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Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

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ClinicalTrials.gov Identifier: NCT00265759
Recruitment Status : Active, not recruiting
First Posted : December 15, 2005
Results First Posted : March 30, 2017
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: anastrozole
Drug: exemestane
Drug: letrozole
Procedure: Therapeutic Conventional Surgery
Enrollment 622
Recruitment Details Z1031A enrolled postmenopausal women with stage II/III ER+ (Allred 6 to 8) breast cancer (BC) whose treatment was randomized to neoadjuvant AI therapy with anastrozole, exemestane or letrozole. For Z1031B the protocol was amended to include a tumor Ki67 determination after 2-4 weeks of AI.
Pre-assignment Details  
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole Cohort B
Hide Arm/Group Description Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection. Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection. Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection. Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Period Title: Overall Study
Started 124 128 125 245
Completed 124 127 123 236
Not Completed 0 1 2 9
Reason Not Completed
Withdrawal by Subject             0             1             2             2
Cancel             0             0             0             3
Ineligible             0             0             0             1
Bilateral disease             0             0             0             2
Discontinued due to intolerability             0             0             0             1
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole Cohort B Arm I: Week 2 Ki67 <=10% Cohort B Arm II: Week 2 Ki67 >10% Cohort B Arm III: Week 2 Ki67 No Invasive Disease Present Total
Hide Arm/Group Description Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended. Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended. Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended. Total of all reporting groups
Overall Number of Baseline Participants 124 127 123 165 49 22 610
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 124 participants 127 participants 123 participants 165 participants 49 participants 22 participants 610 participants
69
(43 to 90)
65
(49 to 90)
65
(51 to 87)
65
(49 to 86)
60
(47 to 76)
66
(53 to 84)
65
(43 to 90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 127 participants 123 participants 165 participants 49 participants 22 participants 610 participants
Female
124
 100.0%
127
 100.0%
123
 100.0%
165
 100.0%
49
 100.0%
22
 100.0%
610
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 124 participants 127 participants 123 participants 165 participants 49 participants 22 participants 610 participants
124 127 123 165 49 22 610
1.Primary Outcome
Title Clinical Response (Complete or Partial Response) Rate (Cohort A)
Hide Description The clinical response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients randomized to that treatment. For each treatment arm, a 95% binomial confidence interval will be constructed for the true clinical response rate. Complete Response (CR): The disappearance of all known disease based on a comparison between the measurements at baseline and the Week 16 visit. Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) based on a comparison between the measurements at baseline and the Week 16 visit. In addition there can be no appearance of new lesions or progression of any lesion.
Time Frame Up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole
Hide Arm/Group Description:
Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Overall Number of Participants Analyzed 124 127 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
62.9
(53.8 to 71.4)
74.8
(66.3 to 82.1)
69.1
(60.1 to 77.1)
2.Primary Outcome
Title Anti-tumor Effect in Terms of Pathologic CR (pCR) Rate to Neoadjuvant Chemotherapy (Cohort B)
Hide Description The primary aim is to assess the anti-tumor effect in terms of pathologic CR rates of neo-adjuvant chemotherapy in patients with T2-T4c, any N, M0 breast cancer (by clinical staging) who are endocrine therapy resistant (that is, their Ki-67 level is >10 after 2-4 week of neo-adjuvant endocrine therapy alone). The pCR rate (percentage) for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.
Time Frame Up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed is a subset of the number of patients in Cohort B Arm II: Week 2 Ki67 >10% who switched to neoadjuvant chemotherapy. The remaining number of patients in this arm were not included in this analysis due to decision to either continue with AI therapy or undergo surgery directly.
Arm/Group Title Cohort B Arm II: Week 2 Ki67 > 10%
Hide Arm/Group Description:
Patients who after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy had a tumor Ki67 level of greater than 10% and switched to neoadjuvant chemotherapy.
Overall Number of Participants Analyzed 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
5.7
(0.7 to 19.1)
3.Secondary Outcome
Title Toxicity (Cohort A)
Hide Description Incidence of the most common grade 3+ toxicities reported to be probably, possibly, or definitely related to treatment as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (Cohort A) At each treatment evaluation, the type, severity, and attribution of each adverse event reported will be assessed using the NCI-CTCAE definitions. For each treatment, the percentage of patients who developed a severe (grade 3+) toxicity considered possibly, probably or definitively related to treatment will be determined.
Time Frame Up to 30 days after drug therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole
Hide Arm/Group Description:
Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Overall Number of Participants Analyzed 124 127 123
Measure Type: Number
Unit of Measure: percentage of patients
Fatigue 2 2 3
Hot flashes/flushes 2 4 2
Joint pain 2 3 2
4.Secondary Outcome
Title Progression-free Survival (PFS) (Cohort A and B)
Hide Description [Not Specified]
Time Frame assessed up to 10 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Rate of Improved Surgical Outcome for Patients Considered Marginal for Breast Conservation Surgery Prior to Therapy (Cohort A)
Hide Description The rate (percentage) of improved surgical outcome for patients considered marginal for breast conservation surgery prior to therapy for Cohort A is reported below for each treatment arm. Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.
Time Frame At time of surgery up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Overall Number of Participants Analyzed only includes patients considered marginal for breast conservation surgery prior to therapy.
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole
Hide Arm/Group Description:
Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Overall Number of Participants Analyzed 61 62 66
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of improved surgical outcome
85.2
(73.3 to 92.6)
77.4
(64.7 to 86.7)
86.4
(75.2 to 93.2)
6.Secondary Outcome
Title Rate of Downstaging to Stage I Determined by Sentinel Node Evaluation (Cohort A)
Hide Description The rate downstaging to Stage I of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgically findings are such that the maximum dimension of the invasive lesion contained in their surgical specimen is at most 2 cm and their lymph nodes are negative (by Hematoxylin & Eosin Staining) divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the rate of downstaging to Stage I between these 2 treatments.
Time Frame At time of surgery up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome Measure Data Not Collected.
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole
Hide Arm/Group Description:
Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Rate of Lymph Node Involvement (LNI) (Cohort A)
Hide Description For those patients who undergo a sentinel lymph node dissection or an axillary lymph node dissection (at least 6 nodes examined with Hematoxylin & Eosin Staining), the LNI rate (percentage) is defined as 100 times the proportion of eligible patients randomized to that treatment with at least one positive node. For each neo-adjuvant endocrine treatment, a 95% binomial confidence interval will be constructed for its true LNI rate.
Time Frame At time of surgery up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Overall Number of Participants Analyzed include only patients who were evaluated for the number of positive nodes and not evaluated before or during AI therapy.
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole
Hide Arm/Group Description:
Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Overall Number of Participants Analyzed 107 112 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
41.1
(31.8 to 51.1)
48.2
(38.7 to 57.8)
44.1
(34.8 to 53.9)
8.Secondary Outcome
Title The Pathologic Complete Response (pCR) Rate (Cohort A)
Hide Description The pathologic complete response is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes. The pathologic complete response rate (percentage) of a given treatment is defined as 100 times the number of eligible patients randomized to that treatment whose surgical specimen is such that there is no histologic evidence of invasive tumor cells in the surgical breast specimen and axillary or sentinel lymph nodes divided by the total number of eligible patients randomized to that treatment. For each neo-adjuvant endocrine treatment pair, a 95% binomial confidence interval will be constructed for the true difference in the pCR between these 2 treatments.
Time Frame At time of surgery up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Overall Number of Participants Analyzed only includes patients who had surgery performed after completion of AI therapy.
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole
Hide Arm/Group Description:
Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Overall Number of Participants Analyzed 115 120 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
1.7
(0.3 to 6.8)
0.0
(0.0 to 3.9)
0.0
(0.0 to 4.0)
9.Secondary Outcome
Title Clinical Response Rate (Cohort B)
Hide Description The clinical response rate is defined as 100 times the number of eligible patients whose disease meets the WHO criteria for complete or partial response prior to surgery divided by the total number of eligible patients. A 90% binomial confidence interval will be constructed for the true clinical response rate.
Time Frame Up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome Measure Data Not Collected.
Arm/Group Title Cohort B
Hide Arm/Group Description:
Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Rate of Improved Surgical Outcome for Patients Designated as Candidates for Mastectomy Prior to Therapy (Cohort A)
Hide Description Rate (percentage) of Improved surgical outcome for patients designated as candidates for mastectomy prior to therapy (Cohort A). Breast conservation surgery (not mastectomy) as the most extensive surgery performed for a patient is considered an improvement in surgical outcome.
Time Frame At time of surgery up to 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Overall Number of Participants Analyzed only includes patients considered candidates for mastectomy prior to therapy.
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole
Hide Arm/Group Description:
Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection
Overall Number of Participants Analyzed 52 57 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
48.1
(34.0 to 62.4)
42.1
(29.1 to 55.9)
60.0
(49.2 to 77.1)
11.Secondary Outcome
Title Overall Survival (Cohort A and B)
Hide Description Overall survival (OS) will be measured from the date of randomization until the date of death. The distribution of overall survival times will be estimated using the Kaplan-Meier method.
Time Frame assessed up to 10 years
Outcome Measure Data Not Reported
Time Frame Adverse events are assessed at the following time points: at W4, W8, W12, Within 1 week of W16, W16, and 30 days post drug therapy; Up to 10 years.
Adverse Event Reporting Description This study will collect adverse events using the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v.3.0). Note that effective April 1, 2011, CTCAE Version 4 has been used for expedited reporting via AdEERS. All graded adverse events are reported.
 
Arm/Group Title Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole Cohort B
Hide Arm/Group Description Patients receive oral exemestane 25 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection Patients receive oral letrozole 2.5 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection Patients receive oral anastrozole 1 mg once daily for up to 16-18 weeks prior to partial or radical mastectomy or lumpectomy with or without lymph node dissection Patients undergo a core breast biopsy for Ki67 determination after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy. If the Ki67 was ≤10% the patient continued AI therapy for another 12-14 weeks and then proceeded to surgery. Women whose two-week Ki67 level was > 10% were offered either a NCCN approved neoadjuvant chemotherapy regimen or surgery at the discretion of providers/patients. If the biopsy core contained insufficient tumor to perform the Ki67 assay patients could elect to be re-biopsied at 4 weeks or continue on AI therapy. If severe treatment-related toxicity was reported or the patient refused further AI therapy, surgery was recommended.
All-Cause Mortality
Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole Cohort B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole Cohort B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/157 (5.73%)      14/157 (8.92%)      12/155 (7.74%)      5/144 (3.47%)    
Blood and lymphatic system disorders         
Blood disorder  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Hemoglobin decreased  1  1/157 (0.64%)  1 2/157 (1.27%)  2 2/155 (1.29%)  3 0/144 (0.00%)  0
Hemolysis  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Cardiac disorders         
Arrhythmia  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Cardiac disorder  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Myocardial ischemia  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Ear and labyrinth disorders         
Hearing impaired  1  0/157 (0.00%)  0 2/157 (1.27%)  2 1/155 (0.65%)  1 0/144 (0.00%)  0
Tinnitus  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Eye disorders         
Cataract  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Diplopia  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Glaucoma  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Vision blurred  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Watering eyes  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Gastrointestinal disorders         
Abdominal distension  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Abdominal pain  1  0/157 (0.00%)  0 2/157 (1.27%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Constipation  1  0/157 (0.00%)  0 2/157 (1.27%)  2 1/155 (0.65%)  1 0/144 (0.00%)  0
Dental prosthesis user  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Diarrhea  1  1/157 (0.64%)  1 2/157 (1.27%)  2 1/155 (0.65%)  1 0/144 (0.00%)  0
Gastrointestinal disorder  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Nausea  1  4/157 (2.55%)  4 3/157 (1.91%)  3 2/155 (1.29%)  3 1/144 (0.69%)  1
Pancreatitis  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Rectal hemorrhage  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Vomiting  1  2/157 (1.27%)  2 2/157 (1.27%)  2 2/155 (1.29%)  3 0/144 (0.00%)  0
General disorders         
Edema limbs  1  0/157 (0.00%)  0 2/157 (1.27%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Fatigue  1  4/157 (2.55%)  4 10/157 (6.37%)  11 5/155 (3.23%)  7 1/144 (0.69%)  1
Fever  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
General symptom  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Pain  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 1/144 (0.69%)  1
Infections and infestations         
Pneumonia  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  1 0/144 (0.00%)  0
Skin infection  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 1/144 (0.69%)  1
Small intestine infection  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Urinary tract infection  1  1/157 (0.64%)  1 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Wound infection  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Injury, poisoning and procedural complications         
Bruising  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Fracture  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Postoperative hemorrhage  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  1 0/144 (0.00%)  0
Small intestinal anastomotic leak  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Wound dehiscence  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Investigations         
Alkaline phosphatase increased  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Amylase increased  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Leukocyte count decreased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Lipase increased  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Lymphocyte count decreased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Neutrophil count decreased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Metabolism and nutrition disorders         
Blood glucose increased  1  2/157 (1.27%)  2 0/157 (0.00%)  0 3/155 (1.94%)  4 0/144 (0.00%)  0
Dehydration  1  2/157 (1.27%)  2 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Glucose intolerance  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Serum albumin decreased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Serum glucose decreased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Serum potassium decreased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/157 (0.00%)  0 6/157 (3.82%)  7 3/155 (1.94%)  5 0/144 (0.00%)  0
Arthritis  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Back pain  1  0/157 (0.00%)  0 2/157 (1.27%)  2 3/155 (1.94%)  4 0/144 (0.00%)  0
Muscle weakness  1  1/157 (0.64%)  1 3/157 (1.91%)  3 2/155 (1.29%)  2 1/144 (0.69%)  1
Muscle weakness right-sided  1  0/157 (0.00%)  0 1/157 (0.64%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Myalgia  1  1/157 (0.64%)  1 2/157 (1.27%)  2 1/155 (0.65%)  1 0/144 (0.00%)  0
Osteoporosis  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Pain in extremity  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Nervous system disorders         
Dizziness  1  1/157 (0.64%)  1 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Headache  1  1/157 (0.64%)  1 0/157 (0.00%)  0 4/155 (2.58%)  4 0/144 (0.00%)  0
Ischemia cerebrovascular  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  2 0/144 (0.00%)  0
Memory impairment  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Neurological disorder NOS  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 2/144 (1.39%)  2
Peripheral sensory neuropathy  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Seizure  1  0/157 (0.00%)  0 1/157 (0.64%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Syncope  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Tremor  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Psychiatric disorders         
Agitation  1  0/157 (0.00%)  0 3/157 (1.91%)  3 0/155 (0.00%)  0 0/144 (0.00%)  0
Anxiety  1  0/157 (0.00%)  0 1/157 (0.64%)  1 4/155 (2.58%)  4 0/144 (0.00%)  0
Confusion  1  1/157 (0.64%)  1 1/157 (0.64%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Depression  1  1/157 (0.64%)  1 3/157 (1.91%)  3 2/155 (1.29%)  2 1/144 (0.69%)  1
Insomnia  1  2/157 (1.27%)  2 2/157 (1.27%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Psychosis  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Reproductive system and breast disorders         
Breast pain  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Vaginal dryness  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis  1  0/157 (0.00%)  0 2/157 (1.27%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Cough  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  1 0/144 (0.00%)  0
Dyspnea  1  2/157 (1.27%)  2 1/157 (0.64%)  1 5/155 (3.23%)  5 1/144 (0.69%)  1
Pleural effusion  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Pneumonitis  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Skin and subcutaneous tissue disorders         
Alopecia  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Dry skin  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Skin disorder  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  1 0/144 (0.00%)  0
Skin hypopigmentation  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Sweating  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Vascular disorders         
Hematoma  1  1/157 (0.64%)  1 3/157 (1.91%)  4 1/155 (0.65%)  2 1/144 (0.69%)  1
Hot flashes  1  1/157 (0.64%)  1 8/157 (5.10%)  8 3/155 (1.94%)  5 0/144 (0.00%)  0
Hypertension  1  3/157 (1.91%)  3 2/157 (1.27%)  2 1/155 (0.65%)  1 0/144 (0.00%)  0
Hypotension  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Thrombosis  1  1/157 (0.64%)  1 1/157 (0.64%)  1 0/155 (0.00%)  0 1/144 (0.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort A Arm I: Exemestane Cohort A Arm II: Letrozole Cohort A Arm III: Anastrozole Cohort B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   146/157 (92.99%)      146/157 (92.99%)      140/155 (90.32%)      123/144 (85.42%)    
Blood and lymphatic system disorders         
Blood disorder  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Febrile neutropenia  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Hemoglobin decreased  1  2/157 (1.27%)  2 2/157 (1.27%)  2 5/155 (3.23%)  9 0/144 (0.00%)  0
Lymphatic disorder  1  1/157 (0.64%)  1 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Cardiac disorders         
Arrhythmia  1  2/157 (1.27%)  2 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Atrial fibrillation  1  2/157 (1.27%)  5 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Atrial tachycardia  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Cardiac disorder  1  1/157 (0.64%)  1 0/157 (0.00%)  0 3/155 (1.94%)  6 0/144 (0.00%)  0
Cardiac pain  1  2/157 (1.27%)  2 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Left ventricular dysfunction  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Palpitations  1  0/157 (0.00%)  0 1/157 (0.64%)  1 5/155 (3.23%)  8 2/144 (1.39%)  6
Ear and labyrinth disorders         
Ear disorder  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Ear pain  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Hearing impaired  1  1/157 (0.64%)  6 3/157 (1.91%)  13 1/155 (0.65%)  2 0/144 (0.00%)  0
Hearing test abnormal  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  2 0/144 (0.00%)  0
Tinnitus  1  0/157 (0.00%)  0 2/157 (1.27%)  6 0/155 (0.00%)  0 0/144 (0.00%)  0
Endocrine disorders         
Endocrine disorder  1  1/157 (0.64%)  4 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Hypothyroidism  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  5 0/144 (0.00%)  0
Eye disorders         
Cataract  1  1/157 (0.64%)  5 1/157 (0.64%)  5 1/155 (0.65%)  2 0/144 (0.00%)  0
Dry eye syndrome  1  1/157 (0.64%)  3 2/157 (1.27%)  3 1/155 (0.65%)  1 0/144 (0.00%)  0
Eye disorder  1  1/157 (0.64%)  1 2/157 (1.27%)  2 3/155 (1.94%)  5 0/144 (0.00%)  0
Eye pain  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  3 0/144 (0.00%)  0
Eyelid function disorder  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Flashing vision  1  0/157 (0.00%)  0 1/157 (0.64%)  5 2/155 (1.29%)  3 0/144 (0.00%)  0
Glaucoma  1  0/157 (0.00%)  0 2/157 (1.27%)  6 1/155 (0.65%)  1 0/144 (0.00%)  0
Keratitis  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Photophobia  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Vision blurred  1  1/157 (0.64%)  4 4/157 (2.55%)  10 0/155 (0.00%)  0 0/144 (0.00%)  0
Vitreous hemorrhage  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Watering eyes  1  1/157 (0.64%)  2 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Gastrointestinal disorders         
Abdominal distension  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Abdominal pain  1  1/157 (0.64%)  1 2/157 (1.27%)  2 3/155 (1.94%)  4 2/144 (1.39%)  2
Anal pain  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Colitis  1  2/157 (1.27%)  2 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Constipation  1  14/157 (8.92%)  23 14/157 (8.92%)  24 12/155 (7.74%)  22 13/144 (9.03%)  19
Dental prosthesis user  1  1/157 (0.64%)  1 1/157 (0.64%)  4 0/155 (0.00%)  0 0/144 (0.00%)  0
Diarrhea  1  24/157 (15.29%)  40 11/157 (7.01%)  16 11/155 (7.10%)  16 5/144 (3.47%)  9
Dry mouth  1  3/157 (1.91%)  5 2/157 (1.27%)  6 0/155 (0.00%)  0 0/144 (0.00%)  0
Dyspepsia  1  3/157 (1.91%)  3 2/157 (1.27%)  2 2/155 (1.29%)  4 1/144 (0.69%)  6
Dysphagia  1  3/157 (1.91%)  3 2/157 (1.27%)  4 0/155 (0.00%)  0 0/144 (0.00%)  0
Ear, nose and throat examination abnormal  1  1/157 (0.64%)  1 0/157 (0.00%)  0 1/155 (0.65%)  4 1/144 (0.69%)  1
Esophagitis  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Flatulence  1  0/157 (0.00%)  0 1/157 (0.64%)  2 0/155 (0.00%)  0 1/144 (0.69%)  1
Gastritis  1  0/157 (0.00%)  0 1/157 (0.64%)  5 0/155 (0.00%)  0 0/144 (0.00%)  0
Gastrointestinal disorder  1  5/157 (3.18%)  5 1/157 (0.64%)  1 5/155 (3.23%)  9 2/144 (1.39%)  2
Hemorrhoids  1  1/157 (0.64%)  1 1/157 (0.64%)  1 1/155 (0.65%)  1 0/144 (0.00%)  0
Mucositis oral  1  2/157 (1.27%)  2 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Nausea  1  39/157 (24.84%)  59 41/157 (26.11%)  70 36/155 (23.23%)  57 23/144 (15.97%)  44
Oral hemorrhage  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Oral pain  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Periodontal disease  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Salivary gland disorder  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Stomach pain  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Tooth disorder  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  1 0/144 (0.00%)  0
Toothache  1  0/157 (0.00%)  0 1/157 (0.64%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Vomiting  1  12/157 (7.64%)  15 11/157 (7.01%)  21 12/155 (7.74%)  16 3/144 (2.08%)  3
General disorders         
Chest pain  1  2/157 (1.27%)  2 3/157 (1.91%)  3 1/155 (0.65%)  1 1/144 (0.69%)  1
Chills  1  2/157 (1.27%)  3 1/157 (0.64%)  3 1/155 (0.65%)  2 0/144 (0.00%)  0
Edema limbs  1  10/157 (6.37%)  20 8/157 (5.10%)  20 12/155 (7.74%)  19 6/144 (4.17%)  9
Fatigue  1  94/157 (59.87%)  280 88/157 (56.05%)  230 87/155 (56.13%)  230 76/144 (52.78%)  221
Fever  1  1/157 (0.64%)  1 3/157 (1.91%)  3 1/155 (0.65%)  1 0/144 (0.00%)  0
Flu-like symptoms  1  1/157 (0.64%)  1 1/157 (0.64%)  4 1/155 (0.65%)  1 0/144 (0.00%)  0
General symptom  1  2/157 (1.27%)  2 0/157 (0.00%)  0 3/155 (1.94%)  3 1/144 (0.69%)  1
Injection site reaction  1  1/157 (0.64%)  3 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Localized edema  1  2/157 (1.27%)  3 2/157 (1.27%)  3 2/155 (1.29%)  5 1/144 (0.69%)  1
Pain  1  6/157 (3.82%)  8 7/157 (4.46%)  13 11/155 (7.10%)  13 6/144 (4.17%)  8
Immune system disorders         
Autoimmune disorder  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Hypersensitivity  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Immune system disorder  1  2/157 (1.27%)  2 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Infections and infestations         
Bladder infection  1  0/157 (0.00%)  0 2/157 (1.27%)  2 1/155 (0.65%)  2 1/144 (0.69%)  1
Bronchitis  1  3/157 (1.91%)  4 2/157 (1.27%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Conjunctivitis infective  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Eye infection  1  2/157 (1.27%)  2 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Gingival infection  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  2
Infection  1  4/157 (2.55%)  4 3/157 (1.91%)  3 3/155 (1.94%)  3 1/144 (0.69%)  1
Lip infection  1  1/157 (0.64%)  2 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Nail infection  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Pharyngitis  1  0/157 (0.00%)  0 0/157 (0.00%)  0 2/155 (1.29%)  2 0/144 (0.00%)  0
Sinusitis  1  1/157 (0.64%)  1 3/157 (1.91%)  3 0/155 (0.00%)  0 1/144 (0.69%)  1
Skin infection  1  2/157 (1.27%)  2 1/157 (0.64%)  1 5/155 (3.23%)  6 4/144 (2.78%)  4
Tooth infection  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Upper respiratory infection  1  1/157 (0.64%)  2 2/157 (1.27%)  2 3/155 (1.94%)  3 1/144 (0.69%)  1
Urinary tract infection  1  3/157 (1.91%)  3 2/157 (1.27%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Vaginal infection  1  1/157 (0.64%)  1 2/157 (1.27%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Wound infection  1  5/157 (3.18%)  5 4/157 (2.55%)  4 2/155 (1.29%)  2 1/144 (0.69%)  1
Injury, poisoning and procedural complications         
Bruising  1  3/157 (1.91%)  5 2/157 (1.27%)  4 3/155 (1.94%)  3 1/144 (0.69%)  1
Fracture  1  3/157 (1.91%)  3 0/157 (0.00%)  0 4/155 (2.58%)  4 0/144 (0.00%)  0
Intraoperative musculoskeletal injury - Extremity-upper  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Intraoperative venous injury - Vein-jugular  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Seroma  1  3/157 (1.91%)  4 2/157 (1.27%)  3 2/155 (1.29%)  2 4/144 (2.78%)  4
Wound dehiscence  1  5/157 (3.18%)  6 1/157 (0.64%)  1 0/155 (0.00%)  0 3/144 (2.08%)  3
Investigations         
Alanine aminotransferase increased  1  1/157 (0.64%)  1 1/157 (0.64%)  1 2/155 (1.29%)  2 1/144 (0.69%)  1
Alkaline phosphatase increased  1  0/157 (0.00%)  0 2/157 (1.27%)  2 1/155 (0.65%)  1 0/144 (0.00%)  0
Aspartate aminotransferase increased  1  1/157 (0.64%)  1 1/157 (0.64%)  1 3/155 (1.94%)  5 1/144 (0.69%)  2
Blood bilirubin increased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  2 0/144 (0.00%)  0
Coagulopathy  1  2/157 (1.27%)  2 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Creatinine increased  1  1/157 (0.64%)  1 0/157 (0.00%)  0 3/155 (1.94%)  9 1/144 (0.69%)  1
Laboratory test abnormal  1  0/157 (0.00%)  0 0/157 (0.00%)  0 2/155 (1.29%)  6 1/144 (0.69%)  1
Leukocyte count decreased  1  0/157 (0.00%)  0 1/157 (0.64%)  1 2/155 (1.29%)  6 0/144 (0.00%)  0
Lymphocyte count decreased  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  1
Platelet count decreased  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  3 1/144 (0.69%)  1
Serum cholesterol increased  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  5 1/144 (0.69%)  1
Weight gain  1  3/157 (1.91%)  3 0/157 (0.00%)  0 2/155 (1.29%)  3 1/144 (0.69%)  1
Weight loss  1  1/157 (0.64%)  1 2/157 (1.27%)  3 1/155 (0.65%)  1 0/144 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia  1  6/157 (3.82%)  9 8/157 (5.10%)  16 5/155 (3.23%)  9 3/144 (2.08%)  4
Blood glucose increased  1  5/157 (3.18%)  8 4/157 (2.55%)  6 4/155 (2.58%)  6 1/144 (0.69%)  1
Dehydration  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Glucose intolerance  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 1/144 (0.69%)  3
Serum albumin decreased  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Serum calcium increased  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Serum glucose decreased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Serum potassium decreased  1  0/157 (0.00%)  0 1/157 (0.64%)  1 2/155 (1.29%)  2 2/144 (1.39%)  2
Serum sodium decreased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 2/155 (1.29%)  5 0/144 (0.00%)  0
Serum sodium increased  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  75/157 (47.77%)  218 75/157 (47.77%)  205 77/155 (49.68%)  189 57/144 (39.58%)  152
Arthritis  1  0/157 (0.00%)  0 2/157 (1.27%)  8 2/155 (1.29%)  5 1/144 (0.69%)  5
Back pain  1  39/157 (24.84%)  84 36/157 (22.93%)  97 40/155 (25.81%)  99 27/144 (18.75%)  63
Bone pain  1  1/157 (0.64%)  1 2/157 (1.27%)  3 1/155 (0.65%)  3 2/144 (1.39%)  3
Chest wall pain  1  3/157 (1.91%)  3 0/157 (0.00%)  0 2/155 (1.29%)  2 0/144 (0.00%)  0
Developmental disturbance  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Fibrosis  1  1/157 (0.64%)  6 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Joint disorder  1  2/157 (1.27%)  2 1/157 (0.64%)  1 3/155 (1.94%)  5 1/144 (0.69%)  1
Muscle weakness  1  25/157 (15.92%)  40 19/157 (12.10%)  51 28/155 (18.06%)  50 13/144 (9.03%)  34
Musculoskeletal disorder  1  2/157 (1.27%)  5 5/157 (3.18%)  5 2/155 (1.29%)  3 0/144 (0.00%)  0
Myalgia  1  38/157 (24.20%)  73 41/157 (26.11%)  83 41/155 (26.45%)  93 27/144 (18.75%)  58
Neck pain  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  5 1/144 (0.69%)  1
Osteoporosis  1  2/157 (1.27%)  2 0/157 (0.00%)  0 1/155 (0.65%)  4 0/144 (0.00%)  0
Pain in extremity  1  3/157 (1.91%)  6 7/157 (4.46%)  11 5/155 (3.23%)  9 3/144 (2.08%)  10
Trismus  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Upper extremity dysfunction  1  0/157 (0.00%)  0 0/157 (0.00%)  0 2/155 (1.29%)  2 0/144 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Treatment related secondary malignancy  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Nervous system disorders         
Ataxia  1  2/157 (1.27%)  2 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Depressed level of consciousness  1  1/157 (0.64%)  2 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  5
Dizziness  1  20/157 (12.74%)  28 17/157 (10.83%)  32 11/155 (7.10%)  19 7/144 (4.86%)  9
Dysgeusia  1  1/157 (0.64%)  1 0/157 (0.00%)  0 3/155 (1.94%)  5 1/144 (0.69%)  3
Extrapyramidal disorder  1  0/157 (0.00%)  0 0/157 (0.00%)  0 0/155 (0.00%)  0 1/144 (0.69%)  3
Glossopharyngeal nerve disorder  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Headache  1  29/157 (18.47%)  59 37/157 (23.57%)  75 37/155 (23.87%)  62 20/144 (13.89%)  38
Memory impairment  1  3/157 (1.91%)  4 7/157 (4.46%)  12 2/155 (1.29%)  7 0/144 (0.00%)  0
Mini mental status examination abnormal  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Neurological disorder NOS  1  0/157 (0.00%)  0 2/157 (1.27%)  3 2/155 (1.29%)  6 0/144 (0.00%)  0
Peripheral motor neuropathy  1  1/157 (0.64%)  3 0/157 (0.00%)  0 0/155 (0.00%)  0 2/144 (1.39%)  2
Peripheral sensory neuropathy  1  14/157 (8.92%)  30 9/157 (5.73%)  16 11/155 (7.10%)  16 8/144 (5.56%)  13
Sinus pain  1  2/157 (1.27%)  3 2/157 (1.27%)  2 1/155 (0.65%)  1 0/144 (0.00%)  0
Syncope  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  1 1/144 (0.69%)  1
Tremor  1  0/157 (0.00%)  0 1/157 (0.64%)  4 0/155 (0.00%)  0 0/144 (0.00%)  0
Psychiatric disorders         
Agitation  1  21/157 (13.38%)  38 19/157 (12.10%)  34 29/155 (18.71%)  51 11/144 (7.64%)  23
Anxiety  1  40/157 (25.48%)  77 42/157 (26.75%)  82 48/155 (30.97%)  96 29/144 (20.14%)  64
Confusion  1  1/157 (0.64%)  2 1/157 (0.64%)  1 3/155 (1.94%)  3 1/144 (0.69%)  1
Depression  1  32/157 (20.38%)  73 29/157 (18.47%)  64 32/155 (20.65%)  63 21/144 (14.58%)  37
Euphoria  1  2/157 (1.27%)  3 5/157 (3.18%)  12 6/155 (3.87%)  11 0/144 (0.00%)  0
Insomnia  1  18/157 (11.46%)  34 12/157 (7.64%)  21 12/155 (7.74%)  22 15/144 (10.42%)  40
Renal and urinary disorders         
Bladder pain  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Bladder spasm  1  0/157 (0.00%)  0 1/157 (0.64%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Cystitis  1  2/157 (1.27%)  2 3/157 (1.91%)  3 1/155 (0.65%)  1 0/144 (0.00%)  0
Renal failure  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Urinary frequency  1  4/157 (2.55%)  9 4/157 (2.55%)  4 1/155 (0.65%)  6 3/144 (2.08%)  3
Urinary incontinence  1  1/157 (0.64%)  1 3/157 (1.91%)  6 0/155 (0.00%)  0 0/144 (0.00%)  0
Urinary retention  1  1/157 (0.64%)  1 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Urine discoloration  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Urogenital disorder  1  2/157 (1.27%)  3 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Reproductive system and breast disorders         
Breast hypoplasia  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Breast pain  1  12/157 (7.64%)  19 13/157 (8.28%)  21 17/155 (10.97%)  27 14/144 (9.72%)  30
Pelvic pain  1  0/157 (0.00%)  0 0/157 (0.00%)  0 2/155 (1.29%)  5 1/144 (0.69%)  1
Reproductive tract disorder  1  1/157 (0.64%)  2 1/157 (0.64%)  2 1/155 (0.65%)  1 1/144 (0.69%)  1
Vaginal discharge  1  1/157 (0.64%)  1 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Vaginal dryness  1  2/157 (1.27%)  5 3/157 (1.91%)  4 3/155 (1.94%)  7 1/144 (0.69%)  5
Vaginal hemorrhage  1  0/157 (0.00%)  0 1/157 (0.64%)  1 2/155 (1.29%)  2 0/144 (0.00%)  0
Vaginal inflammation  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  1 0/144 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis  1  13/157 (8.28%)  14 4/157 (2.55%)  16 5/155 (3.23%)  13 0/144 (0.00%)  0
Cough  1  10/157 (6.37%)  12 14/157 (8.92%)  33 8/155 (5.16%)  18 6/144 (4.17%)  9
Dyspnea  1  21/157 (13.38%)  45 24/157 (15.29%)  52 20/155 (12.90%)  52 13/144 (9.03%)  34
Epistaxis  1  1/157 (0.64%)  1 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Laryngeal edema  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Laryngoscopy abnormal  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Nasal congestion  1  2/157 (1.27%)  3 1/157 (0.64%)  2 0/155 (0.00%)  0 0/144 (0.00%)  0
Pharyngolaryngeal pain  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Pleuritic pain  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Pneumonitis  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Pneumothorax  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Respiratory disorder  1  3/157 (1.91%)  3 4/157 (2.55%)  5 2/155 (1.29%)  2 1/144 (0.69%)  1
Voice alteration  1  1/157 (0.64%)  2 1/157 (0.64%)  1 1/155 (0.65%)  4 1/144 (0.69%)  2
Skin and subcutaneous tissue disorders         
Alopecia  1  8/157 (5.10%)  11 4/157 (2.55%)  8 5/155 (3.23%)  15 5/144 (3.47%)  13
Dry skin  1  1/157 (0.64%)  3 2/157 (1.27%)  5 2/155 (1.29%)  2 2/144 (1.39%)  2
Erythema multiforme  1  1/157 (0.64%)  1 1/157 (0.64%)  1 0/155 (0.00%)  0 0/144 (0.00%)  0
Hand-and-foot syndrome  1  0/157 (0.00%)  0 1/157 (0.64%)  1 1/155 (0.65%)  3 0/144 (0.00%)  0
Nail disorder  1  1/157 (0.64%)  1 0/157 (0.00%)  0 2/155 (1.29%)  5 0/144 (0.00%)  0
Photosensitivity  1  0/157 (0.00%)  0 1/157 (0.64%)  1 2/155 (1.29%)  2 0/144 (0.00%)  0
Pruritus  1  3/157 (1.91%)  4 4/157 (2.55%)  11 9/155 (5.81%)  19 2/144 (1.39%)  2
Rash acneiform  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 0/144 (0.00%)  0
Rash desquamating  1  5/157 (3.18%)  6 4/157 (2.55%)  5 3/155 (1.94%)  3 2/144 (1.39%)  2
Skin disorder  1  7/157 (4.46%)  10 3/157 (1.91%)  4 7/155 (4.52%)  10 1/144 (0.69%)  1
Skin hyperpigmentation  1  1/157 (0.64%)  1 0/157 (0.00%)  0 0/155 (0.00%)  0 0/144 (0.00%)  0
Sweating  1  7/157 (4.46%)  10 4/157 (2.55%)  4 4/155 (2.58%)  7 3/144 (2.08%)  8
Urticaria  1  0/157 (0.00%)  0 1/157 (0.64%)  1 0/155 (0.00%)  0 1/144 (0.69%)  2
Vascular disorders         
Flushing  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  5 1/144 (0.69%)  1
Hematoma  1  3/157 (1.91%)  3 4/157 (2.55%)  4 2/155 (1.29%)  2 1/144 (0.69%)  1
Hemorrhage  1  0/157 (0.00%)  0 0/157 (0.00%)  0 1/155 (0.65%)  1 1/144 (0.69%)  1
Hot flashes  1  77/157 (49.04%)  241 103/157 (65.61%)  330 86/155 (55.48%)  296 82/144 (56.94%)  277
Hypertension  1  6/157 (3.82%)  11 10/157 (6.37%)  24 14/155 (9.03%)  33 7/144 (4.86%)  17
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
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: Matthew J. Ellis, MB, BChir, BSc., PhD, FRCP
Organization: Baylor College of Medicine
Phone: 713 798-1999
EMail: Matthew.Ellis@bcm.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00265759     History of Changes
Obsolete Identifiers: NCT00698971
Other Study ID Numbers: ACOSOG-Z1031
ACOSOG-Z1031
CDR0000456382 ( Registry Identifier: NCI Physician Data Query )
First Submitted: December 14, 2005
First Posted: December 15, 2005
Results First Submitted: February 14, 2017
Results First Posted: March 30, 2017
Last Update Posted: July 9, 2019