NCT05520723

Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED

Multicenter, Open-label, Single Arm, Phase II Clinical Trial to Improve Sacituzumab Govitecan's Tolerance in Patients With Metastatic Triple-Negative or Luminal Breast Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial that is designed to improve the tolerance of sacituzumab govitecan in patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) or Luminal breast cancer, refractory to at least one, and no more than two, prior standard of care chemotherapy regimens in this setting that is not amenable to resection with curative intent. The goal of this study is to evaluate the safety of sacituzumab govitecan in combination with loperamide and G-CSF in pretreated patients with unresectable locally advanced or metastatic TNBC or Luminal breast cancer.

Detailed description

The hypothesis of this study is that the prophylactic administration of loperamide (for diarrhea) and G-CSF therapies (for neutropenia) would avoid these undesirable effects when patients are treated with sacituzumab govitecan, thus decreasing the rate of dose reduction or discontinuation, and significantly improving patients' quality of life. The main objectives of this study are: Primary objective: \- To evaluate the incidence of diarrhea and neutropenia in patients with unresectable locally advanced or metastatic TNBC or Luminal breast cancer treated with sacituzumab govitecan in combination with loperamide and G-CSF. Secondary objectives: * To determine the safety and tolerability of the study regimen in this patient population. * To determine the efficacy of the study regimen in this patient population.

Conditions

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

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan	Upon meeting all selection criteria, patients enrolled in the single-arm study will receive the combination of: sacituzumab govitecan and prophylaxis (loperamide and G-CSF). Sacituzumab govitecan :10 mg/kg, intravenously (IV) on Days 1 and 8 every 21-day cycle . This treatment will continue until disease progression, unacceptable toxicity, or physician's/patient's decision.
DRUG	Loperamide	Loperamide : 2 mg orally (PO), twice a day (BID), or 4 mg once a day (QD) during three consecutive days after administration of sacituzumab govitecan, (D2, D3, D4 and D9, D10, D11) during the first two cycles (consider extending to the next cycle at the discretion of the physician).
DRUG	Granulocyte Colony-Stimulating Factor	G-CSF : 30 MU subcutaneously (SC) QD during two consecutive days, 48 hours after administration of sacituzumab govitecan (D3, D4 and D10, D11) during the first two cycles (consider extending to the next cycle at the discretion of the physician).

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-10-18
• Completion: 2025-11-05
• First posted: 2022-08-30
• Last updated: 2025-12-04

Locations

10 sites across 1 country: Spain