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Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)

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ClinicalTrials.gov Identifier: NCT00066703
Recruitment Status : Active, not recruiting
First Posted : August 7, 2003
Results First Posted : April 5, 2016
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Breast International 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
Condition Breast Cancer
Interventions Drug: exemestane
Drug: tamoxifen
Drug: triptorelin
Enrollment 2672
Recruitment Details 2672 patients were randomized between 7Nov03 and 7Apr11 at 182 centers in 15 countries.
Pre-assignment Details  
Arm/Group Title T+OFS E+OFS
Hide Arm/Group Description Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Period Title: Overall Study
Started 1334 1338
Completed 722 756
Not Completed 612 582
Reason Not Completed
Adverse Event             80             111
Death             3             0
Lack of Efficacy             114             69
Lost to Follow-up             31             28
Withdrawal by Subject             38             63
Treatment ongoing             346             311
Arm/Group Title T+OFS E+OFS Total
Hide Arm/Group Description Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. Total of all reporting groups
Overall Number of Baseline Participants 1328 1332 2660
Hide Baseline Analysis Population Description
Intention-to-treat population excludes 12 patients who immediately withdrew consent, were at a non-adherent center, or had inadequate documentation of informed consent.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Age Number Analyzed 1328 participants 1332 participants 2660 participants
44
(40 to 46)
43
(39 to 46)
43
(40 to 46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1328 participants 1332 participants 2660 participants
Female
1328
 100.0%
1332
 100.0%
2660
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Lymph-node status   [1] 
Measure Type: Number
Unit of measure:  Percent of participants
Number Analyzed 1328 participants 1332 participants 2660 participants
Negative 52 52 104
Positive 48 48 96
[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 1328 participants 1332 participants 2660 participants
<=2 cm 60 59 119
>=2 cm 39 40 79
unknown 1 1 2
[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 1328 participants 1332 participants 2660 participants
1 17 17 34
2 56 55 111
3 26 27 53
unknown 1 1 2
[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 1328 participants 1332 participants 2660 participants
Negative 87 87 174
Positive 12 12 24
Unknown 1 1 2
[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 estimate reported at a median follow-up of 72 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title T+OFS E+OFS
Hide Arm/Group Description:
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Overall Number of Participants Analyzed 1328 1332
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.3
(85.7 to 88.7)
91.1
(89.7 to 92.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+OFS, E+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.717
Confidence Interval (2-Sided) 95%
0.602 to 0.855
Estimation Comments T+OFS is 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 the 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 estimate reported at a median follow-up of 72 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title T+OFS E+OFS
Hide Arm/Group Description:
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Overall Number of Participants Analyzed 1328 1332
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.8
(87.3 to 90.1)
92.8
(91.6 to 93.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+OFS, E+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.664
Confidence Interval (2-Sided) 95%
.548 to .804
Estimation Comments T+OFS is the reference group for 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 breast cancer recurrence at a distant site; or censored at date of last follow-up
Time Frame 5-year estimates reported at a median follow-up of 72 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title T+OFS E+OFS
Hide Arm/Group Description:
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Overall Number of Participants Analyzed 1328 1332
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
92.0
(90.7 to 93.1)
93.8
(92.7 to 94.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T+OFS, E+OFS
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.777
Confidence Interval (2-Sided) 95%
0.624 to 0.967
Estimation Comments T+OFS was the reference group in the estimation of the 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 months until year 6. Reported at a median follow-up of 72 months.
Adverse Event Reporting Description Targeted adverse events and other grade 3 or higher adverse events were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.
 
Arm/Group Title T+OFS E+OFS
Hide Arm/Group Description Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
All-Cause Mortality
T+OFS E+OFS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T+OFS E+OFS
Affected / at Risk (%) Affected / at Risk (%)
Total   484/1321 (36.64%)   496/1317 (37.66%) 
Blood and lymphatic system disorders     
Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)  1  1/1321 (0.08%)  0/1317 (0.00%) 
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura or hemolytic uremic syndrome)  1  1/1321 (0.08%)  0/1317 (0.00%) 
Blood/Bone Marrow-Other (Specify)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Febrile neutropenia  1  1/1321 (0.08%)  1/1317 (0.08%) 
Hemoglobin  1  3/1321 (0.23%)  2/1317 (0.15%) 
Cardiac disorders     
Cardiac Arrhythmia-Other (Specify)  1  1/1321 (0.08%)  0/1317 (0.00%) 
Cardiac-ischemia/infarction  1  2/1321 (0.15%)  4/1317 (0.30%) 
Left ventricular diastolic dysfunction  1  0/1321 (0.00%)  1/1317 (0.08%) 
Left ventricular systolic dysfunction  1  3/1321 (0.23%)  1/1317 (0.08%) 
Pain - Cardiac/heart  1  0/1321 (0.00%)  1/1317 (0.08%) 
Supraventricular and nodal arrhythmia - Atrial fibrillation  1  2/1321 (0.15%)  2/1317 (0.15%) 
Supraventricular and nodal arrhythmia - Sinus tachycardia  1  2/1321 (0.15%)  0/1317 (0.00%) 
Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS  1  1/1321 (0.08%)  0/1317 (0.00%) 
Supraventricular and nodal arrhythmia - Supraventricular tachycardia  1  0/1321 (0.00%)  1/1317 (0.08%) 
Valvular heart disease  1  0/1321 (0.00%)  1/1317 (0.08%) 
Ear and labyrinth disorders     
Auditory/Ear-Other (Specify)  1  1/1321 (0.08%)  1/1317 (0.08%) 
Endocrine disorders     
Thyroid function, high (hyperthyroidism, thyrotoxicosis)  1  2/1321 (0.15%)  0/1317 (0.00%) 
Thyroid function, low (hypothyroidism)  1  1/1321 (0.08%)  1/1317 (0.08%) 
Endocrine-Other (Specify)  1  1/1321 (0.08%)  1/1317 (0.08%) 
Eye disorders     
Cataract  1  1/1321 (0.08%)  1/1317 (0.08%) 
Retinal detachment  1  1/1321 (0.08%)  1/1317 (0.08%) 
Retinopathy  1  1/1321 (0.08%)  0/1317 (0.00%) 
Gastrointestinal disorders     
Hemorrhage, GI - Rectum  1  1/1321 (0.08%)  1/1317 (0.08%) 
Hemorrhage, GI - Varices (rectal)  1  1/1321 (0.08%)  0/1317 (0.00%) 
Obstruction, GI - Small bowel NOS  1  0/1321 (0.00%)  1/1317 (0.08%) 
Perforation, GI - Duodenum  1  1/1321 (0.08%)  0/1317 (0.00%) 
Stricture/stenosis (including anastomotic), GI - Esophagus  1  1/1321 (0.08%)  0/1317 (0.00%) 
Ulcer, GI - Stomach  1  0/1321 (0.00%)  1/1317 (0.08%) 
Colitis  1  1/1321 (0.08%)  0/1317 (0.00%) 
Constipation  1  2/1321 (0.15%)  0/1317 (0.00%) 
Diarrhea  1  3/1321 (0.23%)  1/1317 (0.08%) 
Gastritis (including bile reflux gastritis)  1  0/1321 (0.00%)  2/1317 (0.15%) 
Gastrointestinal-Other (Specify)  1  1/1321 (0.08%)  3/1317 (0.23%) 
Hemorrhoids  1  2/1321 (0.15%)  0/1317 (0.00%) 
Nausea  1  9/1321 (0.68%)  15/1317 (1.14%) 
Pain - Abdomen NOS  1  5/1321 (0.38%)  3/1317 (0.23%) 
Pain - Stomach  1  0/1321 (0.00%)  2/1317 (0.15%) 
Pancreatitis  1  1/1321 (0.08%)  0/1317 (0.00%) 
Vomiting  1  1/1321 (0.08%)  1/1317 (0.08%) 
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  32/1321 (2.42%)  41/1317 (3.11%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/1321 (0.08%)  0/1317 (0.00%) 
Death not associated with CTCAE term - Sudden death  1  1/1321 (0.08%)  0/1317 (0.00%) 
Flu-like syndrome  1  1/1321 (0.08%)  0/1317 (0.00%) 
Injection site reaction/extravasation changes  1  1/1321 (0.08%)  0/1317 (0.00%) 
Pain - Chest/thorax NOS  1  0/1321 (0.00%)  4/1317 (0.30%) 
Pain-Other (Specify)  1  2/1321 (0.15%)  0/1317 (0.00%) 
Hepatobiliary disorders     
Obstruction, GI - Gallbladder  1  2/1321 (0.15%)  0/1317 (0.00%) 
Cholecystitis  1  5/1321 (0.38%)  1/1317 (0.08%) 
Hepatobiliary/Pancreas-Other (Specify)  1  5/1321 (0.38%)  1/1317 (0.08%) 
Liver dysfunction/failure (clinical)  1  5/1321 (0.38%)  1/1317 (0.08%) 
Pain - Gallbladder  1  0/1321 (0.00%)  1/1317 (0.08%) 
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  7/1321 (0.53%)  5/1317 (0.38%) 
Allergy/Immunology-Other (Specify)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infections and infestations     
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant)  1  4/1321 (0.30%)  0/1317 (0.00%) 
Infection with unknown ANC - Foreign body (e.g., graft, implant, prosthesis, stent)  1  1/1321 (0.08%)  0/1317 (0.00%) 
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Catheter-related  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Wound  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix  1  1/1321 (0.08%)  2/1317 (0.15%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus  1  1/1321 (0.08%)  2/1317 (0.15%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Catheter-related  1  0/1321 (0.00%)  2/1317 (0.15%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Joint  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)  1  5/1321 (0.38%)  2/1317 (0.15%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Middle ear (otitis media)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Nerve-peripheral  1  1/1321 (0.08%)  0/1317 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus  1  1/1321 (0.08%)  1/1317 (0.08%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)  1  8/1321 (0.61%)  9/1317 (0.68%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Small bowel NOS  1  1/1321 (0.08%)  0/1317 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS  1  0/1321 (0.00%)  2/1317 (0.15%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach  1  1/1321 (0.08%)  0/1317 (0.00%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS  1  0/1321 (0.00%)  2/1317 (0.15%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Wound  1  0/1321 (0.00%)  2/1317 (0.15%) 
Infection with unknown ANC - Appendix  1  1/1321 (0.08%)  1/1317 (0.08%) 
Infection with unknown ANC - Bronchus  1  0/1321 (0.00%)  1/1317 (0.08%) 
Infection with unknown ANC - Lung (pneumonia)  1  2/1321 (0.15%)  0/1317 (0.00%) 
Infection with unknown ANC - Skin (cellulitis)  1  2/1321 (0.15%)  4/1317 (0.30%) 
Infection-Other (Specify)  1  4/1321 (0.30%)  2/1317 (0.15%) 
Injury, poisoning and procedural complications     
Wound complication, non-infectious  1  1/1321 (0.08%)  0/1317 (0.00%) 
Fracture  1  11/1321 (0.83%)  18/1317 (1.37%) 
Intra-operative injury - Ureter  1  0/1321 (0.00%)  1/1317 (0.08%) 
Intra-operative injury - Vagina  1  0/1321 (0.00%)  1/1317 (0.08%) 
Thrombosis/embolism (vascular access-related)  1  29/1321 (2.20%)  13/1317 (0.99%) 
Vessel injury-vein - Extremity-upper  1  0/1321 (0.00%)  1/1317 (0.08%) 
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  6/1321 (0.45%)  3/1317 (0.23%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  6/1321 (0.45%)  4/1317 (0.30%) 
Cholesterol, serum-high (hypercholesterolemia)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Bilirubin (hyperbilirubinemia)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Carbon monoxide diffusion capacity (DL(co))  1  1/1321 (0.08%)  0/1317 (0.00%) 
GGT (gamma-glutamyl transpeptidase)  1  2/1321 (0.15%)  4/1317 (0.30%) 
INR (International Normalized Ratio of prothrombin time)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Leukocytes (total WBC)  1  0/1321 (0.00%)  3/1317 (0.23%) 
Neutrophils/granulocytes (ANC/AGC)  1  2/1321 (0.15%)  2/1317 (0.15%) 
Weight loss  1  1/1321 (0.08%)  2/1317 (0.15%) 
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Calcium, serum-low (hypocalcemia)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Glucose, serum-high (hyperglycemia)  1  8/1321 (0.61%)  8/1317 (0.61%) 
Phosphate, serum-low (hypophosphatemia)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Potassium, serum-low (hypokalemia)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Sodium, serum-low (hyponatremia)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Triglyceride, serum-high (hypertriglyceridemia)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Dehydration  1  2/1321 (0.15%)  1/1317 (0.08%) 
Pancreatic endocrine: glucose intolerance  1  5/1321 (0.38%)  8/1317 (0.61%) 
Musculoskeletal and connective tissue disorders     
Extremity-upper (function)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Joint-function  1  1/1321 (0.08%)  1/1317 (0.08%) 
Lymphedema-related fibrosis  1  0/1321 (0.00%)  1/1317 (0.08%) 
Musculoskeletal/Soft Tissue-Other (Specify)  1  3/1321 (0.23%)  1/1317 (0.08%) 
Osteoporosis  1  4/1321 (0.30%)  8/1317 (0.61%) 
Pain - Back  1  2/1321 (0.15%)  0/1317 (0.00%) 
Pain - Bone  1  1/1321 (0.08%)  1/1317 (0.08%) 
Pain - Chest wall  1  1/1321 (0.08%)  1/1317 (0.08%) 
Pain - Extremity-limb  1  1/1321 (0.08%)  0/1317 (0.00%) 
Pain - Joint  1  69/1321 (5.22%)  139/1317 (10.55%) 
Pain - Neck  1  1/1321 (0.08%)  1/1317 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary Malignancy-possibly related to cancer treatment (Specify)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Nervous system disorders     
Hemorrhage, CNS  1  1/1321 (0.08%)  1/1317 (0.08%) 
CNS cerebrovascular ischemia  1  9/1321 (0.68%)  2/1317 (0.15%) 
Dizziness  1  2/1321 (0.15%)  3/1317 (0.23%) 
Memory impairment  1  1/1321 (0.08%)  1/1317 (0.08%) 
Neurology-Other (Specify)  1  2/1321 (0.15%)  4/1317 (0.30%) 
Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial  1  2/1321 (0.15%)  0/1317 (0.00%) 
Neuropathy: motor  1  0/1321 (0.00%)  2/1317 (0.15%) 
Neuropathy: sensory  1  1/1321 (0.08%)  0/1317 (0.00%) 
Pain - Head/headache  1  9/1321 (0.68%)  11/1317 (0.84%) 
Pain - Neuralgia/peripheral nerve  1  2/1321 (0.15%)  12/1317 (0.91%) 
Seizure  1  1/1321 (0.08%)  1/1317 (0.08%) 
Syncope (fainting)  1  1/1321 (0.08%)  4/1317 (0.30%) 
Vasovagal episode  1  0/1321 (0.00%)  1/1317 (0.08%) 
Psychiatric disorders     
Insomnia  1  54/1321 (4.09%)  44/1317 (3.34%) 
Mood alteration - anxiety  1  1/1321 (0.08%)  3/1317 (0.23%) 
Mood alteration - depression  1  59/1321 (4.47%)  51/1317 (3.87%) 
Psychosis (hallucinations/delusions)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Renal and urinary disorders     
Incontinence, urinary  1  3/1321 (0.23%)  2/1317 (0.15%) 
Obstruction, GU - Ureter  1  0/1321 (0.00%)  1/1317 (0.08%) 
Cystitis  1  1/1321 (0.08%)  0/1317 (0.00%) 
Renal/Genitourinary-Other (Specify)  1  24/1321 (1.82%)  7/1317 (0.53%) 
Reproductive system and breast disorders     
Hemorrhage, GU - Uterus  1  0/1321 (0.00%)  1/1317 (0.08%) 
Hemorrhage, GU - Vagina  1  4/1321 (0.30%)  1/1317 (0.08%) 
Breast nipple/areolar deformity  1  0/1321 (0.00%)  1/1317 (0.08%) 
Irregular menses (change from baseline)  1  0/1321 (0.00%)  1/1317 (0.08%) 
Pain - Vagina  1  11/1321 (0.83%)  33/1317 (2.51%) 
Sexual/Reproductive Function-Other (Specify)  1  3/1321 (0.23%)  1/1317 (0.08%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm, wheezing  1  2/1321 (0.15%)  0/1317 (0.00%) 
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS  1  1/1321 (0.08%)  0/1317 (0.00%) 
Apnea  1  1/1321 (0.08%)  0/1317 (0.00%) 
Cough  1  0/1321 (0.00%)  1/1317 (0.08%) 
Dyspnea (shortness of breath)  1  1/1321 (0.08%)  2/1317 (0.15%) 
Obstruction/stenosis of airway - Larynx  1  1/1321 (0.08%)  0/1317 (0.00%) 
Pleural effusion (non-malignant)  1  1/1321 (0.08%)  0/1317 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  1/1321 (0.08%)  1/1317 (0.08%) 
Pneumothorax  1  1/1321 (0.08%)  1/1317 (0.08%) 
Pulmonary/Upper Respiratory-Other (Specify)  1  2/1321 (0.15%)  2/1317 (0.15%) 
Skin and subcutaneous tissue disorders     
Pruritus/itching  1  1/1321 (0.08%)  1/1317 (0.08%) 
Rash/desquamation  1  1/1321 (0.08%)  0/1317 (0.00%) 
Skin breakdown/decubitus ulcer  1  1/1321 (0.08%)  0/1317 (0.00%) 
Vascular disorders     
Hematoma  1  0/1321 (0.00%)  1/1317 (0.08%) 
Hot flashes/flushes  1  149/1321 (11.28%)  127/1317 (9.64%) 
Hypertension  1  100/1321 (7.57%)  90/1317 (6.83%) 
Hypotension  1  1/1321 (0.08%)  0/1317 (0.00%) 
Vascular-Other (Specify)  1  1/1321 (0.08%)  0/1317 (0.00%) 
Vasculitis  1  0/1321 (0.00%)  1/1317 (0.08%) 
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%
T+OFS E+OFS
Affected / at Risk (%) Affected / at Risk (%)
Total   1293/1321 (97.88%)   1298/1317 (98.56%) 
Cardiac disorders     
Cardiac-ischemia/infarction  1  2/1321 (0.15%)  4/1317 (0.30%) 
Gastrointestinal disorders     
Nausea  1  446/1321 (33.76%)  478/1317 (36.29%) 
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  807/1321 (61.09%)  760/1317 (57.71%) 
Injection site reaction/extravasation changes  1  99/1321 (7.49%)  86/1317 (6.53%) 
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  56/1321 (4.24%)  60/1317 (4.56%) 
Injury, poisoning and procedural complications     
Fracture  1  57/1321 (4.31%)  82/1317 (6.23%) 
Thrombosis/embolism (vascular access-related)  1  3/1321 (0.23%)  3/1317 (0.23%) 
Metabolism and nutrition disorders     
Glucose, serum-high (hyperglycemia)  1  30/1321 (2.27%)  31/1317 (2.35%) 
Pancreatic endocrine: glucose intolerance  1  16/1321 (1.21%)  17/1317 (1.29%) 
Musculoskeletal and connective tissue disorders     
Osteoporosis  1  388/1321 (29.37%)  588/1317 (44.65%) 
Pain - Joint  1  953/1321 (72.14%)  1030/1317 (78.21%) 
Nervous system disorders     
Hemorrhage, CNS  1  12/1321 (0.91%)  7/1317 (0.53%) 
CNS cerebrovascular ischemia  1  2/1321 (0.15%)  1/1317 (0.08%) 
Psychiatric disorders     
Insomnia  1  738/1321 (55.87%)  714/1317 (54.21%) 
Libido  1  486/1321 (36.79%)  555/1317 (42.14%) 
Mood alteration - depression  1  592/1321 (44.81%)  610/1317 (46.32%) 
Renal and urinary disorders     
Incontinence, urinary  1  232/1321 (17.56%)  182/1317 (13.82%) 
Reproductive system and breast disorders     
Pain - Vagina  1  336/1321 (25.44%)  374/1317 (28.40%) 
Vaginal dryness  1  611/1321 (46.25%)  683/1317 (51.86%) 
Skin and subcutaneous tissue disorders     
Sweating (diaphoresis)  1  752/1321 (56.93%)  705/1317 (53.53%) 
Vascular disorders     
Hot flashes/flushes  1  1081/1321 (81.83%)  1076/1317 (81.70%) 
Hypertension  1  179/1321 (13.55%)  213/1317 (16.17%) 
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 NOT 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: NCT00066703     History of Changes
Other Study ID Numbers: IBCSG 25-02 / BIG 3-02
IBCSG 25-02
BIG 3-02 ( Other Identifier: Breast International Group )
NABCI IBCSG 25-02
EU-20347
2004-000168-28 ( EudraCT Number )
CDR0000316458 ( Registry Identifier: CT.gov )
First Submitted: August 6, 2003
First Posted: August 7, 2003
Results First Submitted: July 14, 2015
Results First Posted: April 5, 2016
Last Update Posted: January 23, 2018