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

NCT07367178 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • MedSIR

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-06-30
Completion
2028-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07367178 on ClinicalTrials.gov