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”

Woman Man

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Extract

The overall aim of the CASA trial is to investigate the role of PLD as adjuvant chemotherapy for older postmenopausal women (66 years old and above). The stratified analysis combining the results of both randomization options will provide the primary evidence on the effectiveness of PLD. This analysis will assess PLD versus non-PLD-containing control groups (either nil or CM). In addition, analyses will be conducted separately for each of the two randomization options (adjusted for multiple comparisons) to assess each of the individual pair-wise contributions to the overall result.

Inclusion criteria

Older women (66 years of age or older) with histologically proven, resected breast cancer. The disease must be classified as endocrine nonresponsive and patients must not be candidates for endocrine therapy or for an adjuvant chemotherapy program which includes a “standard” anthracycline-containing chemotherapy regimen

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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...