Spots Global Cancer Trial Database for Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer
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Trial Identification
Brief Title: Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Official Title: 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"
Study ID: NCT00296010
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, and liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer. PURPOSE: This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer.
Detailed Description: OBJECTIVES: Primary * Compare the breast cancer-free interval in elderly women with resectable, hormone receptor-negative breast cancer treated with pegylated doxorubicin hydrochloride liposome (PDL) vs observation or PDL vs cyclophosphamide and methotrexate. Secondary * Compare the tolerability of these regimens in these patients. * Compare the safety and toxic effects of these regimens in these patients. * Compare the overall and progression-free survival of patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. * Compare the sites of failure in patients treated with these regimens. * Compare the competing causes of death in patients treated with these regimens. * Compare the rate of second non-breast malignancy in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are assigned, based on patient preference, to 1 of 2 treatment groups. * Group 1: Patients are randomized to 1 of 2 arms (arms I and II). * Arm I: Patients receive pegylated doxorubicin hydrochloride liposome (PDL) IV over 1 hour on day 1. Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation only. * Group 2: Patients are randomized to 1 of 2 treatment arms (arms III and IV). * Arm III: Patients receive PDL as in arm I. * Arm IV: Patients receive oral cyclophosphamide once daily on days 1-7 and oral methotrexate twice daily on days 1 and 4. Treatment repeats every week for 16 courses in the absence of disease progression or unacceptable toxicity. All patients may undergo radiotherapy according to institutional standards either during surgery or after the completion of chemotherapy. Quality of life is assessed at baseline and at 3, 6, and 12 months. After completion of study treatment, patients are followed periodically for 1 year. PROJECTED ACCRUAL: A total of 1,296 patients will be accrued for this study.
Eligibility
Minimum Age: 66 Years
Eligible Ages: OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Gosford Hospital, Gosford, New South Wales, Australia
Nepean Cancer Care Centre at Nepean Hospital, Kingswood, New South Wales, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Frankston Hospital, Frankston, Victoria, Australia
Institut Jules Bordet, Brussels, , Belgium
Centre Hospitalier Etterbeek Ixelles, Brussels, , Belgium
AZ Groeninge - Oncologisch Centrum, Kortrijk, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman, Liege, , Belgium
National Institute of Oncology, Budapest, , Hungary
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Ospedali Riuniti di Bergamo, Bergamo, , Italy
Ospedale degli Infermi - ASL 12, Biella, , Italy
Ospedale Civile Ramazzini, Carpi, , Italy
Ospedale Civile S. Croce, Fano, , Italy
European Institute of Oncology, Milano, , Italy
Ospedale Civile Rimini, Rimini, , Italy
Ospedale Sant' Eugenio, Rome, , Italy
Centro Sociale Oncologico, Treste, , Italy
Policlinico Universitario Udine, Udine, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Auckland City Hospital, Auckland, , New Zealand
Institutul Oncologic - Universitatea de Medicina, Cluj-Napoca, , Romania
Institute of Oncology - Ljubljana, Ljubljana, , Slovenia
Sahlgrenska University Hospital, Gothenburg, , Sweden
Skaraborgs Hospital, Skovde, , Sweden
Kantonspital Aarau, Aarau, , Switzerland
Inselspital Bern, Bern, , Switzerland
Oncocare Sonnenhof-Klinik Engeriedspital, Bern, , Switzerland
Kantonsspital Graubuenden, Chur, , Switzerland
Ospedale Beata Vergine, Mendrisio, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Regionalspital, Thun, , Switzerland
Contact Details
Name: Diana Crivellari, MD
Affiliation: Centro di Riferimento Oncologico, Aviano (Italy)
Role: STUDY_CHAIR
Name: Silvia Dellapasqua, MD
Affiliation: European Institute of Oncology, Milano (Italy)
Role: STUDY_CHAIR
Name: Anne Hamilton, MD
Affiliation: Royal Prince Alfred Hospital, Camperdown (Australia)
Role: STUDY_CHAIR
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