Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, willingness and ability to complete collection of data via wearable device and study mobile must be obtained and documented according to the local regulatory requirements.
Female or male patients.
Age = 18 years old.
Metastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed).
Patients who in the opinion of the treating physician are candidates suitable for randomization for mono-chemotherapy treatment, that has either an approved label in Europe and/or is supported by guidelines for the treatment of first-line advanced BC, which are based on evidence on safety and efficacy in this setting.
Symptomatic or asymptomatic metastatic breast cancer.
Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 grade = 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
Life-expectancy > 6 months.
For female patients: The patients need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) B) childbearing potential with negative serum or urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive methods).

NCT03355157_inc_T2
Person
Female
NCT03355157_inc_T3
Person
male
NCT03355157_inc_T4
Person
Age
NCT03355157_inc_T5
Value
= 18 years old
NCT03355157_inc_T6
Condition
breast cancer
NCT03355157_inc_T7
Qualifier
invasive
NCT03355157_inc_T8
Qualifier
Metastatic
NCT03355157_inc_T9
Qualifier
hormone receptor positive
NCT03355157_inc_T10
Qualifier
HER2 negative
NCT03355157_inc_T11
Scope
Metastatic invasive hormone receptor positive and HER2 negative
NCT03355157_inc_T14
Condition
metastatic breast cancer
NCT03355157_inc_T15
Qualifier
asymptomatic
NCT03355157_inc_T16
Qualifier
Symptomatic
NCT03355157_inc_T17
Scope
Symptomatic or asymptomatic
NCT03355157_inc_T18
Observation
Life-expectancy
NCT03355157_inc_T19
Value
> 6 months
NCT03355157_inc_T20
Measurement
NCI CTCAE version 4.0
NCT03355157_inc_T21
Value
grade = 1
NCT03355157_inc_T22
Observation
Resolution
NCT03355157_inc_T23
Condition
acute toxic effects
NCT03355157_inc_T24
Procedure
anti-cancer therapy
NCT03355157_inc_T25
Procedure
surgical procedure
NCT03355157_inc_T26
Scope
anti-cancer therapy or surgical procedures
NCT03355157_inc_T27
Qualifier
prior
NCT03355157_inc_T28
Negation
except
NCT03355157_inc_T29
Condition
alopecia