NCT07367178

Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer

Phase II Study to Improve Sacituzumab Govitecan Tolerance With Atropine in Patients With Advanced Triple-Negative and Hormone Receptor-Positive/HER2-Negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

After signing the informed consent form (ICF) and confirmation of eligibility, participants with mTNBC or mHR(+)/HER2(-) breast cancer will receive sacituzumab govitecan administered as intravenous infusion (IV) at dose of 10 mg/kg on D1 and D8 of each 21-day cycle until unacceptable toxicity, disease progression, withdrawal of consent, death, or study termination, whichever occurs first. Atropine will be administered 0.5 mg SC as premedication 10 minutes before each infusion of sacituzumab govitecan on D1 and D8 of each 21-day cycle during the first two treatment cycles (consider extending to the next cycles at the discretion of the physician). To improve hematologic tolerability, G-CSF will be used as a supportive medication during the first 2 cycles of sacituzumab govitecan. The use of G-CSF beyond the second treatment cycle will be at the discretion of the Investigator.

Conditions

• Breast Cancer
• Advanced HR+/HER2- Breast Cancer
• Advanced Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan (SG)	Participants 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.
DRUG	Atropine	Participants 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.
DRUG	G-CSF (Granulocyte colony-stimulating factor)	All 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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-06-01
• Completion: 2028-01-01
• First posted: 2026-01-26
• Last updated: 2026-01-28