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Brief Title: Letrozole After Tamoxifen in Treating Women With Breast Cancer
Official Title: A Phase III Randomized Double Blind Study of Letrozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen
Study ID: NCT00003140
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
Detailed Description: OBJECTIVES: Primary * Compare the disease-free survival and overall survival of postmenopausal women with primary breast cancer who have completed at least five years of adjuvant aromatase inhibitor as initial therapy or after tamoxifen treated with letrozole or placebo. Secondary * Compare the incidence of contralateral breast cancer in patients treated with these regimens. * Evaluate the long-term clinical and laboratory safety of letrozole, in terms of lipid profile, cardiovascular morbidity and mortality, incidence of bone fractures, change in bone density, and common toxic effects, in this patient population. * Compare the quality of life of patients treated with these regimens. Re-randomization Primary * Compare disease-free survival of patients who, after receiving at least 4.5 years of letrozole, are re-randomized to receive an additional 5 years of letrozole vs placebo. Secondary * Determine whether common genetic polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for letrozole contribute to individual variation in toxicity and efficacy of letrozole therapy. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to receptor status (positive vs unknown), lymph node status (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), interval between last dose of aromatase inhibitor therapy and randomization (\< 6 months vs 6 months-2 years), and duration of prior tamoxifen use (0 years vs \< 2 years vs 2-4.5 years vs \> 4.5 years). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral letrozole once daily. * Arm II: Patients receive oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease progression or unacceptable toxicity. Patients in arm II may then be offered oral letrozole once daily for up to 5 years. Quality of life is assessed at baseline, at 6 months, and then annually for 4.5 years. * Double-blind, re-randomization: Patients who complete ≥ 4.5 years of letrozole (arm I) and who did not experience recurrent disease or new primary breast cancer, including ductal carcinoma in situ, may participate in the double-blind, placebo-controlled, re-randomization portion of the study. Patients are stratified according to lymph node status at enrollment (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and interval between last dose of letrozole and re-randomization (\<6 months vs 6 months to 2 years). Common genetic single nucleotide polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for letrozole are analyzed in order to determine if these single nucleotide polymorphisms contribute to individual variation in toxicity and efficacy of letrozole therapy. Quality of life is assessed as during the first randomization. Patients are followed annually. PROJECTED ACCRUAL: A total of 4,700 patients will be accrued for this study.
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Lethbridge Cancer Centre, Lethbridge, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
NRGH - Nanaimo Cancer Clinic, Nanaimo, British Columbia, Canada
Penticton Regional Hospital, Penticton, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
The Moncton Hospital, Moncton, New Brunswick, Canada
The Vitalite Health Network - Dr. Leon Richard, Moncton, New Brunswick, Canada
Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Center, Halifax, Nova Scotia, Canada
The Royal Victoria Hospital, Barrie, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Markham Stouffville Hospital, Markham, Ontario, Canada
Credit Valley Hospital, Mississauga, Ontario, Canada
Stronach Regional Health Centre at Southlake, Newmarket, Ontario, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Ottawa Health Research Institute - General Division, Ottawa, Ontario, Canada
Peterborough Regional Health Centre, Peterborough, Ontario, Canada
Algoma District Cancer Program, Sault Ste. Marie, Ontario, Canada
Niagara Health System, St. Catharines, Ontario, Canada
Regional Cancer Program of the Hopital Regional, Sudbury, Ontario, Canada
Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario, Canada
North York General Hospital, Toronto, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Odette Cancer Centre, Toronto, Ontario, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Univ. Health Network-The Toronto General Hospital, Toronto, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
St. Joseph's Health Centre, Toronto, Ontario, Canada
Trillium Health Centre - West Toronto, Toronto, Ontario, Canada
Humber River Regional Hospital, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
PEI Cancer Treatment Centre,Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, Canada
Centre de Sante et de services sociaux de Gatineau, Gatineau, Quebec, Canada
L'Hotel-Dieu de Levis, Levis, Quebec, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
McGill University - Dept. Oncology, Montreal, Quebec, Canada
CHUM - Hotel Dieu du Montreal, Montreal, Quebec, Canada
CHUM - Pavillon Saint-Luc, Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec, Quebec City, Quebec, Canada
CHA-Hopital Du St-Sacrement, Quebec City, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
University Institute of Cardiology and, Quebec, , Canada
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Wythenshawe Hospital, Manchester, , United Kingdom
Christie's Hospital NHS Trust, Manchester, , United Kingdom
The Royal Marsden NHS Foundation Trust - Sutton, Surrey, , United Kingdom
Name: Paul E. Goss, MD, PhD
Affiliation: Massachusetts General Hospital
Role: STUDY_CHAIR
Name: James N. Ingle, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
Name: Monica Castiglione-Gertsch, MD
Affiliation: Insel Gruppe AG, University Hospital Bern
Role: STUDY_CHAIR
Name: Nicholas J. Robert, MD
Affiliation: Fairfax Northern Virginia Hematology Oncology, PC - Fairfax
Role: STUDY_CHAIR
Name: Silvana Martino, DO
Affiliation: Saint John's Cancer Institute
Role: STUDY_CHAIR
Name: Hyman B. Muss, MD
Affiliation: University of Vermont
Role: STUDY_CHAIR
Name: Martine J. Piccart-Gebhart, MD, PhD
Affiliation: Jules Bordet Institute
Role: STUDY_CHAIR