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Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer

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: NCT00066573
Recruitment Status : Completed
First Posted : August 7, 2003
Results First Posted : May 15, 2014
Last Update Posted : April 8, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Southwest Oncology Group
International Breast Cancer Study Group
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: anastrozole
Drug: exemestane
Enrollment 7576
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exemestane Anastrozole
Hide Arm/Group Description

Patients receive oral exemestane (25 mg) once daily for 5 years.

exemestane: Given orally

Patients receive oral anastrozole (1 mg) once daily for 5 years.

anastrozole: Given orally

Period Title: Overall Study
Started 3789 3787
Completed 3761 3759
Not Completed 28 28
Reason Not Completed
Did not received protocol treatment             28             28
Arm/Group Title Exemestane Anastrozole Total
Hide Arm/Group Description

Patients receive oral exemestane (25 mg) once daily for 5 years.

exemestane: Given orally

Patients receive oral anastrozole (1 mg) once daily for 5 years.

anastrozole: Given orally

Total of all reporting groups
Overall Number of Baseline Participants 3789 3787 7576
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3789 participants 3787 participants 7576 participants
63.9
(35.9 to 93.6)
64.3
(32.3 to 95.1)
64.1
(32.3 to 95.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3789 participants 3787 participants 7576 participants
Female
3789
 100.0%
3787
 100.0%
7576
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Event-free Survival
Hide Description Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exemestane Anastrozole
Hide Arm/Group Description:

Patients receive oral exemestane (25 mg) once daily for 5 years.

exemestane: Given orally

Patients receive oral anastrozole (1 mg) once daily for 5 years.

anastrozole: Given orally

Overall Number of Participants Analyzed 3789 3787
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88
(87 to 89)
89
(88 to 90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Anastrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.87 to 1.18
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival: Percentage of Participants Alive at 5 Years
Hide Description Overall survival is defined as the time from randomization to the time of death from any cause.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intend to treat
Arm/Group Title Exemestane Anastrozole
Hide Arm/Group Description:

Patients receive oral exemestane (25 mg) once daily for 5 years.

exemestane: Given orally

Patients receive oral anastrozole (1 mg) once daily for 5 years.

anastrozole: Given orally

Overall Number of Participants Analyzed 3789 3787
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
92
(91 to 93)
92
(91 to 93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exemestane, Anastrozole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments No power calculation for secondary analysis
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.77 to 1.13
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence
Hide Description Time to distant disease-free survival (DDFS) is defined as the time from randomization to the time of documented distant recurrence. Distant recurrence is the cancer coming back in a part of the body away from the breast, such as the bones or liver.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat
Arm/Group Title Exemestane Anastrozole
Hide Arm/Group Description:

Patients receive oral exemestane (25 mg) once daily for 5 years.

exemestane: Given orally

Patients receive oral anastrozole (1 mg) once daily for 5 years.

anastrozole: Given orally

Overall Number of Participants Analyzed 3789 3787
Measure Type: Count of Participants
Unit of Measure: Participants
157
   4.1%
164
   4.3%
4.Secondary Outcome
Title Clinical Fracture Rate: Number of Participants With Bone Fractures.
Hide Description Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.
Time Frame 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exemestane Anastrozole
Hide Arm/Group Description:

Patients receive oral exemestane (25 mg) once daily for 5 years.

exemestane: Given orally

Patients receive oral anastrozole (1 mg) once daily for 5 years.

anastrozole: Given orally

Overall Number of Participants Analyzed 3789 3787
Measure Type: Count of Participants
Unit of Measure: Participants
358
   9.4%
354
   9.3%
Time Frame 8 years
Adverse Event Reporting Description Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
 
Arm/Group Title Exemestane Anastrozole
Hide Arm/Group Description

Patients receive oral exemestane (25 mg) once daily for 5 years.

exemestane: Given orally

Patients receive oral anastrozole (1 mg) once daily for 5 years.

anastrozole: Given orally

All-Cause Mortality
Exemestane Anastrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Exemestane Anastrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   19/3761 (0.51%)   7/3759 (0.19%) 
Cardiac disorders     
Cardiac ischemia/infarction  1  3/3761 (0.08%)  0/3759 (0.00%) 
Left ventricular systolic dysfunction  1  1/3761 (0.03%)  0/3759 (0.00%) 
Restrictive cardiomyopathy  1  1/3761 (0.03%)  0/3759 (0.00%) 
Supraven.arrhyth. Atrial flutter  1  1/3761 (0.03%)  0/3759 (0.00%) 
Ventric.arrhyth. Trigeminy  1  1/3761 (0.03%)  0/3759 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  0/3761 (0.00%)  1/3759 (0.03%) 
Eye disorders     
Blurred vision  1  1/3761 (0.03%)  0/3759 (0.00%) 
Nyctalopia  1  0/3761 (0.00%)  1/3759 (0.03%) 
Ocular - Other  1  1/3761 (0.03%)  0/3759 (0.00%) 
Retinopathy  1  1/3761 (0.03%)  0/3759 (0.00%) 
General disorders     
Fatigue  1  1/3761 (0.03%)  0/3759 (0.00%) 
Immune system disorders     
Allergic reaction  1  1/3761 (0.03%)  0/3759 (0.00%) 
Investigations     
Bilirubin  1  1/3761 (0.03%)  0/3759 (0.00%) 
Creatinine  1  1/3761 (0.03%)  0/3759 (0.00%) 
cTnI  1  1/3761 (0.03%)  0/3759 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteonecrosis  1  1/3761 (0.03%)  0/3759 (0.00%) 
Nervous system disorders     
CNS ischemia  1  3/3761 (0.08%)  1/3759 (0.03%) 
Neurology - Other  1  1/3761 (0.03%)  0/3759 (0.00%) 
Neuropathy-motor  1  0/3761 (0.00%)  1/3759 (0.03%) 
Neuropathy: cranial CN VIII  1  1/3761 (0.03%)  0/3759 (0.00%) 
Speech impairment  1  0/3761 (0.00%)  1/3759 (0.03%) 
Syncope  1  0/3761 (0.00%)  2/3759 (0.05%) 
Psychiatric disorders     
Confusion  1  1/3761 (0.03%)  0/3759 (0.00%) 
Renal and urinary disorders     
Incontinence, urinary  1  0/3761 (0.00%)  1/3759 (0.03%) 
Renal failure  1  2/3761 (0.05%)  0/3759 (0.00%) 
Vascular disorders     
Thrombosis/thrombus/embolism  1  3/3761 (0.08%)  1/3759 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exemestane Anastrozole
Affected / at Risk (%) Affected / at Risk (%)
Total   3556/3761 (94.55%)   3543/3759 (94.25%) 
Gastrointestinal disorders     
Constipation  1  614/3761 (16.33%)  606/3759 (16.12%) 
Diarrhea  1  464/3761 (12.34%)  414/3759 (11.01%) 
Flatulence  1  399/3761 (10.61%)  363/3759 (9.66%) 
Heartburn  1  574/3761 (15.26%)  556/3759 (14.79%) 
Nausea  1  436/3761 (11.59%)  442/3759 (11.76%) 
Pain Abdomen NOS  1  202/3761 (5.37%)  220/3759 (5.85%) 
General disorders     
Edema: limb  1  749/3761 (19.91%)  760/3759 (20.22%) 
Fatigue  1  1697/3761 (45.12%)  1749/3759 (46.53%) 
Injury, poisoning and procedural complications     
Fracture  1  290/3761 (7.71%)  292/3759 (7.77%) 
Investigations     
Cholesterol  1  591/3761 (15.71%)  677/3759 (18.01%) 
Weight gain  1  257/3761 (6.83%)  286/3759 (7.61%) 
Weight loss  1  229/3761 (6.09%)  218/3759 (5.80%) 
Metabolism and nutrition disorders     
Anorexia  1  238/3761 (6.33%)  249/3759 (6.62%) 
Hyperglycemia  1  347/3761 (9.23%)  373/3759 (9.92%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  264/3761 (7.02%)  242/3759 (6.44%) 
Osteoporosis  1  1243/3761 (33.05%)  1369/3759 (36.42%) 
Pain Back  1  480/3761 (12.76%)  504/3759 (13.41%) 
Pain Bone  1  381/3761 (10.13%)  410/3759 (10.91%) 
Pain Extremity-limb  1  468/3761 (12.44%)  511/3759 (13.59%) 
Pain Joint  1  2085/3761 (55.44%)  2086/3759 (55.49%) 
Pain Muscle  1  667/3761 (17.73%)  629/3759 (16.73%) 
Nervous system disorders     
Dizziness  1  526/3761 (13.99%)  504/3759 (13.41%) 
Neuropathy-sensory  1  576/3761 (15.32%)  528/3759 (14.05%) 
Pain Head/headache  1  414/3761 (11.01%)  399/3759 (10.61%) 
Psychiatric disorders     
Insomnia  1  574/3761 (15.26%)  521/3759 (13.86%) 
Mood alteration Anxiety  1  258/3761 (6.86%)  229/3759 (6.09%) 
Mood alteration Depression  1  374/3761 (9.94%)  377/3759 (10.03%) 
Reproductive system and breast disorders     
Pain Breast  1  288/3761 (7.66%)  312/3759 (8.30%) 
Vaginal dryness  1  248/3761 (6.59%)  260/3759 (6.92%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  671/3761 (17.84%)  666/3759 (17.72%) 
Dyspnea  1  656/3761 (17.44%)  652/3759 (17.35%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  235/3761 (6.25%)  212/3759 (5.64%) 
Rash  1  474/3761 (12.60%)  437/3759 (11.63%) 
Sweating  1  626/3761 (16.64%)  603/3759 (16.04%) 
Vascular disorders     
Hot flashes  1  2086/3761 (55.46%)  2138/3759 (56.88%) 
Hypertension  1  300/3761 (7.98%)  326/3759 (8.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Wendy Parulekar
Organization: NCIC Clinical Trials Group
Phone: 1-613-533-6430
EMail: wparulekar@ctg.queensu.ca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
ClinicalTrials.gov Identifier: NCT00066573    
Obsolete Identifiers: NCT00438529
Other Study ID Numbers: MA27
CAN-NCIC-MA27 ( Other Identifier: Cancer.gov )
NCCTG-MA27 ( Other Identifier: NCCTG )
CALGB-CAN-NCIC-MA27 ( Other Identifier: CALGB )
ECOG-CAN-NCIC-MA27 ( Other Identifier: ECOG )
SWOG-CAN-NCIC-MA27 ( Other Identifier: SWOG )
IBCSG-30-04 ( Other Identifier: IBCSG )
2005-001893-28 ( EudraCT Number )
CDR0000316325 ( Other Identifier: PDQ )
First Submitted: August 6, 2003
First Posted: August 7, 2003
Results First Submitted: April 16, 2014
Results First Posted: May 15, 2014
Last Update Posted: April 8, 2020