RESTORING SENSITIVITY TO IMMUNOTHERAPY IN ADVANCED TRIPLE NEGATIVE BREAST CANCER EXPLOITING CERALASERTIB PRIMING FOLLOWED BY COMBINED DURVALUMAB/NAB-PACLITAXEL: THE ATRiBRAVE TRIAL

Conditions

ADVANCED TRIPLE NEGATIVE BREAST CANCER

Brief summary

Progression free survival (PFS), defined as the number of days between the first study treatment administration to the date of first documented disease progression, relapse or death from any cause.

Detailed description

Overall Response Rate (ORR) according to RECIST v 1.1 criteria, Disease Control Rate (DCR) defined as the percentage of subjects whose disease shrinks or remains stable at 12 weeks. DCR is the sum of the complete response (CR), partial response (PR) and stable disease (SD) rates, Clinical Benefit Rate (CBR) defined as the proportion of patients with no disease progression at 24 weeks, Duration of Response (DoR) defined as the time from the date of first documented confirmed response until date of documented progression per RECIST v1.1 or death due to any cause, Overall Survival (OS) defined as the number of days between the first study treatment administration and death, Occurrence of Adverse Events (AEs), including treatment-related AEs and AEs of special interest

Related papers

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Interventions

DRUGDURVALUMAB

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGCeralasertib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS), defined as the number of days between the first study treatment administration to the date of first documented disease progression, relapse or death from any cause.	—

Secondary

Measure	Time frame
Overall Response Rate (ORR) according to RECIST v 1.1 criteria, Disease Control Rate (DCR) defined as the percentage of subjects whose disease shrinks or remains stable at 12 weeks. DCR is the sum of the complete response (CR), partial response (PR) and stable disease (SD) rates, Clinical Benefit Rate (CBR) defined as the proportion of patients with no disease progression at 24 weeks, Duration of Response (DoR) defined as the time from the date of first documented confirmed response until date of documented progression per RECIST v1.1 or death due to any cause, Overall Survival (OS) defined as the number of days between the first study treatment administration and death, Occurrence of Adverse Events (AEs), including treatment-related AEs and AEs of special interest	—

Measure

Time frame

Overall Response Rate (ORR) according to RECIST v 1.1 criteria, Disease Control Rate (DCR) defined as the percentage of subjects whose disease shrinks or remains stable at 12 weeks. DCR is the sum of the complete response (CR), partial response (PR) and stable disease (SD) rates, Clinical Benefit Rate (CBR) defined as the proportion of patients with no disease progression at 24 weeks, Duration of Response (DoR) defined as the time from the date of first documented confirmed response until date of documented progression per RECIST v1.1 or death due to any cause, Overall Survival (OS) defined as the number of days between the first study treatment administration and death, Occurrence of Adverse Events (AEs), including treatment-related AEs and AEs of special interest

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Countries

Italy

Outcome results

None listed