ClinicalTrials.gov
ClinicalTrials.gov Menu

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (SOFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00066690
Recruitment Status : Active, not recruiting
First Posted : August 7, 2003
Results First Posted : September 22, 2016
Last Update Posted : September 22, 2016
Sponsor:
Collaborators:
Breast International Group
Cancer and Leukemia Group B
National Cancer Institute (NCI)
NSABP Foundation Inc
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Southwest Oncology Group
Information provided by (Responsible Party):
International Breast Cancer Study Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor Positive Breast Cancer
Progesterone Receptor Positive Tumor
Recurrent Breast Carcinoma
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Interventions Drug: Exemestane
Other: Laboratory Biomarker Analysis
Procedure: Oophorectomy
Other: Quality-of-Life Assessment
Radiation: Radiation Therapy
Drug: Tamoxifen
Drug: Triptorelin
Enrollment 3066

Recruitment Details 3066 patients were randomized between 17Dec03 and 27Jan11 at 426 centers in 25 countries.
Pre-assignment Details  
Arm/Group Title Tamoxifen T+OFS E+OFS
Hide Arm/Group Description Tamoxifen 20mg orally daily for 5 years Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Period Title: Overall Study
Started 1021 1024 1021
Completed 423 502 457
Not Completed 598 522 564
Reason Not Completed
Adverse Event             145             58             126
Death             3             0             2
Lack of Efficacy             114             110             76
Lost to Follow-up             40             21             29
Withdrawal by Subject             50             55             49
Treatment Ongoing             246             278             282
Arm/Group Title Tamoxifen T+OFS E+OFS Total
Hide Arm/Group Description Tamoxifen 20mg orally daily for 5 years Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Total of all reporting groups
Overall Number of Baseline Participants 1018 1015 1014 3047
Hide Baseline Analysis Population Description
Intention-to-treat population, excludes 19 patients who immediately withdrew consent.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 1018 participants 1015 participants 1014 participants 3047 participants
43
(38 to 46)
43
(38 to 47)
43
(38 to 47)
43
(38 to 47)
Gender   [1] 
Measure Type: Number
Unit of measure:  Percent of participants
Number Analyzed 1018 participants 1015 participants 1014 participants 3047 participants
Female 100 100 100 300
Male 0 0 0 0
[1]
Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Lymph-node status   [1] 
Measure Type: Number
Unit of measure:  Percent of participants
Number Analyzed 1018 participants 1015 participants 1014 participants 3047 participants
Negative 65.03 65.22 66.17 196.42
Positive 34.97 34.78 33.83 103.58
[1]
Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Tumor size   [1] 
Measure Type: Number
Unit of measure:  Percent of participants
Number Analyzed 1018 participants 1015 participants 1014 participants 3047 participants
Unknown 2.65 2.46 2.07 7.18
<=2 cm 66.40 64.63 66.86 197.89
>2cm 30.94 32.91 31.07 94.92
[1]
Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Tumor grade   [1] 
Measure Type: Number
Unit of measure:  Percent of participants
Number Analyzed 1018 participants 1015 participants 1014 participants 3047 participants
Unknown 2.36 2.36 2.17 6.89
1 27.01 26.11 24.36 77.48
2 48.33 50.64 53.65 152.62
3 22.30 20.89 19.82 63.01
[1]
Measure Description:

Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis.

Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.

HER2-status   [1] 
Measure Type: Number
Unit of measure:  Percent of participants
Number Analyzed 1018 participants 1015 participants 1014 participants 3047 participants
Unknown 4.32 2.86 2.66 9.84
Negative 84.18 85.42 84.52 254.12
Positive 11.49 11.72 12.82 36.03
[1]
Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
1.Primary Outcome
Title Disease-free Survival
Hide Description Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
Time Frame 5-year estimates, reported at a median follow-up of 67 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Tamoxifen T+OFS E+OFS
Hide Arm/Group Description:
Tamoxifen 20mg orally daily for 5 years
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed 1018 1015 1014
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.7
(82.2 to 86.9)
86.6
(84.2 to 88.7)
89
(86.8 to 90.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen, T+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.66 to 1.04
Estimation Comments Tamoxifen was the reference group in the estimation of the hazard ratio.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tamoxifen, E+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.53 to 0.86
Estimation Comments Tamoxifen was the reference group in the estimation of the hazard ratio.
2.Secondary Outcome
Title Breast Cancer-free Interval
Hide Description Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Time Frame 5-year estimates, reported at a median follow-up of 67 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Tamoxifen T+OFS E+OFS
Hide Arm/Group Description:
Tamoxifen 20mg orally daily for 5 years
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed 1018 1015 1014
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.4
(84.0 to 88.5)
88.4
(86.1 to 90.3)
90.9
(88.9 to 92.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen, T+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.3 to 1.03
Estimation Comments Tamoxifen was the reference group in the estimation of the hazard ratio.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tamoxifen, E+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.49 to 0.83
Estimation Comments Tamoxifen was the reference group in the estimation of the hazard ratio.
3.Secondary Outcome
Title Distant Recurrence-free Interval
Hide Description Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Time Frame 5-year estimates, reported at a median follow-up of 67 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Tamoxifen T+OFS E+OFS
Hide Arm/Group Description:
Tamoxifen 20mg orally daily for 5 years
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed 1018 1015 1014
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.7
(88.6 to 92.4)
91.3
(89.2 to 92.9)
93.0
(91.2 to 94.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen, T+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.66 to 1.18
Estimation Comments T was the reference group in the estimation of the hazard ratio.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tamoxifen, E+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.52 to 0.96
Estimation Comments T was the reference group in the estimation of hazard ratio.
4.Secondary Outcome
Title Overall Survival
Hide Description Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Time Frame 5-year estimates
Outcome Measure Data Not Reported
Time Frame Assessed every 3 months for the first year, then every 6 month until year 6. Reported at a median follow-up of 67 months.
Adverse Event Reporting Description Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.
 
Arm/Group Title Tamoxifen T+OFS E+OFS
Hide Arm/Group Description Tamoxifen 20mg orally daily for 5 years Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
All-Cause Mortality
Tamoxifen T+OFS E+OFS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tamoxifen T+OFS E+OFS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   315/1007 (31.28%)   375/1007 (37.24%)   375/1001 (37.46%) 
Blood and lymphatic system disorders       
Hemoglobin  1  2/1007 (0.20%)  2/1007 (0.20%)  2/1001 (0.20%) 
Cardiac disorders       
Cardiac Arrhythmia-Other (Specify)  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Cardiac-ischemia/infarction  1  4/1007 (0.40%)  1/1007 (0.10%)  3/1001 (0.30%) 
Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Conduction abnormality/Atrioventricular heart block - Sick sinus syndrome  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Left ventricular diastolic dysfunction  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Left ventricular systolic dysfunction  1  0/1007 (0.00%)  2/1007 (0.20%)  3/1001 (0.30%) 
Pain - Cardiac/heart  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Restrictive cardiomyopathy  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Right ventricular dysfunction (cor pulmonale)  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Supraventricular and nodal arrhythmia - Atrial fibrillation  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Supraventricular and nodal arrhythmia - Sinus arrhythmia  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Supraventricular and nodal arrhythmia - Supraventricular tachycardia  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Valvular heart disease  1  2/1007 (0.20%)  0/1007 (0.00%)  0/1001 (0.00%) 
Ear and labyrinth disorders       
Auditory/Ear-Other (Specify)  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Hearing: patients without baseline audiogram and not enrolled in a monitoring program  1  1/1007 (0.10%)  0/1007 (0.00%)  1/1001 (0.10%) 
Endocrine disorders       
Thyroid function, high (hyperthyroidism, thyrotoxicosis)  1  0/1007 (0.00%)  1/1007 (0.10%)  1/1001 (0.10%) 
Thyroid function, low (hypothyroidism)  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Adrenal insufficiency  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Endocrine-Other (Specify)  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Eye disorders       
Cataract  1  1/1007 (0.10%)  0/1007 (0.00%)  1/1001 (0.10%) 
Ocular/Visual-Other (Specify)  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Optic disc edema  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Retinal detachment  1  3/1007 (0.30%)  1/1007 (0.10%)  1/1001 (0.10%) 
Vision-flashing lights/floaters  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Gastrointestinal disorders       
Distention/bloating, abdominal  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Necrosis, GI - Ileum  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Obstruction, GI - Small bowel NOS  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Stricture/stenosis (including anastomotic), GI - Small bowel NOS  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Ulcer, GI - Anus  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Colitis  1  2/1007 (0.20%)  1/1007 (0.10%)  1/1001 (0.10%) 
Constipation  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Diarrhea  1  1/1007 (0.10%)  2/1007 (0.20%)  1/1001 (0.10%) 
Dysphagia (difficulty swallowing)  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Gastrointestinal-Other (Specify)  1  2/1007 (0.20%)  1/1007 (0.10%)  2/1001 (0.20%) 
Heartburn/dyspepsia  1  0/1007 (0.00%)  1/1007 (0.10%)  1/1001 (0.10%) 
Hemorrhoids  1  0/1007 (0.00%)  1/1007 (0.10%)  1/1001 (0.10%) 
Mucositis/stomatitis (functional/symptomatic) - Oral cavity  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Nausea  1  0/1007 (0.00%)  4/1007 (0.40%)  2/1001 (0.20%) 
Pain - Abdomen NOS  1  3/1007 (0.30%)  3/1007 (0.30%)  4/1001 (0.40%) 
Pain - Rectum  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Pancreatitis  1  0/1007 (0.00%)  1/1007 (0.10%)  1/1001 (0.10%) 
Vomiting  1  0/1007 (0.00%)  1/1007 (0.10%)  1/1001 (0.10%) 
General disorders       
Fatigue (asthenia, lethargy, malaise)  1  32/1007 (3.18%)  36/1007 (3.57%)  33/1001 (3.30%) 
Death not associated with CTCAE term - Death NOS  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Death not associated with CTCAE term - Sudden death  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Edema: limb  1  2/1007 (0.20%)  0/1007 (0.00%)  0/1001 (0.00%) 
Flu-like syndrome  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Injection site reaction/extravasation changes  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Pain - Chest/thorax NOS  1  2/1007 (0.20%)  1/1007 (0.10%)  2/1001 (0.20%) 
Pain-Other (Specify)  1  1/1007 (0.10%)  0/1007 (0.00%)  1/1001 (0.10%) 
Hepatobiliary disorders       
Cholecystitis  1  2/1007 (0.20%)  2/1007 (0.20%)  2/1001 (0.20%) 
Hepatobiliary/Pancreas-Other (Specify)  1  3/1007 (0.30%)  2/1007 (0.20%)  4/1001 (0.40%) 
Liver dysfunction/failure (clinical)  1  1/1007 (0.10%)  5/1007 (0.50%)  1/1001 (0.10%) 
Pain - Gallbladder  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Immune system disorders       
Allergic reaction/hypersensitivity (including drug fever)  1  1/1007 (0.10%)  2/1007 (0.20%)  6/1001 (0.60%) 
Allergy/Immunology-Other (Specify)  1  0/1007 (0.00%)  2/1007 (0.20%)  0/1001 (0.00%) 
Infections and infestations       
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant)  1  1/1007 (0.10%)  2/1007 (0.20%)  1/1001 (0.10%) 
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Skin (cellulitis)  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Urinary tract NOS  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Infection (documented clinically/microbiologically) w/Grade 3/4 neutrophils -Gallbladder  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix  1  1/1007 (0.10%)  2/1007 (0.20%)  1/1001 (0.10%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)  1  1/1007 (0.10%)  1/1007 (0.10%)  1/1001 (0.10%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney  1  0/1007 (0.00%)  1/1007 (0.10%)  1/1001 (0.10%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)  1  2/1007 (0.20%)  3/1007 (0.30%)  0/1001 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)  1  4/1007 (0.40%)  10/1007 (0.99%)  12/1001 (1.20%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS  1  0/1007 (0.00%)  1/1007 (0.10%)  2/1001 (0.20%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Wound  1  3/1007 (0.30%)  3/1007 (0.30%)  1/1001 (0.10%) 
Infection with unknown ANC - Heart (endocarditis)  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Infection with unknown ANC - Rectum  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Infection with unknown ANC - Skin (cellulitis)  1  3/1007 (0.30%)  2/1007 (0.20%)  1/1001 (0.10%) 
Infection with unknown ANC - Wound  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Infection-Other (Specify)  1  0/1007 (0.00%)  1/1007 (0.10%)  2/1001 (0.20%) 
Injury, poisoning and procedural complications       
Hemorrhage/bleeding associated with surgery, intra-operative or post-operative  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Wound complication, non-infectious  1  0/1007 (0.00%)  1/1007 (0.10%)  1/1001 (0.10%) 
Fracture  1  8/1007 (0.79%)  8/1007 (0.79%)  12/1001 (1.20%) 
Intra-operative injury - Vein NOS  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Rash: dermatitis associated with radiation - Radiation  1  2/1007 (0.20%)  0/1007 (0.00%)  1/1001 (0.10%) 
Thrombosis/embolism (vascular access-related)  1  17/1007 (1.69%)  17/1007 (1.69%)  7/1001 (0.70%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/1007 (0.10%)  3/1007 (0.30%)  2/1001 (0.20%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  1/1007 (0.10%)  1/1007 (0.10%)  0/1001 (0.00%) 
Creatinine  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
GGT (gamma-glutamyl transpeptidase)  1  2/1007 (0.20%)  3/1007 (0.30%)  5/1001 (0.50%) 
Leukocytes (total WBC)  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Weight loss  1  0/1007 (0.00%)  2/1007 (0.20%)  2/1001 (0.20%) 
Metabolism and nutrition disorders       
Glucose, serum-high (hyperglycemia)  1  1/1007 (0.10%)  9/1007 (0.89%)  5/1001 (0.50%) 
Potassium, serum-low (hypokalemia)  1  2/1007 (0.20%)  2/1007 (0.20%)  0/1001 (0.00%) 
Iron overload  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Pancreatic endocrine: glucose intolerance  1  3/1007 (0.30%)  14/1007 (1.39%)  3/1001 (0.30%) 
Musculoskeletal and connective tissue disorders       
Arthritis (non-septic)  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Lumbar spine-range of motion  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Musculoskeletal/Soft Tissue-Other (Specify)  1  2/1007 (0.20%)  1/1007 (0.10%)  3/1001 (0.30%) 
Myositis (inflammation/damage of muscle)  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Osteoporosis  1  1/1007 (0.10%)  3/1007 (0.30%)  2/1001 (0.20%) 
Pain - Back  1  1/1007 (0.10%)  1/1007 (0.10%)  1/1001 (0.10%) 
Pain - Chest wall  1  1/1007 (0.10%)  0/1007 (0.00%)  1/1001 (0.10%) 
Pain - Extremity-limb  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Pain - Joint  1  64/1007 (6.36%)  55/1007 (5.46%)  119/1001 (11.89%) 
Pain - Muscle  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Nervous system disorders       
Hemorrhage, CNS  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
CNS cerebrovascular ischemia  1  4/1007 (0.40%)  1/1007 (0.10%)  3/1001 (0.30%) 
Cognitive disturbance  1  1/1007 (0.10%)  1/1007 (0.10%)  1/1001 (0.10%) 
Dizziness  1  3/1007 (0.30%)  0/1007 (0.00%)  5/1001 (0.50%) 
Memory impairment  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Myelitis  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Neurology-Other (Specify)  1  2/1007 (0.20%)  1/1007 (0.10%)  2/1001 (0.20%) 
Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Neuropathy: cranial - CN VIII Hearing and balance  1  0/1007 (0.00%)  1/1007 (0.10%)  1/1001 (0.10%) 
Neuropathy: sensory  1  1/1007 (0.10%)  5/1007 (0.50%)  4/1001 (0.40%) 
Pain - Head/headache  1  6/1007 (0.60%)  10/1007 (0.99%)  10/1001 (1.00%) 
Pain - Neuralgia/peripheral nerve  1  0/1007 (0.00%)  2/1007 (0.20%)  6/1001 (0.60%) 
Syncope (fainting)  1  1/1007 (0.10%)  2/1007 (0.20%)  4/1001 (0.40%) 
Vasovagal episode  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Psychiatric disorders       
Insomnia  1  29/1007 (2.88%)  46/1007 (4.57%)  45/1001 (4.50%) 
Mood alteration - anxiety  1  2/1007 (0.20%)  2/1007 (0.20%)  1/1001 (0.10%) 
Mood alteration - depression  1  38/1007 (3.77%)  44/1007 (4.37%)  37/1001 (3.70%) 
Psychosis (hallucinations/delusions)  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Renal and urinary disorders       
Incontinence, urinary  1  6/1007 (0.60%)  5/1007 (0.50%)  4/1001 (0.40%) 
Obstruction, GU - Ureter  1  0/1007 (0.00%)  1/1007 (0.10%)  4/1001 (0.40%) 
Stricture/stenosis (including anastomotic), GU - Ureter  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Renal failure  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Renal/Genitourinary-Other (Specify)  1  49/1007 (4.87%)  19/1007 (1.89%)  11/1001 (1.10%) 
Reproductive system and breast disorders       
Hemorrhage, GU - Ovary  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Hemorrhage, GU - Uterus  1  5/1007 (0.50%)  1/1007 (0.10%)  3/1001 (0.30%) 
Hemorrhage, GU - Vagina  1  5/1007 (0.50%)  1/1007 (0.10%)  1/1001 (0.10%) 
Stricture/stenosis (including anastomotic), GU - Uterus  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Irregular menses (change from baseline)  1  4/1007 (0.40%)  2/1007 (0.20%)  0/1001 (0.00%) 
Pain - Breast  1  2/1007 (0.20%)  0/1007 (0.00%)  1/1001 (0.10%) 
Pain - Ovulatory  1  1/1007 (0.10%)  1/1007 (0.10%)  0/1001 (0.00%) 
Pain - Pelvis  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Pain - Vagina  1  14/1007 (1.39%)  22/1007 (2.18%)  19/1001 (1.90%) 
Sexual/Reproductive Function-Other (Specify)  1  0/1007 (0.00%)  2/1007 (0.20%)  2/1001 (0.20%) 
Respiratory, thoracic and mediastinal disorders       
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Apnea  1  1/1007 (0.10%)  0/1007 (0.00%)  2/1001 (0.20%) 
Dyspnea (shortness of breath)  1  2/1007 (0.20%)  2/1007 (0.20%)  2/1001 (0.20%) 
Hypoxia  1  1/1007 (0.10%)  1/1007 (0.10%)  0/1001 (0.00%) 
Obstruction/stenosis of airway - Bronchus  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Pain - Pleura  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Pleural effusion (non-malignant)  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)  1  0/1007 (0.00%)  0/1007 (0.00%)  1/1001 (0.10%) 
Dermatology/Skin-Other (Specify)  1  2/1007 (0.20%)  1/1007 (0.10%)  0/1001 (0.00%) 
Pain - Skin  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Pruritus/itching  1  0/1007 (0.00%)  3/1007 (0.30%)  0/1001 (0.00%) 
Soft tissue necrosis - Thorax  1  0/1007 (0.00%)  1/1007 (0.10%)  0/1001 (0.00%) 
Vascular disorders       
Hematoma  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Hot flashes/flushes  1  76/1007 (7.55%)  133/1007 (13.21%)  107/1001 (10.69%) 
Hypertension  1  54/1007 (5.36%)  75/1007 (7.45%)  68/1001 (6.79%) 
Thrombosis/thrombus/embolism  1  0/1007 (0.00%)  2/1007 (0.20%)  0/1001 (0.00%) 
Vascular-Other (Specify)  1  1/1007 (0.10%)  0/1007 (0.00%)  0/1001 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tamoxifen T+OFS E+OFS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   951/1007 (94.44%)   982/1007 (97.52%)   980/1001 (97.90%) 
Cardiac disorders       
Cardiac-ischemia/infarction  1  1/1007 (0.10%)  2/1007 (0.20%)  5/1001 (0.50%) 
Gastrointestinal disorders       
Nausea  1  239/1007 (23.73%)  215/1007 (21.35%)  228/1001 (22.78%) 
General disorders       
Fatigue (asthenia, lethargy, malaise)  1  571/1007 (56.70%)  595/1007 (59.09%)  591/1001 (59.04%) 
Injection site reaction/extravasation changes  1  4/1007 (0.40%)  88/1007 (8.74%)  84/1001 (8.39%) 
Immune system disorders       
Allergic reaction/hypersensitivity (including drug fever)  1  31/1007 (3.08%)  42/1007 (4.17%)  46/1001 (4.60%) 
Injury, poisoning and procedural complications       
Fracture  1  41/1007 (4.07%)  46/1007 (4.57%)  51/1001 (5.09%) 
Thrombosis/embolism (vascular access-related)  1  5/1007 (0.50%)  3/1007 (0.30%)  2/1001 (0.20%) 
Metabolism and nutrition disorders       
Glucose, serum-high (hyperglycemia)  1  15/1007 (1.49%)  37/1007 (3.67%)  17/1001 (1.70%) 
Pancreatic endocrine: glucose intolerance  1  15/1007 (1.49%)  21/1007 (2.09%)  28/1001 (2.80%) 
Musculoskeletal and connective tissue disorders       
Osteoporosis  1  123/1007 (12.21%)  198/1007 (19.66%)  316/1001 (31.57%) 
Pain - Joint  1  631/1007 (62.66%)  700/1007 (69.51%)  778/1001 (77.72%) 
Nervous system disorders       
Hemorrhage, CNS  1  14/1007 (1.39%)  9/1007 (0.89%)  8/1001 (0.80%) 
CNS cerebrovascular ischemia  1  2/1007 (0.20%)  1/1007 (0.10%)  0/1001 (0.00%) 
Psychiatric disorders       
Insomnia  1  437/1007 (43.40%)  529/1007 (52.53%)  549/1001 (54.85%) 
Libido  1  427/1007 (42.40%)  477/1007 (47.37%)  492/1001 (49.15%) 
Mood alteration - depression  1  431/1007 (42.80%)  478/1007 (47.47%)  476/1001 (47.55%) 
Renal and urinary disorders       
Incontinence, urinary  1  156/1007 (15.49%)  180/1007 (17.87%)  120/1001 (11.99%) 
Reproductive system and breast disorders       
Pain - Vagina  1  224/1007 (22.24%)  240/1007 (23.83%)  290/1001 (28.97%) 
Vaginal dryness  1  421/1007 (41.81%)  500/1007 (49.65%)  541/1001 (54.05%) 
Skin and subcutaneous tissue disorders       
Sweating (diaphoresis)  1  486/1007 (48.26%)  621/1007 (61.67%)  566/1001 (56.54%) 
Vascular disorders       
Hot flashes/flushes  1  727/1007 (72.19%)  806/1007 (80.04%)  820/1001 (81.92%) 
Hypertension  1  119/1007 (11.82%)  158/1007 (15.69%)  165/1001 (16.48%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Rudolf Maibach, Executive Officer for International Trial Activities
Organization: IBCSG
Phone: +41 31 389 91 96
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00066690     History of Changes
Obsolete Identifiers: NCT00917969, NCT02140190
Other Study ID Numbers: IBCSG 24-02
NCI-2009-01086 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000316456
BIG 2-02
2004-000166-13
IBCSG-24-02 ( Other Identifier: CTEP )
N02CM62212 ( U.S. NIH Grant/Contract )
U24CA075362 ( U.S. NIH Grant/Contract )
First Submitted: August 6, 2003
First Posted: August 7, 2003
Results First Submitted: July 14, 2015
Results First Posted: September 22, 2016
Last Update Posted: September 22, 2016