 82	NSCLC n = 120	SCLC n = 56	Breast Stage I-III n = 147	Breast Metastatic n = 28	Breast Total n = 175
Value	4 (1 to 10)	3 (1 to 7)	5 (2 to 15)	1 (1 to 4)	0 (NA to NA)	1 (1 to 3)

Population analysed: Full analysis set participants who received no prophylaxis or treatment with any G-CSF

Primary outcome: Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia

Time frame: Cycles 1 - 8 (approximately 24 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Ovarian n = 24	NSCLC n = 22	SCLC n = 33	Breast Stage I-III n = 360	Breast Metastatic n = 32	Breast Total n = 393
Value	0 (NA to NA)	0 (NA to NA)	21 (11 to 38)	9 (7 to 13)	9 (3 to 24)	9 (7 to 13)

Population analysed: Full analysis set participants who received primary prophylaxis with pegfilgrastim

Primary outcome: Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia

Time frame: Cycles 1 - 8 (approximately 24 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Ovarian n = 6	NSCLC n = 20	SCLC n = 11	Breast Stage I-III n = 51	Breast Metastatic n = 6	Breast Total n = 57
Value	0 (NA to NA)	20 (8 to 42)	9 (2 to 38)	6 (2 to 16)	17 (3 to 56)	7 (3 to 17)

Population analysed: Full analysis set participants who received primary prophylaxis with any daily G-CSF

34 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 24 weeks (8 treatment cycles). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ovarian	0 of 157 (0%)	1 of 157 (0.6%)	Not reported
NSCLC	1 of 224 (0.4%)	0 of 224 (0%)	Not reported
SCLC	0 of 137 (0%)	1 of 137 (0.7%)	Not reported
Breast Stage I-III	1 of 738 (0.1%)	37 of 738 (5%)	Not reported
Breast Metastatic	0 of 90 (0%)	1 of 90 (1.1%)	Not reported
Breast Total	1 of 829 (0.1%)	38 of 829 (4.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26801413Maenpaa J, Varthalitis I, Erdkamp F, Trojan A, Krzemieniecki K, Lindman H, Bendall K, Vogl FD, Verma S. The use of granulocyte colony stimulating factor (G-CSF) and management of chemotherapy delivery during adjuvant treatment for early-stage breast cancer--further observations from the IMPACT solid study. Breast. 2016 Feb;25:27-33. doi: 10.1016/j.breast.2015.11.007. Epub 2015 Dec 20.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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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.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Non-Small Cell Lung Cancer, run by Amgen.

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 2 inclusion and 1 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 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 8 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Febrile Neutropenia (FN) (time frame: Cycles 1 - 8 (approximately 24 weeks)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00883181, which also lists 1 linked publication.

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 15 Mar 2017.