None listed
Conditions
Brief summary
This is a dose dense breast cancer study in teh adjuvant setting using growth factor support
Interventions
Dose dense doxorubicin and cyclophosphamide followed by paclitaxel will be given to patients every 14 days for a total of 8 cycles. Each cycle will be suported with pegfilgrastim and for patients who have HB <110 g/ml, darbepotin alfa will be administered.
Sponsors
Amgen Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Lymph node positive (AJCC stage IIA, IIB or IIIA (T0-3, N1-2, M0) OR 2) High risk lymph node negative, defined as any/all of the following: Hormone receptor negative, <35 years old, T2-3, Histological grade III-Primary surgery consisting of removal of the entire cancer-ECOG 0, 1 or 2-Normal marrow and organ function.
Exclusion criteria
Stage IIIB, IIIC or IV breast cancer- Documented HER2 neu postive disease- Prior malignancy within 5 years except curatively treated basal cell carcinoma, in-situ cervical catrcinoma or a surgically cured malignancy- Previous cytotoxic chemotherapy or therapeutic radiation.
Outcome results
None listed