NCT00261313CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 80
- Primary Endpoint
- The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Breast cancer diagnosis node-positive or high risk node negative
- •Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.
Exclusion Criteria
- •Metastatic breast cancer
- •Clinically significant cardiac disease
Arms & Interventions
Aranesp
Experimental
Intervention: Aranesp (Drug)
Neulasta
Experimental
Intervention: Neulasta (Drug)
Outcomes
Primary Outcomes
The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
Time Frame: 3 months
Secondary Outcomes
- Febrile neutropenic events and adverse event profile will be assessed(4 months)
- To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities(3 months)
- Frequency of red blood cell (RBC) transfusions(3 months)
Investigators
Similar Trials
Unknown
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