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

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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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Exemestane	Anastrozole
Arm/Group Description	Patients receive oral exemestane (2...	Patients receive oral anastrozole (...
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

Baseline Characteristics

Arm/Group Title		Exemestane	Anastrozole	Total
Arm/Group Description		Patients receive oral exemestane (2...	Patients receive oral anastrozole (...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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%

Outcome Measures

1.Primary Outcome


Title	Event-free Survival
Description	Event free survival, the primary endpoint of this study, is defined as...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Exemestane	Anastrozole
Arm/Group Description:	Patients receive oral exemestane (2...	Patients receive oral anastrozole (...
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)

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
Description	Overall survival is defined as the time from randomization to the time...
Description	Overall survival is defined as the time from randomization to the time of death from any cause.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

Intend to treat


Arm/Group Title	Exemestane	Anastrozole
Arm/Group Description:	Patients receive oral exemestane (2...	Patients receive oral anastrozole (...
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)

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
Description	Time to distant disease-free survival (DDFS) is defined as the time fr...
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

Outcome Measure Data

Analysis Population Description

Intent to treat


Arm/Group Title	Exemestane	Anastrozole
Arm/Group Description:	Patients receive oral exemestane (2...	Patients receive oral anastrozole (...
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.
Description	Clinical fracture at any time, including hip, spine, wrist fractures a...
Description	Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.
Time Frame	8 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Exemestane	Anastrozole
Arm/Group Description:	Patients receive oral exemestane (2...	Patients receive oral anastrozole (...
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%

Adverse Events

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
Arm/Group Description	Patients receive oral exemestane (2...	Patients receive oral anastrozole (...
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	--/--	--/--
Serious Adverse Events 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)
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)

Limitations and Caveats

[Not Specified]

More Information

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 of Results:

Moy B, Elliott CR, Chapman J-AW, et al.: NCIC CTG MA.27: menopausal symptoms of ethnic minority women. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3059, S144, 2006.

Goss PE, Ingle JN, Pritchard KI, Ellis MJ, Sledge GW, Budd GT, Rabaglio M, Ansari RH, Johnson DB, Tozer R, D'Souza DP, Chalchal H, Spadafora S, Stearns V, Perez EA, Liedke PE, Lang I, Elliott C, Gelmon KA, Chapman JA, Shepherd LE. Exemestane versus anastrozole in postmenopausal women with early breast cancer: NCIC CTG MA.27--a randomized controlled phase III trial. J Clin Oncol. 2013 Apr 10;31(11):1398-404. doi: 10.1200/JCO.2012.44.7805. Epub 2013 Jan 28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Strasser-Weippl K, Higgins MJ, Chapman JW, Ingle JN, Sledge GW, Budd GT, Ellis MJ, Pritchard KI, Clemons MJ, Badovinac-Crnjevic T, Han L, Gelmon KA, Rabaglio M, Elliott C, Shepherd LE, Goss PE. Effects of Celecoxib and Low-dose Aspirin on Outcomes in Adjuvant Aromatase Inhibitor-Treated Patients: CCTG MA.27. J Natl Cancer Inst. 2018 Sep 1;110(9):1003-1008. doi: 10.1093/jnci/djy017.

Strasser-Weippl K, Sudan G, Ramjeesingh R, Shepherd LE, O'Shaughnessy J, Parulekar WR, Liedke PER, Chen BE, Goss PE. Outcomes in women with invasive ductal or invasive lobular early stage breast cancer treated with anastrozole or exemestane in CCTG (NCIC CTG) MA.27. Eur J Cancer. 2018 Feb;90:19-25. doi: 10.1016/j.ejca.2017.11.014. Epub 2017 Dec 20.

Stearns V, Chapman JA, Ma CX, Ellis MJ, Ingle JN, Pritchard KI, Budd GT, Rabaglio M, Sledge GW, Le Maitre A, Kundapur J, Liedke PE, Shepherd LE, Goss PE. Treatment-associated musculoskeletal and vasomotor symptoms and relapse-free survival in the NCIC CTG MA.27 adjuvant breast cancer aromatase inhibitor trial. J Clin Oncol. 2015 Jan 20;33(3):265-71. doi: 10.1200/JCO.2014.57.6926. Epub 2014 Dec 15.

Goetz MP, Schaid DJ, Wickerham DL, Safgren S, Mushiroda T, Kubo M, Batzler A, Costantino JP, Vogel VG, Paik S, Carlson EE, Flockhart DA, Wolmark N, Nakamura Y, Weinshilboum RM, Ingle JN, Ames MM. Evaluation of CYP2D6 and efficacy of tamoxifen and raloxifene in women treated for breast cancer chemoprevention: results from the NSABP P1 and P2 clinical trials. Clin Cancer Res. 2011 Nov 1;17(21):6944-51. doi: 10.1158/1078-0432.CCR-11-0860. Epub 2011 Aug 31. Erratum in: Clin Cancer Res. 2012 Jun 15;18(12):3491.

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

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