PQR309 and Eribulin Combination Safety and Efficacy in HER2 Negative and Triple-Negative Breast Cancer

PQR309

Eribulin

Number of patients with treatment related Adverse Events and Serious Adverse Events as assessed by NCI CTCAEV4.03

RECIST the Response criteria for solid tumors will be used to identify clinical benefit rate (CBR) including complete Response (CR), partial Response (PR) and stable disease (SD)

Number of patients with Adverse Events and Serious Adverse Events and number of anormal laboratory values that constitute an Adverse Events on their own

Number and percent of patients having each ECOG (Eastern Oncology Cooperative Group) performance status level will be presented for baseline and each post-baseline measurement.

Assessment of PQR309 and Eribulin blood concentration

Physical examination, Body weight in kg

Physical examination, ECG

Vital signs like heart rate

Vital signs like blood pressure

Vital signs like body temperature

Objective Response Rate (ORR), is defined as the best overall response (confirmed CR or PR) recorded for each patient since baseline.

Time to Response (TTR) is defined, for patients with tumor response, as the time from the date of study entry to the first documentation of response (complete or partial)

Duration of response (DOR) is defined, for the patients with tumor response, as the time from the date of the first confirmed response to disease progression.

Progression- free survival (PFS) is defined as the time from study entry to progression or death due to any cause

Time to treatment failure (TTF) is defined as the time from study entry to any treatment failure including disease progression or discontinuation of treatment

1-year survival, defined as the time from study entry to death as a result of any cause at 1-year cut-off date

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC(Racemate)

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24

PK parameters of PQR309 and eribulin will include: AUC0-∞

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: cmax

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-24

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: AUC0-∞

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: t1/2

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: tmax

Pharmacokinetic (PK) parameters of PQR309 and eribulin will include: RAC (Racemate)

Changes in glucose levels

Changes in Insulin levels

Changes of Routine laboratory -Haematology

Changes of Routine laboratory -blood chemistry

Changes of Routine laboratory -urinanalysis