Breast CancerPhase 2NCT00146562
Pegfilgrastim and Darbepoetin Alfa in Support of Adjuvant Chemotherapy for Breast Cancer
A Phase 2 study testing Darbepoetin Alfa, Pegfilgrastim and Paclitaxel in people with Breast Cancer and Stage I Breast Cancer, run by Harold J. Burstein, MD, PhD at 6 sites in United States.
Trial summary
The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer
- What is being tested?
- Darbepoetin Alfa, Pegfilgrastim and Paclitaxel
- Type of treatment
- Injection or infusion
- How many people
- 135 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2003to May 2007
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically or cytologically confirmed breast cancer clinical stage I, II or III disease. Patients must be deemed of sufficient risk for tumor or recurrence
- Patients may receive the defined adjuvant chemotherapy treatment either following definitive breast surgery or prior to definitive breast surgery
- 18 years of age or older
- ECOG performance status 0 or 1
- ANC > 1,500/uL
- Hemoglobin > 9 g/dL
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- Platelets > 100,000/ul
- Total bilirubin less than or equal to ULN
- AST/ALT < 1.5 x ULN
- Creatinine within normal institutional limits
- PT/PTT < institutional upper limit of normal
- LVEF > 50%
Who cannot join
- Previous cytotoxic chemotherapy or therapeutic radiation therapy
- Pregnant or lactating women
- Receiving any other investigational agents
- Stage IV breast cancer
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pegfilgrastim or darbepoetin
- Previous exposure to G-CSF or pegfilgrastim or to recombinant erythropoetin-related growth factors.
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- On antibiotics within 72 hours of registration
- Patients with immune deficiency who are at increased risk of lethal infections when treated with marrow-suppressive therapy, or HIV-positive patients receiving anti-retroviral therapy
- Sickle cell disease
- Known positive antibody response to any erythropoietic agent
- Known hematologic diseases
- Known history of hyperviscosity syndrome
- Patients on lithium
- RBC transfusion within past 4 weeks
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Faulkner Hospital
Boston, Massachusetts, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lowell General Hospital
Lowell, Massachusetts, 01854
North Shore Cancer Center
Peabody, Massachusetts, 01960
About this study
Official title: A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer
The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients.
Read the detailed description
- Patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of approximately 16 weeks, total) of treatment. On the day of chemotherapy treatment patients may receive an injection of darbepoetin alfa in addition to chemotherapy if their red blood cell count is below normal levels.
- On the day after chemotherapy treatment, patients will receive an injection of pegfilgrastim. There is one pegfilgrastim shot given per treatment cycle, for a total of 8 injections. Once the patient has finished chemotherapy and the last of the pegfilgrastim shots, their participation in this trial will be complete.
- While on this study the following procedures will be performed: a physical exam will be done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2 weeks.
- This study also involves a Quality of Life Questionnaire done at the beginning of study treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study treatment.
- Patients will remain on this study unless they experience unacceptable side effects from any of the treatment drugs.
- Conditions
- Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer
- Being tested
- Darbepoetin Alfa, Pegfilgrastim, Paclitaxel, Doxorubicin, Cyclophosphamide
- Keywords
- adjuvant chemotherapy, G-CSF, pegfilgrastim, darbepoetin alfa
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin AlfaDrug
Also called Aranesp
Given day before chemotherapy of red blood cell count is below normal
PegfilgrastimDrug
Also called Neulasta
Given as an injection the day before chemotherapy for a total of 8 injections
PaclitaxelDrug
As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
DoxorubicinDrug
As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
CyclophosphamideDrug
As part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.
Measured: 2 years
Secondary outcomes (1)
To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionMay 2007
- Study completionMay 2007
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harold J. Burstein, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Lowell General Hospital, Brigham and Women's Hospital, North Shore Medical Center
- Responsible party
- Sponsor-investigator, Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- Harold Burstein, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146562
- Sponsor's protocol ID
- 03-154
- Status last verified
- May 2023
- First submitted
- 2 Sep 2005
- Last updated
- 2 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pegfilgrastim (Neulasta) and Darbepoetin Alfa (Aranesp) in Support of Dose-Dense Adjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT00146562
- Acronym / sponsor ID
- 03-154
- Conditions
- Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer
- Keywords
- adjuvant chemotherapy, G-CSF, pegfilgrastim, darbepoetin alfa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Harold J. Burstein, MD, PhDUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Lowell General Hospital, Brigham and Women's Hospital, North Shore Medical Center
- Study start
- Jul 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 7 Sep 2005 (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.
The main purpose of this study is to see if pegfilgrastim (Neulasta) is safe and useful in supporting people through dose-dense chemotherapy, and to see if a long-acting red blood cell growth factor, darbepoetin alfa(Aranesp) can reduce the need for blood transfusion in chemotherapy recipients.
Detailed description
- Patients will receive chemotherapy every 2 weeks for up to 8 cycles (spread out of approximately 16 weeks, total) of treatment. On the day of chemotherapy treatment patients may receive an injection of darbepoetin alfa in addition to chemotherapy if their red blood cell count is below normal levels.
- On the day after chemotherapy treatment, patients will receive an injection of pegfilgrastim. There is one pegfilgrastim shot given per treatment cycle, for a total of 8 injections. Once the patient has finished chemotherapy and the last of the pegfilgrastim shots, their participation in this trial will be complete.
- While on this study the following procedures will be performed: a physical exam will be done every 2 weeks, vital signs will be done every 2 weeks, and blood tests every 2 weeks.
- This study also involves a Quality of Life Questionnaire done at the beginning of study treatment, at 2 months, 4 months, 6 months, and 1 year after starting the study treatment.
- Patients will remain on this study unless they experience unacceptable side effects from any of the treatment drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed breast cancer clinical stage I, II or III disease. Patients must be deemed of sufficient risk for tumor or recurrence
- Patients may receive the defined adjuvant chemotherapy treatment either following definitive breast surgery or prior to definitive breast surgery
- 18 years of age or older
- ECOG performance status 0 or 1
- ANC > 1,500/uL
Key exclusion criteria (14 listed)
- Previous cytotoxic chemotherapy or therapeutic radiation therapy
- Pregnant or lactating women
- Receiving any other investigational agents
- Stage IV breast cancer
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pegfilgrastim or darbepoetin
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 |
|---|---|---|
| Darbepoetin AlfaAlso: AranespGiven day before chemotherapy of red blood cell count is below normal | Drug | – |
| PegfilgrastimAlso: NeulastaGiven as an injection the day before chemotherapy for a total of 8 injections | Drug | – |
| PaclitaxelAs part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles | Drug | – |
| DoxorubicinAs part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles | Drug | – |
| CyclophosphamideAs part of standard adjuvant chemotherapy: Given every two weeks for 8 cycles | Drug | – |
Primary outcome
To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.
Time frame: 2 years
1 secondary outcome
To determine the rate of RBC transfusion among patients treated with dose-dense adjuvant chemotherapy receiving darbepoetin every 2 weeks.
Time frame: 2 years
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 2 Aug 2023.
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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.
Harold Burstein, MD, PhD principal investigator
Dana-Farber Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darbepoetin Alfa, Pegfilgrastim and Paclitaxel in people with Breast Cancer and Stage I Breast Cancer, run by Harold J. Burstein, MD, PhD at 6 sites in United States.
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 12 inclusion and 14 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks. (time frame: 2 years). 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 2 Aug 2023.