Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx, Doxil) for Women (Age 66 Years or Older) With Endocrine Nonresponsive Breast Cancer Who Are Not Suitable for Being Offered a " Standard Chemotherapy Regimen"
- Compare the breast cancer-free interval in elderly women with resectable, hormone
receptor-negative breast cancer treated with pegylated doxorubicin hydrochloride
liposome (PDL) vs observation or PDL vs cyclophosphamide and methotrexate.
- Compare the tolerability of these regimens in these patients.
- Compare the safety and toxic effects of these regimens in these patients.
- Compare the overall and progression-free survival of patients treated with these
- Compare the quality of life of patients treated with these regimens.
- Compare the sites of failure in patients treated with these regimens.
- Compare the competing causes of death in patients treated with these regimens.
- Compare the rate of second non-breast malignancy in patients treated with these
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are assigned, based on patient preference, to 1 of 2
- Group 1: Patients are randomized to 1 of 2 arms (arms I and II).
- Arm I: Patients receive pegylated doxorubicin hydrochloride liposome (PDL) IV over
1 hour on day 1. Treatment repeats every 2 weeks for 8 courses in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients undergo observation only.
- Group 2: Patients are randomized to 1 of 2 treatment arms (arms III and IV).
- Arm III: Patients receive PDL as in arm I.
- Arm IV: Patients receive oral cyclophosphamide once daily on days 1-7 and oral
methotrexate twice daily on days 1 and 4. Treatment repeats every week for 16
courses in the absence of disease progression or unacceptable toxicity.
All patients may undergo radiotherapy according to institutional standards either during
surgery or after the completion of chemotherapy.
Quality of life is assessed at baseline and at 3, 6, and 12 months.
After completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 1,296 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Breast cancer free interval by physical examination, laboratory tests, and investigations every 2 weeks for 16 weeks during treatment, every 3-6 months for 5 years, then annually as indicated after completion of study treatment
5 years after recruitment starts
Diana Crivellari, MD
Centro di Riferimento Oncologico, Aviano (Italy)
Australia: Department of Health and Ageing Therapeutic Goods Administration