For more than 10 years, the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
Breast Cancer Site Group has focused primarily on trials of adjuvant
therapy and of
investigational new drugs (IND). Four trials of adjuvant
therapy in node-positive women have been completed, are active, or are about to begin.
Investigational new drug (IND) studies have included Phase II trials of intravenous and oral menagaril,
10-EDAM (
edatrexate),
taxotere, and
mifepristone (RU-486) as well as a Phase I/II trial of
5-fluorouracil (5-FU),
doxorubicin, and
vinorelbine (FAN); a Phase I/II trial of
5-FU,
leucovorin,
doxorubicin, and
vinorelbine (super-FAN), all as first-line
therapy for metastatic disease; and a Phase III study of
vinorelbine plus
doxorubicin versus
doxorubicin alone as first- or second-line metastatic
therapy. A proposed study with the European Organization for Research and Treatment of
Cancer in locally advanced
breast cancer will compare a standard NCIC CTG regimen of
cyclophosphamide,
epirubicin, and
5-FU (CEF) with
epirubicin and
cyclophosphamide granulocyte colony-stimulating factor (
G-CSF), a more dose-intensive regimen. In addition, NCIC CTG is preparing a pilot of CEF with
G-CSF to examine whether a substantially more intensive dosage can be given without added toxicity. NCIC CTG will also enter patients into a currently active
Cancer and
Leukemia Group B/Southwest Oncology Group randomized trial of intensive
therapy versus more intensive
therapy with bone marrow support in women younger than age 60 with 10 or more positive nodes. It is believed that optimizing the combination and timing of adjuvant hormonal and
chemotherapy, exploring dose intensive approaches, developing
investigational new drugs, studying the role of biologics, and
tumor banking in conjunction with clinical trials remain important approaches for the future.