THE ANZ0001 CLINICAL TRIAL

Tailoring Treatments and Providing More Options for Patients

Chemotherapy treatment can improve the length and quality of life for women with advanced breast cancer. However, not all women can tolerate intensive chemotherapy regimens.

This may be due to age; the presence of other diseases or medical conditions; or if the cancer is indolent and/or is predominantly location in the bone. Some women may also want to limit treatment toxicity and prefer less intensive chemotherapy, such as patients whose cancer has relapsed after previous intensive chemotherapy treatment.

The ANZ0001 trial examined a less intensive chemotherapy treatment for women with advanced breast cancer, and measured the effect on disease and treatment on both length and quality of life. Patients were offered twice daily oral chemotherapy treatment (capecitabine) to see if it was more effective than the standard chemotherapy available at the time for that patient population.

A secondary objective of the study was to determine the ideal administration of the capecitabine treatment and whether continuous twice daily administration was better for these patients than the same dose administered intermittently for two weeks out of every three.

The study found that both schedules of capecitabine treatment improved overall survival and quality of life of patients, while being similarly active, less toxic and better tolerated than standard treatment, for women with advanced breast cancer who are not suited to intensive chemotherapy.

This important research provided a new treatment option for these patients, that is suitable to their individual circumstances whilst maintaining good outcomes. The results are still relevant and remain commonly used in routine clinical practice today, more than 20 years after the trial commenced.

ANZ001 was led and coordinated by Breast Cancer Trials (BCT) and 324 women participated in the study at 34 institutions across Australia and New Zealand. The BCT Study Chair was Professor Martin Stockler.

The results of the trial were presented at the San Antonio Breast Cancer Symposium, the European Breast Cancer Conference and the Australasian Society for Breast Disease conference. They were published in the Journal of Clinical Oncology, Breast Cancer Research and Treatment, British Journal of Cancer, and European Journal of Cancer.