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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sacituzumab Govitecan (SG)
DrugParticipants will receive sacituzumab govitecan at a dose of 10 mg/kg body weight, administered via intravenous (IV) infusion on Day 1 and Day 8 of each 21-day cycle until unacceptable toxicity, disease progression, death, discontinuation from the Study treatment for any other reason or End of the Study (EoS), whichever occurs first.
Atropine
DrugParticipants will receive atropine at a dose of 0.5 mg as premedication 10 minutes before prior to each sacituzumab govitecan infusion during the first two treatment cycles. Continuation of atropine beyond Cycle 2 will be at the discretion of the Investigator.
G-CSF (Granulocyte colony-stimulating factor)
DrugAll participants will receive 0.5MU/kg/day of G-CSF, according to the participant's weight, which will be administered subcutaneously (SC), once a day during two consecutive days, 48 hours after administration of sacituzumab govitecan (D3, D4 and D10, D11) during the first two cycles. The use of G-CSF beyond the second treatment cycle will be at the discretion of the Investigator.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Sacituzumab govitecan + Atropine + G-CSFExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
To assess the incidence and severity of diarrhea during the first two treatment cycles
Incidence of grade ≥2 diarrhea during the first two treatment cycles as assessed by the Investigator, with severity determined by the NCI-CTCAE v.6.0.
Time frame
Baseline up to end of 2nd cycle (day 42)Secondary outcomes
1
To assess the incidence and severity of constipation during the first two treatment cycles
Incidence of all grades constipation during the first two treatment cycles, as assessed by the Investigator, with severity determined by the NCI-CTCAE v.6.0.
Time frame
Baseline up to end of 2nd cycle (day 42)2
To determine the overall safety profile during the first two treatment cycles and the extended follow-up.
Overall safety profile according to the NCI-CTCAE v.6.0 during the first two treatment cycles and the extended follow-up
Time frame
Until EoS (9 months after last participant is included in the Study unless premature termination of the Study)3
To evaluate the incidence and severity of diarrhea during the first two treatment cycles versus 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.6.0.
Time frame
Until EoS (9 months after last participant is included in the Study unless premature termination of the Study)4
To evaluate the incidence and severity of constipation during the first two treatment cycles versus extended follow-up.
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.6.0.
Time frame
Until EoS (9 months after last participant is included in the Study unless premature termination of the Study)Locations
Source ClinicalTrials.gov
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