Trial Title:
Preventive stRategy for IMMU132-relatED AEs in TNBC - PRIMED
NCT ID:
NCT05520723
Condition:
Triple Negative Breast Cancer
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Loperamide
Antidiarrheals
Lenograstim
Sacituzumab govitecan
Conditions: Keywords:
Advanced TNBC
Sacituzumab govitecan
Tolerance
Prophylaxis
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open label, single-arm
Intervention:
Intervention type:
Drug
Intervention name:
Sacituzumab govitecan
Description:
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.
Arm group label:
Sacituzumab Govitecan + Loperamide + G-CSF
Other name:
Trodelvy
Intervention type:
Drug
Intervention name:
Loperamide
Description:
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).
Arm group label:
Sacituzumab Govitecan + Loperamide + G-CSF
Other name:
Imodium
Intervention type:
Drug
Intervention name:
Granulocyte Colony-Stimulating Factor
Description:
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).
Arm group label:
Sacituzumab Govitecan + Loperamide + G-CSF
Other name:
Filgrastim
Other name:
Neupogen
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), 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.
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed Informed Consent Form (ICF) prior to participation in any study-related
activities.
2. Patients aged ≥18 years at the time of signing ICF.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 12 weeks.
5. 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.
6. All patients must have been previously treated with taxanes regardless of disease
stage (adjuvant, neoadjuvant, or advanced), unless contraindicated for a given
patient.
7. 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).
8. 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].
9. For HR positive luminal breast cancer patients only:
1. 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.
2. Refractory to at least 1 prior anticancer hormonal treatment and at least 1
CDKi4/6 in the metastatic setting.
10. Measurable or non-measurable, but evaluable disease, as per RECIST v.1.1. Patients
with bone-only metastases are also eligible.
11. 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.
12. 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).
13. Adequate renal and hepatic function (creatinine clearance of ≥ 60 ml/min, may be
calculated using Cockcroft-Gault equation; bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3.0
x ULN or 5 x ULN if known liver metastases).
14. Resolution of all acute AEs of prior anti-cancer therapy to grade 1 as determined by
the NCI-CTCAE v.5.0 (except for alopecia or other toxicities not considered a safety
risk for the patient at investigator discretion).
15. Male patients and female patients of childbearing potential who engage in
heterosexual intercourse must agree to use institution specified method(s) of
contraception.
16. Patients must have completed all prior cancer treatments at least 2 weeks* prior to
randomization including chemotherapy (includes also endocrine treatment),
radiotherapy, and major surgery.
- Prior antibody treatment for cancer must have been completed at least 3 weeks
prior to randomization.
Exclusion Criteria:
1. Prior treatment with topoisomerase 1 inhibitors as a free form or as other
formulations.
2. Patients with carcinomatous meningitis or leptomeningeal disease.
3. Known hypersensitivity reaction to any investigational or therapeutic compound or
their incorporated substances.
4. Patients with Gilbert's disease.
5. Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
6. 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.
7. 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.
8. 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.
9. Known history of clinically significant bleeding, intestinal obstruction, or
gastrointestinal perforation within 6 months of study initiation.
10. 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).
11. Infection requiring antibiotic use within 1 week of randomization.
12. 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.
13. Women who are pregnant or lactating.
14. Concomitant participation in other interventional clinical trial. Note: Patients
participating in observational studies are eligible.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitario General de Catalunya
Address:
City:
Sant Cugat Del Vallès
Zip:
08190
Country:
Spain
Facility:
Name:
Hospital Universitario Donostia
Address:
City:
San Sebastián
Zip:
20014
Country:
Spain
Facility:
Name:
Hospital Universitario A Coruña
Address:
City:
A Coruna
Country:
Spain
Facility:
Name:
Hospital de Sant Joan Despí - Moises Broggi
Address:
City:
Barcelona
Country:
Spain
Facility:
Name:
Hospital Universitario Clínico San Cecilio de Granada
Address:
City:
Granada
Country:
Spain
Facility:
Name:
Hospital Arnau de Vilanova
Address:
City:
Lleida
Country:
Spain
Facility:
Name:
Hospital Quiron San Camilo- Ruber Juan Bravo
Address:
City:
Madrid
Zip:
28006
Country:
Spain
Facility:
Name:
Hospital Ramón y Cajal
Address:
City:
Madrid
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Country:
Spain
Facility:
Name:
Hospital Quirón Valencia
Address:
City:
Valencia
Country:
Spain
Start date:
February 7, 2023
Completion date:
December 14, 2025
Lead sponsor:
Agency:
MedSIR
Agency class:
Other
Collaborator:
Agency:
Gilead Sciences
Agency class:
Industry
Source:
MedSIR
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05520723