Clinical cooperative trials of the National Cancer Institute of Canada Clinical Trials Group Breast Cancer Site Group. 1994

K I Pritchard
Toronto-Bayview Regional Cancer Centre, Ontario, Canada.

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.

UI MeSH Term Description Entries
D001943 Breast Neoplasms Tumors or cancer of the human BREAST. Breast Cancer,Breast Tumors,Cancer of Breast,Breast Carcinoma,Cancer of the Breast,Human Mammary Carcinoma,Malignant Neoplasm of Breast,Malignant Tumor of Breast,Mammary Cancer,Mammary Carcinoma, Human,Mammary Neoplasm, Human,Mammary Neoplasms, Human,Neoplasms, Breast,Tumors, Breast,Breast Carcinomas,Breast Malignant Neoplasm,Breast Malignant Neoplasms,Breast Malignant Tumor,Breast Malignant Tumors,Breast Neoplasm,Breast Tumor,Cancer, Breast,Cancer, Mammary,Cancers, Mammary,Carcinoma, Breast,Carcinoma, Human Mammary,Carcinomas, Breast,Carcinomas, Human Mammary,Human Mammary Carcinomas,Human Mammary Neoplasm,Human Mammary Neoplasms,Mammary Cancers,Mammary Carcinomas, Human,Neoplasm, Breast,Neoplasm, Human Mammary,Neoplasms, Human Mammary,Tumor, Breast
D002170 Canada The largest country in North America, comprising 10 provinces and three territories. Its capital is Ottawa.
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003131 Combined Modality Therapy The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used. Multimodal Treatment,Therapy, Combined Modality,Combined Modality Therapies,Modality Therapies, Combined,Modality Therapy, Combined,Multimodal Treatments,Therapies, Combined Modality,Treatment, Multimodal,Treatments, Multimodal
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000971 Antineoplastic Combined Chemotherapy Protocols The use of two or more chemicals simultaneously or sequentially in the drug therapy of neoplasms. The drugs need not be in the same dosage form. Anticancer Drug Combinations,Antineoplastic Agents, Combined,Antineoplastic Chemotherapy Protocols,Antineoplastic Drug Combinations,Cancer Chemotherapy Protocols,Chemotherapy Protocols, Antineoplastic,Drug Combinations, Antineoplastic,Antineoplastic Combined Chemotherapy Regimens,Combined Antineoplastic Agents,Agent, Combined Antineoplastic,Agents, Combined Antineoplastic,Anticancer Drug Combination,Antineoplastic Agent, Combined,Antineoplastic Chemotherapy Protocol,Antineoplastic Drug Combination,Cancer Chemotherapy Protocol,Chemotherapy Protocol, Antineoplastic,Chemotherapy Protocol, Cancer,Chemotherapy Protocols, Cancer,Combinations, Antineoplastic Drug,Combined Antineoplastic Agent,Drug Combination, Anticancer,Drug Combination, Antineoplastic,Drug Combinations, Anticancer,Protocol, Antineoplastic Chemotherapy,Protocol, Cancer Chemotherapy,Protocols, Antineoplastic Chemotherapy,Protocols, Cancer Chemotherapy
D017024 Chemotherapy, Adjuvant Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment. Adjuvant Chemotherapy,Drug Therapy, Adjuvant,Adjuvant Drug Therapy
D017322 Clinical Trials, Phase II as Topic Works about studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries. Drug Evaluation, FDA Phase 2 as Topic,Drug Evaluation, FDA Phase II as Topic,Evaluation Studies, FDA Phase 2 as Topic,Evaluation Studies, FDA Phase II as Topic

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