Letrozole After Tamoxifen in Treating Women With Breast Cancer
NCT ID: NCT00003140
Last Updated: 2020-09-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
5187 participants
Study Classification
INTERVENTIONAL
Study Start Date
1998-08-24
Study Completion Date
2003-10-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Arm I
Patients receive oral letrozole once daily.
Group Type
EXPERIMENTAL
letrozole
Intervention Type
DRUG
Given orally
Arm II
Patients receive oral placebo once daily.
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
OTHER
Given orally
Interventions
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letrozole
Given orally
Intervention Type
DRUG
placebo
Given orally
Intervention Type
OTHER
Other Intervention Names
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Femara
Eligibility Criteria
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Inclusion Criteria
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis
* No ductal carcinoma in situ
* Axillary lymph node negative, positive, or unknown
* No evidence of metastases
* No localized or distant breast cancer recurrence
* Not registered on protocol NCCTG-893052, any other IBCSG protocol, or protocol SWOG-S9623
* Hormone receptor status:
* Estrogen or progesterone receptor positive as defined by tumor receptor content at least 10 fmol/mg protein or receptor positive by ERICA or PgRICA
* Unknown status allowed if effort to determine status has been made by immunocytochemistry
* No contralateral breast cancer
PATIENT CHARACTERISTICS:
Age:
* Postmenopausal
Sex:
* Female
Menopausal status:
* Postmenopausal defined by one of the following:
* Age 50 or over at start of adjuvant tamoxifen
* Under age 50 and considered postmenopausal by treating physician at start of adjuvant tamoxifen
* Under age 50 at start of adjuvant tamoxifen and had bilateral oophorectomy (surgical or radiation)
* Under age 50 and premenopausal at start of adjuvant tamoxifen, but became amenorrheic during tamoxifen and remained amenorrheic for at least 1 year
* Considered postmenopausal by physician with LH/FSH levels under the treatment center's postmenopausal limits
Performance status:
* ECOG 0-2
Life expectancy:
* At least 5 years
Hematopoietic:
* WBC ≥ 3,000/mm\^3 OR
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic:
* AST and/or ALT \< 2 times upper limit of normal (ULN) (unless imaging examinations have ruled out metastatic disease)
* Alkaline phosphatase \< 2 times ULN (unless imaging examinations have ruled out metastatic disease)
Renal:
* Not specified
Other:
* No concurrent medical or psychiatric condition that would preclude study participation
* No other malignancy within the past 5 years except adequately treated superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* Able to swallow study drug
* Adequate oral intake
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior adjuvant chemotherapy allowed
* No concurrent chemotherapy
Endocrine therapy:
* Completed at least 4.5 but no more than 6 years of adjuvant tamoxifen after resection
* Completed at least 4.5-6 years of adjuvant aromatase inhibitor as initial therapy or after tamoxifen
* No more than 3 months since prior adjuvant tamoxifen
* No concurrent hormone replacement therapy (e.g., megestrol)
* No concurrent selective estrogen-receptor modulators (e.g., raloxifene or idoxifene)
* Concurrent intermittent vaginal estrogens (e.g., Estring) allowed if other local measures for intractable vaginal atrophy are insufficient
* No other concurrent aromatase inhibitors
* No more than 2 years since prior aromatase inhibitor therapy (re-randomization)
Radiotherapy:
* Prior radiotherapy allowed
Surgery:
* See Disease Characteristics
Other:
* At least 1 month since prior investigational drugs
* Prior treatment on a clinical trial for breast cancer allowed if permission has been obtained from the sponsors of the original study for their patient to participate on MA.17/JMA.17/BIG-97-01
* No prior placebo on core protocol
* No concurrent anticancer therapy
* Concurrent thyroid medication, calcium, vitamin D, and bisphosphonates allowed
* Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis
* No ductal carcinoma in situ
* Axillary lymph node negative, positive, or unknown
* No evidence of metastases
* No localized or distant breast cancer recurrence
* Not registered on protocol NCCTG-893052, any other IBCSG protocol, or protocol SWOG-S9623
* Hormone receptor status:
* Estrogen or progesterone receptor positive as defined by tumor receptor content at least 10 fmol/mg protein or receptor positive by ERICA or PgRICA
* Unknown status allowed if effort to determine status has been made by immunocytochemistry
* No contralateral breast cancer
PATIENT CHARACTERISTICS:
Age:
* Postmenopausal
Sex:
* Female
Menopausal status:
* Postmenopausal defined by one of the following:
* Age 50 or over at start of adjuvant tamoxifen
* Under age 50 and considered postmenopausal by treating physician at start of adjuvant tamoxifen
* Under age 50 at start of adjuvant tamoxifen and had bilateral oophorectomy (surgical or radiation)
* Under age 50 and premenopausal at start of adjuvant tamoxifen, but became amenorrheic during tamoxifen and remained amenorrheic for at least 1 year
* Considered postmenopausal by physician with LH/FSH levels under the treatment center's postmenopausal limits
Performance status:
* ECOG 0-2
Life expectancy:
* At least 5 years
Hematopoietic:
* WBC ≥ 3,000/mm\^3 OR
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic:
* AST and/or ALT \< 2 times upper limit of normal (ULN) (unless imaging examinations have ruled out metastatic disease)
* Alkaline phosphatase \< 2 times ULN (unless imaging examinations have ruled out metastatic disease)
Renal:
* Not specified
Other:
* No concurrent medical or psychiatric condition that would preclude study participation
* No other malignancy within the past 5 years except adequately treated superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* Able to swallow study drug
* Adequate oral intake
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior adjuvant chemotherapy allowed
* No concurrent chemotherapy
Endocrine therapy:
* Completed at least 4.5 but no more than 6 years of adjuvant tamoxifen after resection
* Completed at least 4.5-6 years of adjuvant aromatase inhibitor as initial therapy or after tamoxifen
* No more than 3 months since prior adjuvant tamoxifen
* No concurrent hormone replacement therapy (e.g., megestrol)
* No concurrent selective estrogen-receptor modulators (e.g., raloxifene or idoxifene)
* Concurrent intermittent vaginal estrogens (e.g., Estring) allowed if other local measures for intractable vaginal atrophy are insufficient
* No other concurrent aromatase inhibitors
* No more than 2 years since prior aromatase inhibitor therapy (re-randomization)
Radiotherapy:
* Prior radiotherapy allowed
Surgery:
* See Disease Characteristics
Other:
* At least 1 month since prior investigational drugs
* Prior treatment on a clinical trial for breast cancer allowed if permission has been obtained from the sponsors of the original study for their patient to participate on MA.17/JMA.17/BIG-97-01
* No prior placebo on core protocol
* No concurrent anticancer therapy
* Concurrent thyroid medication, calcium, vitamin D, and bisphosphonates allowed
Minimum Eligible Age
0 Years
Maximum Eligible Age
120 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
North Central Cancer Treatment Group
NETWORK
Sponsor Role
collaborator
ETOP IBCSG Partners Foundation
NETWORK
Sponsor Role
collaborator
Eastern Cooperative Oncology Group
NETWORK
Sponsor Role
collaborator
SWOG Cancer Research Network
NETWORK
Sponsor Role
collaborator
Cancer and Leukemia Group B
NETWORK
Sponsor Role
collaborator
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Sponsor Role
collaborator
NCIC Clinical Trials Group
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Paul E. Goss, MD, PhD
Role: STUDY_CHAIR
Massachusetts General Hospital
James N. Ingle, MD
Role: STUDY_CHAIR
Mayo Clinic
Monica Castiglione-Gertsch, MD
Role: STUDY_CHAIR
Insel Gruppe AG, University Hospital Bern
Nicholas J. Robert, MD
Role: STUDY_CHAIR
Fairfax Northern Virginia Hematology Oncology, PC - Fairfax
Silvana Martino, DO
Role: STUDY_CHAIR
Saint John's Cancer Institute
Hyman B. Muss, MD
Role: STUDY_CHAIR
University of Vermont
Martine J. Piccart-Gebhart, MD, PhD
Role: STUDY_CHAIR
Jules Bordet Institute
Locations
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Lethbridge Cancer Centre
Lethbridge, Alberta, Canada
Site Status
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
Site Status
NRGH - Nanaimo Cancer Clinic
Nanaimo, British Columbia, Canada
Site Status
Penticton Regional Hospital
Penticton, British Columbia, Canada
Site Status
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
Site Status
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Site Status
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
Site Status
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Site Status
The Moncton Hospital
Moncton, New Brunswick, Canada
Site Status
The Vitalite Health Network - Dr. Leon Richard
Moncton, New Brunswick, Canada
Site Status
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada
Site Status
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
Site Status
QEII Health Sciences Center
Halifax, Nova Scotia, Canada
Site Status
The Royal Victoria Hospital
Barrie, Ontario, Canada
Site Status
Regional Cancer Program of the Hopital Regional
Greater Sudbury, Ontario, Canada
Site Status
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Site Status
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
Site Status
London Regional Cancer Program
London, Ontario, Canada
Site Status
Markham Stouffville Hospital
Markham, Ontario, Canada
Site Status
Credit Valley Hospital
Mississauga, Ontario, Canada
Site Status
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, Canada
Site Status
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Site Status
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada
Site Status
Peterborough Regional Health Centre
Peterborough, Ontario, Canada
Site Status
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada
Site Status
Niagara Health System
St. Catharines, Ontario, Canada
Site Status
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada
Site Status
North York General Hospital
Toronto, Ontario, Canada
Site Status
Toronto East General Hospital
Toronto, Ontario, Canada
Site Status
Odette Cancer Centre
Toronto, Ontario, Canada
Site Status
St. Michael's Hospital
Toronto, Ontario, Canada
Site Status
Mount Sinai Hospital
Toronto, Ontario, Canada
Site Status
Univ. Health Network-The Toronto General Hospital
Toronto, Ontario, Canada
Site Status
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Site Status
St. Joseph's Health Centre
Toronto, Ontario, Canada
Site Status
Trillium Health Centre - West Toronto
Toronto, Ontario, Canada
Site Status
Humber River Regional Hospital
Toronto, Ontario, Canada
Site Status
Windsor Regional Cancer Centre
Windsor, Ontario, Canada
Site Status
PEI Cancer Treatment Centre,Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada
Site Status
Centre de Sante et de services sociaux de Gatineau
Gatineau, Quebec, Canada
Site Status
L'Hotel-Dieu de Levis
Lévis, Quebec, Canada
Site Status
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Site Status
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada
Site Status
McGill University - Dept. Oncology
Montreal, Quebec, Canada
Site Status
CHUM - Hotel Dieu du Montreal
Montreal, Quebec, Canada
Site Status
CHUM - Pavillon Saint-Luc
Montreal, Quebec, Canada
Site Status
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Site Status
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, Canada
Site Status
CHA-Hopital Du St-Sacrement
Québec, Quebec, Canada
Site Status
University Institute of Cardiology and
Québec, Quebec, Canada
Site Status
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Site Status
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Site Status
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Site Status
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Site Status
Wythenshawe Hospital
Manchester, , United Kingdom
Site Status
Christie's Hospital NHS Trust
Manchester, , United Kingdom
Site Status
The Royal Marsden NHS Foundation Trust - Sutton
Surrey, , United Kingdom
Site Status
Countries
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Canada
United Kingdom
References
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Baum M. Adjuvant endocrine therapy in postmenopausal women with early breast cancer: where are we now? Eur J Cancer. 2005 Aug;41(12):1667-77. doi: 10.1016/j.ejca.2005.05.006.
Reference Type
BACKGROUND
Baum M. Current status of aromatase inhibitors in the management of breast cancer and critique of the NCIC MA-17 trial. Cancer Control. 2004 Jul-Aug;11(4):217-21. doi: 10.1177/107327480401100402.
Reference Type
BACKGROUND
Booth CM, Pater JL, Goss PE. Identifying breast cancer patients most likely to benefit from aromatase inhibitor therapy after adjuvant tamoxifen. Cancer. 2007 May 1;109(9):1927-8; author reply 1928. doi: 10.1002/cncr.22613. No abstract available.
Reference Type
BACKGROUND
Buzdar A, Chlebowski R, Cuzick J, Duffy S, Forbes J, Jonat W, Ravdin P. Defining the role of aromatase inhibitors in the adjuvant endocrine treatment of early breast cancer. Curr Med Res Opin. 2006 Aug;22(8):1575-85. doi: 10.1185/030079906X120940.
Reference Type
BACKGROUND
Scott LJ, Keam SJ. Letrozole : in postmenopausal hormone-responsive early-stage breast cancer. Drugs. 2006;66(3):353-62. doi: 10.2165/00003495-200666030-00010.
Reference Type
BACKGROUND
Vakaet L. Re: Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2006 Aug 16;98(16):1162; author reply 1162-3. doi: 10.1093/jnci/djj323. No abstract available.
Reference Type
BACKGROUND
Wardley AM. Emerging data on optimal adjuvant endocrine therapy: Breast International Group trial 1-98/MA.17. Clin Breast Cancer. 2006 Feb;6 Suppl 2:S45-50. doi: 10.3816/cbc.2006.s.003.
Reference Type
BACKGROUND
Goss PE, Ingle JN, Martino S, et al.: Outcomes of women who were premenopausal at diagnosis of early stage breast cancer in the NCIC CTG MA17 trial. [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-13, 2009.
Reference Type
RESULT
Goss PE, Ingle JN, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Tu D. Late extended adjuvant treatment with letrozole improves outcome in women with early-stage breast cancer who complete 5 years of tamoxifen. J Clin Oncol. 2008 Apr 20;26(12):1948-55. doi: 10.1200/JCO.2007.11.6798. Epub 2008 Mar 10.
Reference Type
RESULT
Ingle JN, Tu D, Pater JL, Muss HB, Martino S, Robert NJ, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Goss PE. Intent-to-treat analysis of the placebo-controlled trial of letrozole for extended adjuvant therapy in early breast cancer: NCIC CTG MA.17. Ann Oncol. 2008 May;19(5):877-82. doi: 10.1093/annonc/mdm566. Epub 2008 Mar 10.
Reference Type
RESULT
Muss HB, Tu D, Ingle JN, Martino S, Robert NJ, Pater JL, Whelan TJ, Palmer MJ, Piccart MJ, Shepherd LE, Pritchard KI, He Z, Goss PE. Efficacy, toxicity, and quality of life in older women with early-stage breast cancer treated with letrozole or placebo after 5 years of tamoxifen: NCIC CTG intergroup trial MA.17. J Clin Oncol. 2008 Apr 20;26(12):1956-64. doi: 10.1200/JCO.2007.12.6334. Epub 2008 Mar 10.
Reference Type
RESULT
Chapman JW, Meng D, Shepherd L, et al.: Competing causes of death in breast cancer extended adjuvant endocrine therapy: NCIC CTG MA.17. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-56, 2007.
Reference Type
RESULT
Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL; National Cancer Institute of Canada Clinical Trials Group MA.17. Efficacy of letrozole extended adjuvant therapy according to estrogen receptor and progesterone receptor status of the primary tumor: National Cancer Institute of Canada Clinical Trials Group MA.17. J Clin Oncol. 2007 May 20;25(15):2006-11. doi: 10.1200/JCO.2006.09.4482. Epub 2007 Apr 23.
Reference Type
RESULT
Goss P: Breaking the 5-year barrier: results from the MA.17 extended adjuvant trial in women who have completed adjuvant tamoxifen treatment. [Abstract] European Journal of Cancer Supplements 4 (9): 10-5, 2006.
Reference Type
RESULT
Ingle JN, Tu D, Pater JL, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Goss PE. Duration of letrozole treatment and outcomes in the placebo-controlled NCIC CTG MA.17 extended adjuvant therapy trial. Breast Cancer Res Treat. 2006 Oct;99(3):295-300. doi: 10.1007/s10549-006-9207-y. Epub 2006 Mar 16.
Reference Type
RESULT
Ingle J, Tu D, Shepherd L, et al.: NCIC CTG MA.17: intent to treat analysis (ITT) of randomized patients after a median follow-up of 54 months. [Abstract] J Clin Oncol 24 (Suppl 18): A-549, 2006.
Reference Type
RESULT
Moy B, Tu D, Shepherd LE, et al.: NCIC CTG MA.17: tolerability of letrozole among ethnic minority women. [Abstract] J Clin Oncol 24 (Suppl 18): A-6018, 305s, 2006.
Reference Type
RESULT
Pater JL, Tu D, Ingle JN, et al.: An evaluation of the early termination (ET) of MA.17 extended adjuvant therapy trial. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2081, S107-8, 2006.
Reference Type
RESULT
Perez EA, Josse RG, Pritchard KI, Ingle JN, Martino S, Findlay BP, Shenkier TN, Tozer RG, Palmer MJ, Shepherd LE, Liu S, Tu D, Goss PE. Effect of letrozole versus placebo on bone mineral density in women with primary breast cancer completing 5 or more years of adjuvant tamoxifen: a companion study to NCIC CTG MA.17. J Clin Oncol. 2006 Aug 1;24(22):3629-35. doi: 10.1200/JCO.2005.05.4882. Epub 2006 Jul 5.
Reference Type
RESULT
Robert NJ, Goss PE, Ingle JN, et al.: Updated analysis of NCIC CTG MA.17 (letrozole vs. placebo to letrozole vs placebo) post unblinding. [Abstract] J Clin Oncol 24 (Suppl 18): A-550, 2006.
Reference Type
RESULT
Abetz L, Barghout V, Thomas S, et al.: Letrozole did not worsen quality of life relative to placebo in post-menopausal women with early breast cancer: results from the US subjects of the MA-17 study. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-2047, 2005.
Reference Type
RESULT
Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2005 Sep 7;97(17):1262-71. doi: 10.1093/jnci/dji250.
Reference Type
RESULT
Goss PE, Ingle JN, Palmer MJ, et al.: Updated analysis of NCIC CTG MA.17 (letrozole vs. placebo to letrozole vs placebo) post unblinding. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-16, 2005.
Reference Type
RESULT
Goss PE, Ingle JN, Tu D: NCIC CTG MA17: disease free survival according to estrogen receptor and progesterone receptor status of the primary tumor. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-2042, 2005.
Reference Type
RESULT
Ingle JN, Goss PE, Tu D: Analysis of duration of letrozole extended adjuvant therapy as measured by hazard ratios of disease recurrence over time for patients on NCIC CTG MA.17. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-17, 2005.
Reference Type
RESULT
Luk C, Goss P, Pritchard K, et al.: Determinants of preferences for starting extended adjuvant letrozole (L) in postmenopausal women following five years of tamoxifen. [Abstract] J Clin Oncol 23 (Suppl 16): A-642, 39s, 2005.
Reference Type
RESULT
Vachon CM, Ingle JN, Scott CG, et al.: Pilot study of changes in mammographic density in women treated with letrozole or placebo on NCIC CTG MA17. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-6005, 2005.
Reference Type
RESULT
Whelan TJ, Goss PE, Ingle JN, Pater JL, Tu D, Pritchard K, Liu S, Shepherd LE, Palmer M, Robert NJ, Martino S, Muss HB. Assessment of quality of life in MA.17: a randomized, placebo-controlled trial of letrozole after 5 years of tamoxifen in postmenopausal women. J Clin Oncol. 2005 Oct 1;23(28):6931-40. doi: 10.1200/JCO.2005.11.181. Epub 2005 Sep 12.
Reference Type
RESULT
Goss PE, Ingle JN, Martino S, et al.: Updated analysis of the NCIC CTG MA.17 randomized placebo (P) controlled trial of letrozole (L) after five years of tamoxifen in postmenopausal women with early stage breast cancer. [Abstract] J Clin Oncol 22 (Suppl 14): A-847, 88s, 2004.
Reference Type
RESULT
Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. doi: 10.1056/NEJMoa032312. Epub 2003 Oct 9.
Reference Type
RESULT
Ethier JL, Anderson GM, Austin PC, Clemons M, Parulekar W, Shepherd L, Summers Trasiewicz L, Tu D, Amir E. Influence of the competing risk of death on estimates of disease recurrence in trials of adjuvant endocrine therapy for early-stage breast cancer: A secondary analysis of MA.27, MA.17 and MA.17R. Eur J Cancer. 2021 May;149:117-127. doi: 10.1016/j.ejca.2021.02.034. Epub 2021 Apr 11.
Reference Type
DERIVED
Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. N Engl J Med. 2016 Jul 21;375(3):209-19. doi: 10.1056/NEJMoa1604700. Epub 2016 Jun 5.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAN-NCIC-MA17
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-49805
Identifier Type: -
Identifier Source: secondary_id
E-JMA17
Identifier Type: -
Identifier Source: secondary_id
EORTC-10983
Identifier Type: -
Identifier Source: secondary_id
IBCSG-BIG97-01
Identifier Type: -
Identifier Source: secondary_id
NCCTG-JMA17
Identifier Type: -
Identifier Source: secondary_id
SWOG-JMA17
Identifier Type: -
Identifier Source: secondary_id
JRF-Vor-Int-10
Identifier Type: -
Identifier Source: secondary_id
NCCTG-CAN-MA17
Identifier Type: -
Identifier Source: secondary_id
SWOG-CAN-MA17
Identifier Type: -
Identifier Source: secondary_id
CDR0000065921
Identifier Type: OTHER
Identifier Source: secondary_id
MA17
Identifier Type: -
Identifier Source: org_study_id
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