Breast CancerPhase 2NCT00261313
ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer
A Phase 2 study testing Neulasta and Aranesp in people with Breast Cancer, run by Amgen.
Trial summary
This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neulasta and Aranesp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Dec 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer diagnosis node-positive or high risk node negative
- Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.
Who cannot join
- Metastatic breast cancer
- Clinically significant cardiac disease
About this study
Official title: An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer
This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.
- Conditions
- Breast Cancer
- Being tested
- Neulasta, Aranesp
- Keywords
- Breast cancer, Doses dense chemotherapy, Growth factor support, Adjuvant Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeulastaDrug
6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy
AranespDrug
If Hb drops below 110, 300mcg Aranesp will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Aranesp | Experimental | Not described Receives: Drug: Aranesp |
| Neulasta | Experimental | Not described Receives: Drug: Neulasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
Measured: 3 months
Secondary outcomes (3)
Febrile neutropenic events and adverse event profile will be assessed
Measured: 4 months
To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities
Measured: 3 months
Frequency of red blood cell (RBC) transfusions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJun 2007
- Study completionDec 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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261313
- Sponsor's protocol ID
- 20040137
- Status last verified
- Feb 2010
- First submitted
- 2 Dec 2005
- Last updated
- 26 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00261313
- Acronym / sponsor ID
- 20040137
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Doses dense chemotherapy, Growth factor support, Adjuvant Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 5 Dec 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.
This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aranesp | Experimental | Drug: Aranesp |
| Neulasta | Experimental | Drug: Neulasta |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast cancer diagnosis node-positive or high risk node negative
- Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.
Key exclusion criteria (2 listed)
- Metastatic breast cancer
- Clinically significant cardiac disease
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 |
|---|---|---|
| Neulasta6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy | Drug | Neulasta |
| AranespIf Hb drops below 110, 300mcg Aranesp will be administered. | Drug | Aranesp |
Primary outcome
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
Time frame: 3 months
3 secondary outcomes
Febrile neutropenic events and adverse event profile will be assessed
Time frame: 4 months
To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities
Time frame: 3 months
Frequency of red blood cell (RBC) transfusions
Time frame: 3 months
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 26 Feb 2010.
- 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?
A Phase 2 study testing Neulasta and Aranesp in people with Breast 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 2 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 26 Feb 2010. 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.
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?
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study (time frame: 3 months). 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 26 Feb 2010.