Older women with hormone receptor negative early breast cancer who may currently be missing out on effective post-operative anticancer drugs will be able to participate in a new clinical trial specifically aimed at this group of women.
Nearly 1300 women aged 66 years and over with the type of early breast cancer that does not respond to hormone treatments, such as tamoxifen, will be recruited to the Chemotherapy Adjuvant Studies for Women at Advanced Age (CASA) trial. It will be coordinated by the International Breast Cancer Study Group (IBCSG), with worldwide participation by the Breast International Group (BIG) and support from Schering-Plough Corporation.
The study, announced this week at the 9th International Conference -- Primary Therapy of Early Breast Cancer, will investigate the effectiveness of a novel form of chemotherapy, called pegylated liposomal doxorubicin (Caelyx, Schering-Plough Corporation), on breast cancer recurrence and survival after surgery. It will also compare Caelyx with another, low-dose combination of anticancer drugs.
Dr. Silvia Dellapasqua, from the IBCSG in Bern, Switzerland, who is one of the study chairs of the CASA trial, explains that doctors currently face a dilemma about how to treat the 15-30% of older women with early breast cancer that does not respond to hormone treatment.
"Some physicians may decide not to offer any further therapy after appropriate surgery, especially if the woman is unfit for treatment," said Dr. Dellapasqua. "Others may modify chemotherapy schedules that are used in younger women attempting empirically to avoid subjective toxic effects, which are more common and less tolerable in older patients. We hope that the CASA study will help to establish new standards of care for these older women."
The CASA study (IBCSG 32-05 / BIG 1-05) will be conducted with 1296 patients aged 66 years or older with early breast cancer classified as nonresponsive to hormonal treatments. The duration of adjuvant treatment programs in the trial will be 16 weeks.