History of any chemotherapy for MBC. 
An interval of < 6 months from the completion of cytotoxic chemotherapy in the neo-adjuvant or adjuvant setting until the time of metastatic diagnosis. 
Trastuzumab ≤ 21 days prior to randomization. 
Hormone therapy < 7 days prior to randomization. 
Current peripheral neuropathy of Grade ≥ 3. 
History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned. 
Previous radiotherapy for the treatment of unresectable, locally advanced or metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization. 
Brain metastases that are untreated, symptomatic, or require therapy to control symptoms or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to randomization. 
History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2. 
Current unstable angina. 
History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment. 
History of myocardial infarction within 6 months prior to randomization. 
Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization. 
History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment. 
Cardiac troponin I ≥ 0.2 ng/mL within 28 days of randomization. 
Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy. 
Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures). 
Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment. 
Current pregnancy or lactation. 
History of receiving any investigational treatment within approximately 28 days prior to randomization. 
Current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus. 
History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel. 
Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80. 
Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.       
    

NCT00679341_exc_T1
Procedure
chemotherapy
NCT00679341_exc_T2
Condition
MBC
NCT00679341_exc_T3
Observation
History
NCT00679341_exc_T4
Value
< 6 months
NCT00679341_exc_T5
Procedure
cytotoxic chemotherapy
NCT00679341_exc_T6
Qualifier
neo-adjuvant setting
NCT00679341_exc_T7
Qualifier
adjuvant setting
NCT00679341_exc_T8
Condition
metastatic diagnosis
NCT00679341_exc_T9
Drug
Trastuzumab
NCT00679341_exc_T10
Temporal
≤ 21 days prior to randomization
NCT00679341_exc_T11
Reference_point
randomization
NCT00679341_exc_T12
Procedure
Hormone therapy
NCT00679341_exc_T13
Temporal
< 7 days prior to randomization
NCT00679341_exc_T14
Reference_point
randomization
NCT00679341_exc_T15
Condition
peripheral neuropathy
NCT00679341_exc_T16
Qualifier
Grade ≥ 3
NCT00679341_exc_T17
Measurement
Grade
NCT00679341_exc_T18
Value
≥ 3
NCT00679341_exc_T19
Temporal
Current
NCT00679341_exc_T20
Temporal
within the last 5 years
NCT00679341_exc_T21
Condition
carcinoma in situ of the cervix
NCT00679341_exc_T22
Qualifier
appropriately treated
NCT00679341_exc_T23
Procedure
treated
NCT00679341_exc_T24
Condition
non-melanoma skin carcinoma
NCT00679341_exc_T25
Condition
uterine cancer
NCT00679341_exc_T26
Measurement
Stage
NCT00679341_exc_T27
Value
I
NCT00679341_exc_T28
Condition
malignancy
NCT00679341_exc_T29
Qualifier
other
NCT00679341_exc_T30
Negation
except for
NCT00679341_exc_T32
Scope
appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer
NCT00679341_exc_T33
Procedure
radiotherapy
NCT00679341_exc_T34
Temporal
Previous
NCT00679341_exc_T35
Condition
breast cancer
NCT00679341_exc_T36
Qualifier
metastatic
NCT00679341_exc_T37
Qualifier
locally advanced
NCT00679341_exc_T38
Qualifier
unresectable
NCT00679341_exc_T39
Scope
unresectable, locally advanced or metastatic
NCT00679341_exc_T40
Value
more than 25%
NCT00679341_exc_T41
Measurement
marrow-bearing bone irradiated
NCT00679341_exc_T43
Condition
Brain metastases
NCT00679341_exc_T44
Qualifier
untreated
NCT00679341_exc_T45
Qualifier
symptomatic
NCT00679341_exc_T46
Qualifier
require therapy
NCT00679341_exc_T47
Procedure
radiation
NCT00679341_exc_T48
Procedure
surgery
NCT00679341_exc_T49
Procedure
other therapy to control symptoms
NCT00679341_exc_T50
Condition
brain metastases
NCT00679341_exc_T51
Temporal
within 2 months prior to randomization
NCT00679341_exc_T52
Reference_point
randomization
NCT00679341_exc_T53
Scope
radiation, surgery, or other therapy to control symptoms
NCT00679341_exc_T54
Scope
untreated, symptomatic, or require therapy
NCT00679341_exc_T55
Drug
anthracyclines
NCT00679341_exc_T56
Drug
Doxorubicin
NCT00679341_exc_T57
Drug
liposomal doxorubicin
NCT00679341_exc_T58
Multiplier
> 500 mg/m^2
NCT00679341_exc_T59
Drug
epirubicin
NCT00679341_exc_T60
Multiplier
> 900 mg/m^2
NCT00679341_exc_T61
Drug
mitoxantrone
NCT00679341_exc_T62
Multiplier
> 120mg/m^2
NCT00679341_exc_T63
Drug
idarubicin
NCT00679341_exc_T64
Multiplier
> 90 mg/m^2
NCT00679341_exc_T65
Scope
Doxorubicin or liposomal doxorubicin
NCT00679341_exc_T66
Scope
Doxorubicin or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2
NCT00679341_exc_T67
Scope
exposure to the following cumulative doses of anthracyclines
NCT00679341_exc_T68
Condition
unstable angina
NCT00679341_exc_T69
Temporal
Current
NCT00679341_exc_T70
Condition
congestive heart failure
NCT00679341_exc_T71
Qualifier
symptomatic
NCT00679341_exc_T72
Condition
ventricular arrhythmia
NCT00679341_exc_T73
Qualifier
requiring treatment
NCT00679341_exc_T74
Procedure
treatment
NCT00679341_exc_T75
Condition
myocardial infarction
NCT00679341_exc_T76
Temporal
within 6 months prior to randomization
NCT00679341_exc_T77
Reference_point
randomization
NCT00679341_exc_T78
Measurement
Left ventricular ejection fraction (LVEF)
NCT00679341_exc_T79
Value
below 50%
NCT00679341_exc_T80
Temporal
within approximately 28 days prior to randomization
NCT00679341_exc_T81
Reference_point
randomization
NCT00679341_exc_T82
Condition
congestive heart failure (CHF)
NCT00679341_exc_T83
Qualifier
symptomatic
NCT00679341_exc_T84
Measurement
LVEF
NCT00679341_exc_T85
Value
decreased
NCT00679341_exc_T86
Drug
trastuzumab
NCT00679341_exc_T87
Qualifier
adjuvant
NCT00679341_exc_T88
Temporal
previous
NCT00679341_exc_T89
Scope
symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment
NCT00679341_exc_T90
Observation
History
NCT00679341_exc_T91
Measurement
Cardiac troponin I
NCT00679341_exc_T92
Value
≥ 0.2 ng/mL
NCT00679341_exc_T93
Temporal
within 28 days of randomization
NCT00679341_exc_T94
Reference_point
randomization
NCT00679341_exc_T95
Condition
dyspnea
NCT00679341_exc_T96
Qualifier
Severe
NCT00679341_exc_T97
Condition
advanced malignancy
NCT00679341_exc_T98
Procedure
continuous oxygen therapy
NCT00679341_exc_T99
Temporal
current
NCT00679341_exc_T100
Condition
complications
NCT00679341_exc_T101
Qualifier
requiring current continuous oxygen therapy
NCT00679341_exc_T102
Scope
complications of advanced malignancy or requiring current continuous oxygen therapy
NCT00679341_exc_T107
Condition
lactation
NCT00679341_exc_T108
Condition
pregnancy
NCT00679341_exc_T109
Temporal
Current
NCT00679341_exc_T110
Scope
pregnancy or lactation
NCT00679341_exc_T113
Condition
human immunodeficiency virus (HIV)
NCT00679341_exc_T114
Temporal
Current
NCT00679341_exc_T115
Condition
hepatitis B virus
NCT00679341_exc_T116
Condition
hepatitis C virus
NCT00679341_exc_T117
Condition
intolerance
NCT00679341_exc_T118
Condition
infusion reaction
NCT00679341_exc_T119
Measurement
Grade
NCT00679341_exc_T120
Value
3-4
NCT00679341_exc_T121
Condition
hypersensitivity
NCT00679341_exc_T122
Drug
trastuzumab
NCT00679341_exc_T123
Drug
murine proteins
NCT00679341_exc_T124
Drug
docetaxel
NCT00679341_exc_T125
Scope
trastuzumab, murine proteins, or docetaxel
NCT00679341_exc_T103
Qualifier
severe
NCT00679341_exc_T104
Qualifier
uncontrolled
NCT00679341_exc_T105
Condition
systemic disease
NCT00679341_exc_T106
Qualifier
clinically significant
NCT00679341_exc_T129
Condition
pulmonary disease
NCT00679341_exc_T130
Condition
metabolic disease
NCT00679341_exc_T128
Condition
cardiovascular disease
NCT00679341_exc_T131
Condition
wound healing disorders
NCT00679341_exc_T132
Condition
ulcers
NCT00679341_exc_T133
Condition
bone fractures
NCT00679341_exc_T134
Scope
cardiovascular, pulmonary, or metabolic disease
NCT00679341_exc_T135
Scope
clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures
NCT00679341_exc_T111
Procedure
investigational treatment
NCT00679341_exc_T112
Temporal
within approximately 28 days prior to randomization
NCT00679341_exc_T136
Reference_point
randomization
NCT00679341_exc_T126
Condition
hypersensitivity
NCT00679341_exc_T137
Drug
study drugs
NCT00679341_exc_T138
Drug
drugs formulated in polysorbate 80
NCT00679341_exc_T139
Scope
study drugs, including the excipients, or any drugs formulated in polysorbate 80
NCT00679341_exc_T127
Observation
unwilling to comply with the requirements of the protocol
NCT00679341_exc_T140
Observation
unable to comply with the requirements of the protocol
NCT00679341_exc_T141
Qualifier
Major
NCT00679341_exc_T142
Procedure
surgical procedure
NCT00679341_exc_T143
Qualifier
significant
NCT00679341_exc_T144
Condition
traumatic injury
NCT00679341_exc_T145
Temporal
within approximately 28 days prior to randomization
NCT00679341_exc_T146
Reference_point
randomization
NCT00679341_exc_T147
Scope
Major surgical procedure or significant traumatic injury
NCT00679341_exc_T148
Mood
anticipation of the need
NCT00679341_exc_T149
Procedure
major surgery
NCT00679341_exc_T150
Temporal
during the course of study treatment
NCT00679341_exc_T151
Reference_point
study treatment
NCT00679341_exc_T152
Procedure
treatment
NCT00679341_exc_T153
Observation
History of
NCT00679341_exc_T154
Observation
History of
NCT00679341_exc_T155
Scope
Grade 3-4 infusion reaction
NCT00679341_exc_T156
Scope
intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel