Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedSIR
About this trial
The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) or hormone receptor-positive/HER2-negative (HR(+)/HER2-) treated with sacituzumab govitecan.
Eligibility criteria
Qualifiers
Participant, or legal representative (if applicable), must be capable of understanding the purpose of the Study and have signed a written informed consent form (ICF) prior to beginning specific protocol procedures.
Female or male participants ≥ 18 years of age at the time of signing ICF.
ECOG performance status of 0 or 1.
Minimum life expectancy of ≥ 12 weeks at screening.
Disqualifiers
Participation in another clinical trial, interventional or observational, until the Study's safety visit.
Known leptomeningeal disease or active uncontrolled or symptomatic central nervous system (CNS) metastases as indicated by clinical symptoms, and/or progressive growth are excluded.
Have a concurrent malignancy or malignancy within three years of Study enrollment with the exception of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.
Known allergy or hypersensitivity reaction to any investigational medicinal product(s) (IMP[s]) or its (their) incorporated substances.
Trial design
Treatments tested in this trial
- Sacituzumab Govitecan (SG)
- Atropine
- G-CSF (Granulocyte colony-stimulating factor)
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov