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Trial record 19 of 190 for:    Oral Cancer | ( Map: Mexico )

A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00022672
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : June 13, 2013
Last Update Posted : June 13, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: trastuzumab (Herceptin®)
Drug: anastrazole (Arimidex®)
Enrollment 208
Recruitment Details  
Pre-assignment Details 208 participants were randomized. 1 participant did not receive study drug. After the completion of the 24 month Main Phase or disease progression, participants in the anastrozole-alone treatment arm entered the Extension Phase where they received trastuzumab + anastrozole.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase. 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Period Title: Main Phase: 24 Months
Started 103 104
Safety Set: Received Study Drug 103 104
Completed 16 4
Not Completed 87 100
Reason Not Completed
Adverse Event             6             0
Death             0             3
Insufficient Therapeutic Response             75             91
Violation of Selection Criteria at Entry             0             1
Other Protocol Violation             1             0
Refused Treatment             3             4
Failure to Return             1             1
Other             1             0
Period Title: Extension Phase
Started 14 [1] 58
Safety Set: Received Study Drug 14 58
Completed 11 7
Not Completed 3 51
Reason Not Completed
Adverse Event             1             3
Death             0             1
Insufficient Therapeutic Response             1             44
Refused Treatment             0             2
Other             1             1
[1]
2 patients completed Main Phase; but did not enter Extension (1-did not cooperate and 1-withdrew).
Arm/Group Title Trastuzumab + Anastrozole Anastrozole Total
Hide Arm/Group Description Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase. 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes. Total of all reporting groups
Overall Number of Baseline Participants 103 104 207
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 104 participants 207 participants
57.4  (10.6) 55.5  (10.7) 56.5  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 104 participants 207 participants
Female
103
 100.0%
104
 100.0%
207
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.
Time Frame 24 Months, End of Study (Up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population included all randomized participants who received study drug.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Median (95% Confidence Interval)
Unit of Measure: Months
24 Months
4.8
(3.7 to 7)
2.4
(2 to 4.6)
End of Study
5.8
(4.6 to 8.3)
2.9
(2.1 to 4.5)
2.Secondary Outcome
Title Percentage of Participants With Clinical Benefit
Hide Description Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.
Time Frame 24 Months, End of Study (Up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: Percentage of participants
24 Months 42.7 27.9
End of Study 45.6 30.8
3.Secondary Outcome
Title Duration of Response at 24 Months
Hide Description Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 74 73
Median (Full Range)
Unit of Measure: Months
9.5
(3.8 to 50.6)
10.0
(5.3 to 33.1)
4.Secondary Outcome
Title Time to Response at 24 Months
Hide Description Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 74 73
Median (Full Range)
Unit of Measure: Months
2.0
(1.4 to 12.1)
2.0
(1.7 to 4.1)
5.Secondary Outcome
Title Overall Survival at 24 Months
Hide Description Overall Survival is defined as the number of days from randomization to death.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Median (95% Confidence Interval)
Unit of Measure: Months
28.5
(22.8 to 42.4)
23.9
(18.2 to 37.4)
6.Secondary Outcome
Title Percentage of Participants With Two-Year Survival
Hide Description [Not Specified]
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population included all randomized participants who received study drug.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: Percentage of participants
52.4 45.2
7.Secondary Outcome
Title Percentage of Participants With Overall Tumor Response at 24 Months
Hide Description Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 74 73
Measure Type: Number
Unit of Measure: Percentage of participants
20.3 6.8
8.Secondary Outcome
Title Percentage of Participants With Best Tumor Response at 24 Months
Hide Description Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 74 73
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response 0.0 0.0
Partial Response 20.3 6.8
Stable Disease 37.8 38.4
Progressive Disease 40.5 49.3
Response not assessed 1.4 5.5
9.Secondary Outcome
Title Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline
Hide Description

Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.

The percentage of participants in the following categories:

Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline.

Time Frame Baseline, Final Visit (Up to 24 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Population (includes all randomized participants who received study drug) with data available for analyses.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 68 73
Measure Type: Number
Unit of Measure: Percentage of participants
Improved 10.3 4.1
No Change 67.6 64.4
Worse 22.1 31.5
10.Secondary Outcome
Title Duration of Response at End of Study
Hide Description Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.
Time Frame End of Study (Up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Median (Full Range)
Unit of Measure: Months
12.3
(3 to 59.1)
8.2
(2.6 to 60.5)
11.Secondary Outcome
Title Time to Response at End of Study
Hide Description Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.
Time Frame End of Study (Up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Median (Full Range)
Unit of Measure: Months
2.4
(1.7 to 12.1)
2.1
(1.3 to 5.1)
12.Secondary Outcome
Title Percentage of Participants With Overall Tumor Response at End of Study
Hide Description Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.
Time Frame End of Study (Up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: Percentage of participants
22.3 8.7
13.Secondary Outcome
Title Percentage of Participants With Best Tumor Response at End of Study
Hide Description Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.
Time Frame End of Study (Up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population includes all randomized participants who received study drug.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: Percentage of participants
Complete Response 1.0 3.8
Partial Response 21.4 4.8
Stable Disease 47.6 40.4
Progressive Disease 28.1 46.2
Response not assessed 1.9 4.8
14.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.
Time Frame Throughout the Study (Up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least one dose of study drug.
Arm/Group Title Trastuzumab + Anastrozole Anastrozole
Hide Arm/Group Description:
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
Overall Number of Participants Analyzed 103 104
Measure Type: Number
Unit of Measure: Participants
90 68
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trastuzumab + Anastrozole Anastrozole Anastrozole (After Start of Trastuzumab)
Hide Arm/Group Description Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase. 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
All-Cause Mortality
Trastuzumab + Anastrozole Anastrozole Anastrozole (After Start of Trastuzumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Trastuzumab + Anastrozole Anastrozole Anastrozole (After Start of Trastuzumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/103 (24.27%)   6/104 (5.77%)   8/58 (13.79%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  1/103 (0.97%)  1/104 (0.96%)  0/58 (0.00%) 
Cardiac disorders       
Myocardial infarction  1  1/103 (0.97%)  1/104 (0.96%)  0/58 (0.00%) 
Myocardial ischaemia  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Ear and labyrinth disorders       
Middle ear inflammation  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Gastrointestinal disorders       
Vomiting  1  3/103 (2.91%)  0/104 (0.00%)  0/58 (0.00%) 
Nausea  1  2/103 (1.94%)  0/104 (0.00%)  0/58 (0.00%) 
Abdominal pain  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Constipation  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Diarrhoea  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Gastritis  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Intestinal obstruction  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Small intestinal obstruction  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Dyspepsia  1  0/103 (0.00%)  0/104 (0.00%)  1/58 (1.72%) 
General disorders       
Chest pain  1  3/103 (2.91%)  0/104 (0.00%)  0/58 (0.00%) 
Pain  1  2/103 (1.94%)  0/104 (0.00%)  0/58 (0.00%) 
Pyrexia  1  1/103 (0.97%)  1/104 (0.96%)  0/58 (0.00%) 
Asthenia  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Sudden death  1  0/103 (0.00%)  0/104 (0.00%)  1/58 (1.72%) 
Hepatobiliary disorders       
Cholelithiasis  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Infections and infestations       
Catheter related infection  1  0/103 (0.00%)  1/104 (0.96%)  0/58 (0.00%) 
Folliculitis  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Lower respiratory tract infection  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Malaria  1  0/103 (0.00%)  1/104 (0.96%)  0/58 (0.00%) 
Respiratory tract infection  1  0/103 (0.00%)  1/104 (0.96%)  0/58 (0.00%) 
Streptococcal sepsis  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Urinary tract infection pseudomonal  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Fall  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Femur fracture  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Hip fracture  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Humerus fracture  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Upper limb fracture  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Lumbar vertebral fracture  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Metabolism and nutrition disorders       
Hypercalcaemia  1  2/103 (1.94%)  0/104 (0.00%)  0/58 (0.00%) 
Dehydration  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Hyponatraemia  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/103 (0.00%)  1/104 (0.96%)  0/58 (0.00%) 
Back pain  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Pathological fracture  1  1/103 (0.97%)  0/104 (0.00%)  1/58 (1.72%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cervix carcinoma  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Endometrial cancer  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Nervous system disorders       
Headache  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Psychiatric disorders       
Depression  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Renal and urinary disorders       
Renal failure acute  1  0/103 (0.00%)  1/104 (0.96%)  0/58 (0.00%) 
Urinary retention  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Ureteric obstruction  1  0/103 (0.00%)  0/104 (0.00%)  1/58 (1.72%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/103 (0.97%)  1/104 (0.96%)  1/58 (1.72%) 
Pneumothorax  1  0/103 (0.00%)  0/104 (0.00%)  1/58 (1.72%) 
Skin and subcutaneous tissue disorders       
Exfoliative rash  1  0/103 (0.00%)  0/104 (0.00%)  1/58 (1.72%) 
Vascular disorders       
Hypertension  1  1/103 (0.97%)  0/104 (0.00%)  1/58 (1.72%) 
Hypotension  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Venous insufficiency  1  1/103 (0.97%)  0/104 (0.00%)  0/58 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trastuzumab + Anastrozole Anastrozole Anastrozole (After Start of Trastuzumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   89/103 (86.41%)   68/104 (65.38%)   40/58 (68.97%) 
Blood and lymphatic system disorders       
Neutropenia  1  0/103 (0.00%)  0/104 (0.00%)  3/58 (5.17%) 
Eye disorders       
Lacrimation increased  1  1/103 (0.97%)  0/104 (0.00%)  4/58 (6.90%) 
Gastrointestinal disorders       
Constipation  1  11/103 (10.68%)  5/104 (4.81%)  3/58 (5.17%) 
Diarrhoea  1  20/103 (19.42%)  8/104 (7.69%)  8/58 (13.79%) 
Nausea  1  15/103 (14.56%)  5/104 (4.81%)  5/58 (8.62%) 
Vomiting  1  21/103 (20.39%)  5/104 (4.81%)  5/58 (8.62%) 
General disorders       
Chills  1  15/103 (14.56%)  0/104 (0.00%)  3/58 (5.17%) 
Fatigue  1  22/103 (21.36%)  10/104 (9.62%)  4/58 (6.90%) 
Oedema peripheral  1  7/103 (6.80%)  2/104 (1.92%)  4/58 (6.90%) 
Pyrexia  1  17/103 (16.50%)  6/104 (5.77%)  4/58 (6.90%) 
Mucosal inflammation  1  5/103 (4.85%)  0/104 (0.00%)  4/58 (6.90%) 
Infections and infestations       
Influenza  1  7/103 (6.80%)  4/104 (3.85%)  1/58 (1.72%) 
Nasopharyngitis  1  17/103 (16.50%)  2/104 (1.92%)  2/58 (3.45%) 
Investigations       
Weight decreased  1  9/103 (8.74%)  4/104 (3.85%)  3/58 (5.17%) 
Weight increased  1  9/103 (8.74%)  4/104 (3.85%)  1/58 (1.72%) 
Metabolism and nutrition disorders       
Anorexia  1  7/103 (6.80%)  2/104 (1.92%)  3/58 (5.17%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  15/103 (14.56%)  9/104 (8.65%)  3/58 (5.17%) 
Back pain  1  15/103 (14.56%)  7/104 (6.73%)  3/58 (5.17%) 
Bone pain  1  11/103 (10.68%)  6/104 (5.77%)  2/58 (3.45%) 
Musculoskeletal pain  1  13/103 (12.62%)  3/104 (2.88%)  3/58 (5.17%) 
Myalgia  1  3/103 (2.91%)  2/104 (1.92%)  4/58 (6.90%) 
Pain in extremity  1  6/103 (5.83%)  4/104 (3.85%)  3/58 (5.17%) 
Nervous system disorders       
Dizziness  1  10/103 (9.71%)  4/104 (3.85%)  2/58 (3.45%) 
Headache  1  14/103 (13.59%)  6/104 (5.77%)  2/58 (3.45%) 
Psychiatric disorders       
Depression  1  6/103 (5.83%)  1/104 (0.96%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  15/103 (14.56%)  6/104 (5.77%)  4/58 (6.90%) 
Dyspnoea  1  14/103 (13.59%)  9/104 (8.65%)  4/58 (6.90%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  4/103 (3.88%)  2/104 (1.92%)  6/58 (10.34%) 
Rash  1  6/103 (5.83%)  6/104 (5.77%)  1/58 (1.72%) 
Vascular disorders       
Hot flush  1  9/103 (8.74%)  3/104 (2.88%)  0/58 (0.00%) 
Hypertension  1  6/103 (5.83%)  4/104 (3.85%)  2/58 (3.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00022672     History of Changes
Obsolete Identifiers: NCT00112450
Other Study ID Numbers: BO16216
First Submitted: August 10, 2001
First Posted: January 27, 2003
Results First Submitted: April 2, 2013
Results First Posted: June 13, 2013
Last Update Posted: June 13, 2013