Letrozole in Treating Women With Primary Breast Cancer Who Have Received 5 Years of Aromatase Inhibitor Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00754845|
Recruitment Status : Unknown
Verified March 2016 by Canadian Cancer Trials Group.
Recruitment status was: Active, not recruiting
First Posted : September 18, 2008
Last Update Posted : January 11, 2017
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating in women with breast cancer who have already received 5 years of aromatase inhibitor therapy.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating women with primary breast cancer who have received 5 years of aromatase inhibitor therapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: letrozole Other: placebo||Phase 3|
- To compare the disease-free survival of women with primary breast cancer treated with letrozole vs placebo after completing approximately 5 years (i.e., 4½ - 6 years) of aromatase inhibitor therapy (e.g., letrozole, anastrozole, or exemestane).
- To compare the effect of these drugs on overall (all cause specific) mortality of these patients.
- To compare the incidence of contralateral breast cancer in patients treated with these drugs.
- To evaluate the long-term clinical and laboratory safety of aromatase inhibitor therapy, particularly cardiovascular morbidity and mortality (e.g., significant coronary artery disease, including myocardial infarction and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes, and all vascular deaths); incidence of all bone fractures (with particular emphasis on hip and wrist fractures as indicators of osteoporosis); changes in bone density; and common toxicities.
- To compare overall quality of life (QOL) and menopausal-specific QOL of patients treated with these drugs.
OUTLINE: This is a multicenter study. Patients are stratified according to lymph node status at diagnosis (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), interval between last dose of aromatase inhibitor therapy and study randomization (< 6 months vs 6 months to 2 years), and duration of prior tamoxifen citrate use (0 vs < 2 years vs 2 - 4½ years vs > 4½ years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.
- Arm II: Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.
Patients undergo bone mineral density measurement by DEXA scan at baseline (if not done within 12 months of study entry), at 24 and 48 months during study therapy, and at the completion of study therapy. Some patients also complete quality-of-life questionnaires at baseline and at 12, 24, 36, 48, and 60 months.
After completion of study therapy, patients are followed annually.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1918 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed With Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in The MA.17 Study)|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||February 2017|
Experimental: Arm I
Patients receive oral letrozole once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.
Other Name: femara
Placebo Comparator: Arm II
Patients receive oral placebo once daily for up to 5 years in the absence of unacceptable toxicity, disease recurrence, or development of a second malignancy.
Other Name: sugar pill
- Disease-free survival [ Time Frame: 8 years ]
- Incidence of contralateral breast cancer [ Time Frame: 8 years ]
- Overall survival [ Time Frame: 8 years ]
- Long-term clinical and laboratory safety of aromatase inhibitor therapy, particularly cardiovascular morbidity and mortality, changes in bone mineral density, incidence of all bone fractures, and common toxicities [ Time Frame: 8 years ]
- Quality of life (QOL) as assessed by SF-36 Health Survey and the Menopause-Specific QOL Questionnaire (NCIC CTG participating centers) [ Time Frame: 8 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754845
Hide Study Locations
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|BCCA - Vancouver Island Cancer Centre|
|Victoria, British Columbia, Canada, V8R 6V5|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, New Brunswick|
|The Moncton Hospital|
|Moncton, New Brunswick, Canada, E1C 6Z8|
|The Vitalite Health Network - Dr. Leon Richard|
|Moncton, New Brunswick, Canada, E1C 8X3|
|Atlantic Health Sciences Corporation|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Canada, Newfoundland and Labrador|
|Dr. H. Bliss Murphy Cancer Centre|
|St. John's, Newfoundland and Labrador, Canada, AIB 3V6|
|Canada, Nova Scotia|
|QEII Health Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Credit Valley Hospital|
|Mississauga, Ontario, Canada, L5M 2N1|
|Stronach Regional Health Centre at Southlake|
|Newmarket, Ontario, Canada, L3Y 2P9|
|Lakeridge Health Oshawa|
|Oshawa, Ontario, Canada, L1G 2B9|
|Algoma District Cancer Program|
|Sault Ste. Marie, Ontario, Canada, P6B 0A8|
|Niagara Health System|
|St. Catharines, Ontario, Canada, L2R 7C6|
|Northeast Cancer Center Health Sciences|
|Sudbury, Ontario, Canada, P3E 5J1|
|Thunder Bay Regional Health Science Centre|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|North York General Hospital|
|Toronto, Ontario, Canada, M2K 1E1|
|Toronto East General Hospital|
|Toronto, Ontario, Canada, M4C 3E7|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|St. Joseph's Health Centre|
|Toronto, Ontario, Canada, M6R 1B5|
|Trillium Health Centre - West Toronto|
|Toronto, Ontario, Canada, M9C 1A5|
|Humber River Regional Hospital|
|Toronto, Ontario, Canada, M9N 1N8|
|Windsor Regional Cancer Centre|
|Windsor, Ontario, Canada, N8W 2X3|
|Canada, Prince Edward Island|
|PEI Cancer Treatment Centre,Queen Elizabeth Hospital|
|Charlottetown, Prince Edward Island, Canada, C1A 8T5|
|Centre de Sante et de services sociaux de Gatineau|
|Gatineau, Quebec, Canada, J8P 7H2|
|Hopital Charles LeMoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|L'Hotel-Dieu de Levis|
|Levis, Quebec, Canada, G6V 3Z1|
|Montreal, Quebec, Canada, H1T 2M4|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|CHUM - Hotel Dieu du Montreal|
|Montreal, Quebec, Canada, H2W 1T8|
|Hopital du Sacre-Coeur de Montreal|
|Montreal, Quebec, Canada, H4J 1C5|
|CHA-Hopital Du St-Sacrement|
|Quebec City, Quebec, Canada, G1S 4L8|
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Saskatoon Cancer Centre|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Manchester, United Kingdom, M23 9LT|
|Study Chair:||Paul E. Goss, MD, PhD||Massachusetts General Hospital|