Trial Outcomes & Findings for Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer (NCT NCT00066573)

Last Updated: 2023-08-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

7576 participants

Primary outcome timeframe

5 years

Results posted on

2023-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	Exemestane Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
Overall Study STARTED	3789	3787
Overall Study COMPLETED	3761	3759
Overall Study NOT COMPLETED	28	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Exemestane Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
Overall Study Did not received protocol treatment	28	28

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exemestane n=3789 Participants Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole n=3787 Participants Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally	Total n=7576 Participants Total of all reporting groups
Age, Continuous	63.9 years n=5 Participants	64.3 years n=7 Participants	64.1 years n=5 Participants
Sex: Female, Male Female	3789 Participants n=5 Participants	3787 Participants n=7 Participants	7576 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Outcome measures

Outcome measures
Measure	Exemestane n=3789 Participants Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole n=3787 Participants Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
Event-free Survival	88 percentage of participants Interval 87.0 to 89.0	89 percentage of participants Interval 88.0 to 90.0

SECONDARY outcome

Timeframe: 5 years

Population: Intend to treat

Overall survival is defined as the time from randomization to the time of death from any cause.

Outcome measures

Outcome measures
Measure	Exemestane n=3789 Participants Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole n=3787 Participants Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
Overall Survival: Percentage of Participants Alive at 5 Years	92 Percentage of Participants Interval 91.0 to 93.0	92 Percentage of Participants Interval 91.0 to 93.0

SECONDARY outcome

Timeframe: 5 years

Population: Intent to treat

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.

Outcome measures

Outcome measures
Measure	Exemestane n=3789 Participants Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole n=3787 Participants Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence	157 Participants	164 Participants

SECONDARY outcome

Timeframe: 8 years

Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.

Outcome measures

Outcome measures
Measure	Exemestane n=3789 Participants Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole n=3787 Participants Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
Clinical Fracture Rate: Number of Participants With Bone Fractures.	358 Participants	354 Participants

Adverse Events

Exemestane

Serious events: 19 serious events

Other events: 3556 other events

Deaths: 0 deaths

Anastrozole

Serious events: 7 serious events

Other events: 3543 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Wendy Parulekar

NCIC Clinical Trials Group

Phone: 1-613-533-6430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Exemestane n=3761 participants at risk Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole n=3759 participants at risk Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
Cardiac disorders Cardiac ischemia/infarction	0.08% 3/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Cardiac disorders Left ventricular systolic dysfunction	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Cardiac disorders Restrictive cardiomyopathy	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Cardiac disorders Supraven.arrhyth. Atrial flutter	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Cardiac disorders Ventric.arrhyth. Trigeminy	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Endocrine disorders Hypothyroidism	0.00% 0/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.03% 1/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Eye disorders Blurred vision	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Eye disorders Nyctalopia	0.00% 0/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.03% 1/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Eye disorders Ocular - Other	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Eye disorders Retinopathy	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
General disorders Fatigue	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Immune system disorders Allergic reaction	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Investigations Bilirubin	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Investigations Creatinine	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Investigations cTnI	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders CNS ischemia	0.08% 3/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.03% 1/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders Neurology - Other	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders Neuropathy-motor	0.00% 0/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.03% 1/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders Neuropathy: cranial CN VIII	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders Speech impairment	0.00% 0/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.03% 1/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders Syncope	0.00% 0/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.05% 2/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Psychiatric disorders Confusion	0.03% 1/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Renal and urinary disorders Incontinence, urinary	0.00% 0/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.03% 1/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Renal and urinary disorders Renal failure	0.05% 2/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.00% 0/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Vascular disorders Thrombosis/thrombus/embolism	0.08% 3/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	0.03% 1/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.

Measure	Exemestane n=3761 participants at risk Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally	Anastrozole n=3759 participants at risk Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
Gastrointestinal disorders Constipation	16.3% 614/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	16.1% 606/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Gastrointestinal disorders Diarrhea	12.3% 464/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	11.0% 414/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Gastrointestinal disorders Flatulence	10.6% 399/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	9.7% 363/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Gastrointestinal disorders Heartburn	15.3% 574/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	14.8% 556/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Gastrointestinal disorders Nausea	11.6% 436/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	11.8% 442/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Gastrointestinal disorders Pain Abdomen NOS	5.4% 202/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	5.9% 220/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
General disorders Edema: limb	19.9% 749/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	20.2% 760/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
General disorders Fatigue	45.1% 1697/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	46.5% 1749/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Injury, poisoning and procedural complications Fracture	7.7% 290/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	7.8% 292/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Investigations Cholesterol	15.7% 591/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	18.0% 677/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Investigations Weight gain	6.8% 257/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	7.6% 286/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Investigations Weight loss	6.1% 229/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	5.8% 218/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Metabolism and nutrition disorders Anorexia	6.3% 238/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	6.6% 249/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Metabolism and nutrition disorders Hyperglycemia	9.2% 347/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	9.9% 373/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Musculoskeletal and connective tissue disorders Arthritis	7.0% 264/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	6.4% 242/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Musculoskeletal and connective tissue disorders Osteoporosis	33.0% 1243/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	36.4% 1369/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Musculoskeletal and connective tissue disorders Pain Back	12.8% 480/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	13.4% 504/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Musculoskeletal and connective tissue disorders Pain Bone	10.1% 381/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	10.9% 410/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Musculoskeletal and connective tissue disorders Pain Extremity-limb	12.4% 468/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	13.6% 511/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Musculoskeletal and connective tissue disorders Pain Joint	55.4% 2085/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	55.5% 2086/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Musculoskeletal and connective tissue disorders Pain Muscle	17.7% 667/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	16.7% 629/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders Dizziness	14.0% 526/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	13.4% 504/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders Neuropathy-sensory	15.3% 576/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	14.0% 528/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Nervous system disorders Pain Head/headache	11.0% 414/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	10.6% 399/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Psychiatric disorders Insomnia	15.3% 574/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	13.9% 521/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Psychiatric disorders Mood alteration Anxiety	6.9% 258/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	6.1% 229/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Psychiatric disorders Mood alteration Depression	9.9% 374/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	10.0% 377/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Reproductive system and breast disorders Pain Breast	7.7% 288/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	8.3% 312/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Reproductive system and breast disorders Vaginal dryness	6.6% 248/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	6.9% 260/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Respiratory, thoracic and mediastinal disorders Cough	17.8% 671/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	17.7% 666/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	17.4% 656/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	17.3% 652/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Skin and subcutaneous tissue disorders Alopecia	6.2% 235/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	5.6% 212/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Skin and subcutaneous tissue disorders Rash	12.6% 474/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	11.6% 437/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Skin and subcutaneous tissue disorders Sweating	16.6% 626/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	16.0% 603/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Vascular disorders Hot flashes	55.5% 2086/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	56.9% 2138/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
Vascular disorders Hypertension	8.0% 300/3761 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.	8.7% 326/3759 • 8 years Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.