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

NCT05520723 | Completed Phase 2 DMC

• 2 other identifiers: MEDOPP4452022-001397-61
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

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

Keywords

Advanced TNBC; Sacituzumab govitecan; Tolerance; Prophylaxis; Advanced HR+/HER2-

Outcome Measures

Primary Outcomes (2)

• Incidence of grade ≥2 diarrhea

  The rate of patients with grade ≥ 2 diarrhea is defined as the number of patients with diarrhea grade 2 to 5 the first 2 cycles of treatment by the number of patients in the analysis set per 100. The adverse events will be assessed by the Investigator and with severity determined using defined and graded according CTCAE v.5.0. The adverse events without the severity grade reported will be considered as grade 3.

  Baseline up to end of 2nd cycle (day 42)

• Incidence of grade ≥3 neutropenia

  The rate of patients with grade ≥ 3 neutropenia is defined as the number of patients with neutropenia grade 3 to 5 the first 2 cycles of treatment by the number of patients in the analysis set per 100. The adverse events will be assessed by the Investigator and with severity determined using defined and graded according CTCAE v.5.0. The adverse events without the severity grade reported will be considered as grade 3.

  Baseline up to end of 2nd cycle (day 42)

Secondary Outcomes (11)

• Incidence of all grades and grade ≥3 diarrhea.

  Until EoS (26 months after study initiation)

• Incidence of all grades and grade ≥3 neutropenia.

  Until EoS (26 months after study initiation)

• Incidence of febrile neutropenia and additional adverse events (AEs) as per NCI-CTCAE v.5.0.

  Until EoS (26 months after study initiation)

• Discontinuation rate

  Until EoS (26 months after study initiation)

• Dose reduction rate

  Until EoS (26 months after study initiation)

Study Arms (1)

Sacituzumab Govitecan + Loperamide + G-CSF

EXPERIMENTAL

Upon meeting all selection criteria, patients enrolled in the study will receive the combination of: 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. 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). 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).

Drug: Sacituzumab govitecan; Drug: Loperamide; Drug: Granulocyte Colony-Stimulating Factor

Interventions

Sacituzumab govitecan DRUG

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.

Also known as: Trodelvy

Sacituzumab Govitecan + Loperamide + G-CSF

Loperamide DRUG

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).

Also known as: Imodium

Sacituzumab Govitecan + Loperamide + G-CSF

Granulocyte Colony-Stimulating Factor DRUG

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).

Also known as: Filgrastim, Neupogen

Sacituzumab Govitecan + Loperamide + G-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form (ICF) prior to participation in any study-related activities.
• Patients aged ≥18 years at the time of signing ICF.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of ≥ 12 weeks.
• Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
• All patients must have been previously treated with taxanes regardless of disease stage (adjuvant, neoadjuvant, or advanced), unless contraindicated for a given patient.
• Refractory to at least one, and no more than two, prior standard of care chemotherapy regimens for unresectable locally advanced or MBC. Earlier adjuvant or neoadjuvant therapy for more limited disease will be considered as one of the required prior regimens if the development of unresectable locally advanced or metastatic disease occurred within a 12-month period after completion of chemotherapy or immunotherapy (e.g., adjuvant pembrolizumab).
• For TNBC patient only:
• a.) Histologically confirmed TNBC per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) criteria based on local testing on the most recent analyzed biopsy. Triple-negative is defined as \<1% expression for estrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2) (0-1+ by IHC or 2+ and negative by in situ hybridization \[ISH) test\].
• For HR positive luminal breast cancer patients only:
• Confirmed diagnosis of estrogen receptor (ER)\[+\] and/or progesterone receptor (PR)\[+\] (with ≥1% positive stained cells according to National Comprehensive Cancer Network \[NCCN\] and American Society of Clinical Oncology \[ASCO\] guidelines) and human epidermal growth factor receptor 2 (HER2)- negative (0 or 1+ by immunohistochemistry \[IHC\] or 2+ and negative by in situ hybridization \[ISH\] test) breast cancer in the advanced setting.
• Refractory to at least 1 prior anticancer hormonal treatment and at least 1 CDKi4/6 in the metastatic setting.
• Measurable or non-measurable, but evaluable disease, as per RECIST v.1.1. Patients with bone-only metastases are also eligible.
• Brain MRI must be done for patients with suspicion of brain metastases and patient must have stable central nervous system (CNS) disease for at least 4 weeks after local therapy, without neurological symptoms, and off anticonvulsants and steroids for at least 2 weeks before first dose of study treatment.
• Adequate hematologic counts without transfusional or growth factor support within 2 weeks before of study drug initiation (hemoglobin ≥ 9 g/dL, ANC ≥ 1500/mm3, and platelets ≥ 100,000/μL).

You may not qualify if:

• Prior treatment with topoisomerase 1 inhibitors as a free form or as other formulations.
• Patients with carcinomatous meningitis or leptomeningeal disease.
• Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.
• Patients with Gilbert's disease.
• Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
• Participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval.
• Known history of unstable angina, myocardial infarction, or cardiac heart failure present within 6 months of study initiation or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or history of QT interval prolongation.
• Known history of clinically significant active Chronic obstructive pulmonary disease (COPD), or other moderate-to-severe chronic respiratory illness present within 6 months of study initiation.
• Known history of clinically significant bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of study initiation.
• Active or prior documented inflammatory bowel disease (i.e. Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade ≥1 diarrhea).
• Infection requiring antibiotic use within 1 week of randomization.
• Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
• Women who are pregnant or lactating.
• Concomitant participation in other interventional clinical trial. Note: Patients participating in observational studies are eligible.

Sponsors & Collaborators

• MedSIR: lead
• Gilead Sciences: collaborator

Study Sites (10)

Hospital Universitario A Coruña

A Coruña, A Coruna, Spain

Location

Hospital Universitario General de Catalunya

Sant Cugat del Vallès, Barcelona, 08190, Spain

Location

Hospital Universitario Donostia

San Sebastián, Donostia, 20014, Spain

Location

Hospital Arnau de Vilanova

Lleida, Lleida, Spain

Location

Hospital Quiron San Camilo- Ruber Juan Bravo

Madrid, Madrid, 28006, Spain

Location

Hospital Quirón Valencia

Valencia, Valencia, Spain

Location

Hospital de Sant Joan Despí - Moises Broggi

Barcelona, Spain

Location

Hospital Universitario Clínico San Cecilio de Granada

Granada, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

sacituzumab govitecan; Loperamide; Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open label, single-arm
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 30, 2022
• Study Start: February 6, 2023
• Primary Completion: October 18, 2023
• Study Completion: November 5, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

ES (10)