A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
NCT Number: NCT06508216
Acronym: COMPASS-TNBC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Breast Cancer
Interventions: DRUG: Dato-DXd|DRUG: Durvalumab
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Collaborators: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2027-12-17
Locations: Gustave Roussy, Villejuif, France

Summary:
Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer:

A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and anti-tumor activity of novel therapeutics in patients with early relapsed metastatic triple-negative breast cancer

Primary Outcome Measures: Part 2_Efficacy of study therapies in each module_objective response rate (ORR) at 6 months., ORR is defined as the proportion of patients who achieved a confirmed CR or PR within the 6 months of treatment initiation assessed by investigators., Within the 6 months of treatment initiation|Part 1_Safety and to determine the recommended phase II dose (RP2D) of study therapies in each module, measured by the DLTs, frequency and severity of any AEs, TEAEs, SAEs, AESIs graded according to NCI-CTCAE v5.0, proportion of treatment discontinuations, interruptions, and dose reductions due to any AEs; frequency and severity of laboratory abnormalities defined by NCI-CTCAE v5.0, During treatment_to be determined according to modules added later on
Secondary Outcome Measures: Part 1&2_Progression free survival (PFS), Defined as the time from the date of first dose until the date of the first objective documentation of disease progression or death from any cause, whichever occurs first. For patients without documented radiological progression, PFS will be censored at the date of last adequate radiological assessment without progression, unless death occurs within ≤ 2 missing assessments following the date of last known progression-free, in which case the death will be counted as a PFS event., From the time date of the first dose until progression or death from any cause, whichever occurs first|Part 1&2_Duration of response (DOR), Defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progression (PD) or death due to any cause, whichever occurs first. Duration of response will be measured for responding patients (CR or PR) only., From cycle 3 (Week 6; each cycle is 28 days) up to 2 years after the EoT, an average of 33 months|Part 1&2_Clinical benefit rate (CBR), Defined as the proportion of patients with a complete (CR) or partial response (PR) or with stable disease (SD) \> 6 months., During treatment period, a median of 6 months|Part 1&2_Overall survival (OS), Defined as the time from the date of first dose until death. Patients alive at last follow-up will be censored at this date., From the date of the first dose until 24 months after EoT|Part 2_Frequency of all adverse events, From enrollment to 30 days after EoT for module 1 and for 90 days for module 2|Part 2_Severity of all adverse events, As defined by the NCI-CTCAE v5.0., From enrollment to 30 days after Eo for module 1 and for 90 days for module 2|Part 2_Frequency of laboratory abnormalities, From enrollment until progression, median of 6 months|Severity of laboratory abnormalities, Defined by NCI-CTCAE v5.0, From enrollment until progression, median of 6 months|Proportion of treatment discontinuation due to any AEs., Treatment Period, median of 6 months|Proportion of treatment interruptions due to any AEs., Treatment Period, median of 6 months|Proportion of dose reductions due to any AEs., Treatment Period, median of 6 months|Part 1_efficacy of study therapies in each module_objective response rate (ORR), ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) assessed by investigators. The objective response will be radiologically assessed every 6 weeks using RECIST v1.1., Within the 6 months of treatment initiation