Phase II study to improve sacituzumab govitecan tolerance with atropine in patients with advanced triple-negative and hormone receptor-positive/HER2-negative breast cancer (The SATROPIN Study).

Trial status: Authorised Overall safety profile according to the NCI-CTCAE v.5.0 during the first two treatment cycles and the extended follow-up., Incidence of all grades diarrhea during the first two treatment cycles and during the extended follow-up, as assessed by the Investigator, with severity determined by NCI-CTCAE v.5.0., Incidence of all grades constipation during the first two treatment cycles and during the extended follow-up, as assessed by the Investigator, with severity determined by NCI-CTCAE v.5.0., Dose reduction rate, defined as the proportion of participants with dose reduction due to toxicity relative to the number of participants in the analysis set., Dose interruption rate, defined as the proportion of participants with dose interruption due to toxicity relative to the number of participants in the analysis set., Discontinuation rate, defined as the proportion of participants who discontinued Study treatment to any cause relative to the number of participants in the analysis set., rwPFS, defined as the time between start of treatment to date of disease progression or death documented in participant medical charts, whichever date came first., TTF, defined as the time from the start of treatment to its discontinuation for any reason, including disease progression, treatment-related toxicity, participant withdrawal, or death., TTF-Toxicity, defined as the time from the start of treatment to its discontinuation especially due to treatment-related adverse events (TEAEs). It excludes discontinuation for other reasons such as disease progression, participant withdrawal, or death unrelated to toxicity., OS, defined as the period from treatment initiation to death from any cause, as determined locally by the Investigator., Incidence of all grades constipation during the first two treatment cycles, as assessed by the Investigator, withseverity determined by the NCI-CTCAE v.6.0. Incidence of grade ≥2 diarrhea during the first two treatment cycles as assessed by the Investigator, with severity determined by the NCI-CTCAE v.5.0.

Overall safety profile according to the NCI-CTCAE v.5.0 during the first two treatment cycles and the extended follow-up., Incidence of all grades diarrhea during the first two treatment cycles and during the extended follow-up, as assessed by the Investigator, with severity determined by NCI-CTCAE v.5.0., Incidence of all grades constipation during the first two treatment cycles and during the extended follow-up, as assessed by the Investigator, with severity determined by NCI-CTCAE v.5.0., Dose reduction rate, defined as the proportion of participants with dose reduction due to toxicity relative to the number of participants in the analysis set., Dose interruption rate, defined as the proportion of participants with dose interruption due to toxicity relative to the number of participants in the analysis set., Discontinuation rate, defined as the proportion of participants who discontinued Study treatment to any cause relative to the number of participants in the analysis set., rwPFS, defined as the time between start of treatment to date of disease progression or death documented in participant medical charts, whichever date came first., TTF, defined as the time from the start of treatment to its discontinuation for any reason, including disease progression, treatment-related toxicity, participant withdrawal, or death., TTF-Toxicity, defined as the time from the start of treatment to its discontinuation especially due to treatment-related adverse events (TEAEs). It excludes discontinuation for other reasons such as disease progression, participant withdrawal, or death unrelated to toxicity., OS, defined as the period from treatment initiation to death from any cause, as determined locally by the Investigator., Incidence of all grades constipation during the first two treatment cycles, as assessed by the Investigator, withseverity determined by the NCI-CTCAE v.6.0.

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 30 participants