Phase II study of the addition of darbepoetin alfa (Aranesp) and pegfilgrastim (Neulasta) support for optimal dose-dense chemotherapy for early breast cancer

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000731695

Enrollment

Registered

2005-11-11

Start date

2006-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

To optimise planned & received dose intensity (RDI) in a dose-dense chemotherapy regimen consisting of doxorubicin and cyclophosphamide followed by paclitaxel, gemcitabine (AC->PG) by adding pegfilgrastim (NeulastaÂ®) and darbepoetin alfa (AranespÂ®) for the treatment of patients with early stage breast cancer.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast.No prior treatment other than surgery is permitted.

Exclusion criteria

No exclusion criteria

Outcome results