An open label phase 2 study of doxorubicin and cyclophosphamide followed by paclitaxel (AC-T) delivered every 14 days with pegfilgrastim and darbepoetin alfa support for the adjuvant treatment of women with breast cancer
Phase 2
Recruiting
- Conditions
- Early stage breast cancerCancer - Breast
- Registration Number
- ACTRN12606000030572
- Lead Sponsor
- Amgen Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects experiencing a delay in any cycle of chemotherapy at any time over the course of the study.[]
- Secondary Outcome Measures
Name Time Method Proportion of chemotherapy cycles dose delayed at any time over the course of study.[];Proportion of subjects experencing any dose reduction at any time over the course of the study.[];Proportion of chemotherapy cycles dose reduced at any time over the course of study.[];Proportion of chemotherapy cycles dose delayed due to haematological toxicity at any time over the course of study.[];Incidence of febrile neutropenia at any time during the study.[];Incidence, units and reasons for RBC transfusion at any time during the study.[];Incidence of adverse events at any time over the course of the study.[]