Adjuvant Cytotoxic Chemotherapy In Older Women
- To provide evidence for extending the current standard care in older women with
invasive breast carcinoma treated with adjuvant chemotherapy comprising doxorubicin
hydrochloride or epirubicin hydrochloride and cyclophosphamide.
- Compare the relapse-free survival interval of these patients treated with adjuvant
chemotherapy vs no adjuvant chemotherapy.
- Compare the toxicity of accelerated adjuvant chemotherapy with pegfilgrastim support vs
non-accelerated adjuvant chemotherapy.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center and indication for endocrine therapy (yes vs no). Patients are randomized to 1 of 2
- Arm I (observation): Patients do not receive adjuvant chemotherapy.
- Arm II (adjuvant chemotherapy): Patients are randomized to 1 of 2 chemotherapy
- Accelerated adjuvant chemotherapy: Patients receive doxorubicin hydrochloride and
cyclophosphamide (AC) OR epirubicin hydrochloride and cyclophosphamide (EC) on day
1 and pegfilgrastim on day 2. Treatment repeats every 2 weeks for 4 courses in the
absence of disease progression or unacceptable toxicity.
- Non-accelerated adjuvant chemotherapy: Patients receive AC or EC on day 1.
Treatment repeats every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection for biological, pharmacological,
and proteomic studies. Samples are initially used to establish a resource of materials
available for different research groups. Samples are also analyzed using SELDI or MALDI-ToF
technology to identify biological profiles that correlate with prognosis or predict response
Quality of life is assessed at baseline, 6 weeks, 1 month, 6 months, 9 months, 12 months, 18
months, and 24 months.
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually thereafter.
Allocation: Randomized, Primary Purpose: Treatment
Robert C.F. Leonard, MD, BS, MB
Charing Cross Hospital