Triple Negative Breast CancerPhase 2PRIMEDNCT05520723
Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED
A Phase 2 study testing Sacituzumab govitecan, Loperamide and Granulocyte Colony-Stimulating Factor in people with Triple Negative Breast Cancer and Breast Cancer, run by MedSIR at 10 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Breast Cancer, Advanced HR+/HER2- Breast Cancer
- What is being tested?
- Sacituzumab govitecan, Loperamide and Granulocyte Colony-Stimulating Factor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesSpain
- Study dates
- 6 Feb 2023to 5 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- 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).
- 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).
- Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use institution specified method(s) of contraception.
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Universitario A Coruña
A Coruña, A Coruna
Hospital de Sant Joan Despí - Moises Broggi
Barcelona
Hospital Universitario Clínico San Cecilio de Granada
Granada
Hospital Arnau de Vilanova
Lleida, Lleida
Hospital Quiron San Camilo- Ruber Juan Bravo
Madrid, Madrid, 28006
Hospital Ramón y Cajal
Madrid
Hospital Universitario Donostia
San Sebastián, Donostia, 20014
Hospital Universitario General de Catalunya
Sant Cugat del Vallès, Barcelona, 08190
Hospital Universitario Virgen del Rocio
Seville
Hospital Quirón Valencia
Valencia, Valencia
About this study
Official title: 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.
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.
Read the 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.
- Being tested
- Sacituzumab govitecan, Loperamide, Granulocyte Colony-Stimulating Factor
- Keywords
- Advanced TNBC, Sacituzumab govitecan, Tolerance, Prophylaxis, Advanced HR+/HER2-
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecanDrug
Also called Trodelvy
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.
LoperamideDrug
Also called Imodium
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).
Granulocyte Colony-Stimulating FactorDrug
Also called Filgrastim, Neupogen
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Sacituzumab govitecan; Drug: Loperamide; Drug: Granulocyte Colony-Stimulating Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline up to end of 2nd cycle (day 42)
Secondary outcomes (11)
Incidence of all grades and grade ≥3 diarrhea.
Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3.
Measured: Until EoS (26 months after study initiation)
Incidence of all grades and grade ≥3 neutropenia.
Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3.
Measured: Until EoS (26 months after study initiation)
Incidence of febrile neutropenia and additional adverse events (AEs) as per NCI-CTCAE v.5.0.
Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3.
Measured: Until EoS (26 months after study initiation)
Discontinuation rate
The discontinuation rate is defined as the proportion of participants discontinued to any cause relative to the number of patients in the analysis set. The reasons for study discontinuation and the period from the treatment initiation to the time of discontinuation will be also reported.
Measured: Until EoS (26 months after study initiation)
Dose reduction rate
The dose reduction rate is defined as the proportion of participants with dose reduction relative to the number of patients in the analysis set. The reasons for dose reduction and the period from the treatment initiation to the time of the first dose reduction will be also reported.
Measured: Until EoS (26 months after study initiation)
Objective response rate (ORR)
Objective response rate is defined as the proportion of participants with complete response or partial response relative to the number of patients in the analysis set. It will be also calculated only for patients with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication, who died, progressed, or dropped out for any reason prior to reaching an objective response will be counted as non-responders in the assessment of ORR. Tumor response will be defined as best response based on local investigator's assessment according to RECIST v1.1.
Measured: Until EoS (26 months after study initiation)
Clinical benefit rate (CBR)
Clinical benefit rate is defined as the proportion of participants with objective response, or stable disease ≥24 weeks relative to the number of patients in the analysis set. Non-complete response/non-progressive disease will be considered as stable disease. Clinical benefit will be also calculated only for patients with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication, who died, progressed, or dropped out for any reason prior to reaching an objective response, or stable disease ≥24 weeks will be counted as without clinical benefit. Tumor response will be defined as best response based on local investigator's assessment according to RECIST v1.1 (Appendix 2).
Measured: Until EoS (26 months after study initiation)
Duration of response (DoR)
Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of disease progression, death due to any cause or treatment discontinuation, whichever occurs first. Duration of response will be calculated in patients with objective response as [the date response ended (i.e., date of PD, death or discontinuation) - first objective response date +1)]/30.4.
Measured: Until EoS (26 months after study initiation)
Time to response (TtR)
Time to response is defined as the period from the treatment initiation to time of the first objective tumor response (tumor shrinkage of ≥30%) observed for patients who achieved an objective response, as determined locally by the investigator through the use of RECIST v.1.1. The length of time to response will be calculated in patients with objective response as [(Objective response or censor date) - treatment initiation date +1]/30.4.
Measured: Until EoS (26 months after study initiation)
Best percentage of change from baseline in the size of target tumor lesions.
Best percentage of change from baseline in the size of target tumor lesions, defined as the biggest decrease, or smallest increase if no decrease will be observed, as determined locally by the investigator using RECIST v.1.1. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication, who died, progressed, or dropped out for any reason prior to reaching an objective response, or stable disease ≥24 weeks will be counted as not available. The analysis will be performed on patients with measurable disease at baseline.
Measured: Until EoS (26 months after study initiation)
Progression free survival (PFS)
Progression-free survival is defined as the period from the date of treatment initiation to the date of the first documentation of objective progressive disease determined locally by investigator or death due to any cause in absence of documented progressive disease. Participants lacking an evaluation of tumor response after treatment initiation will have their progression-free survival time censored on the date of treatment initiation with the duration of a day. The length of progression-free survival will be calculated as [(progression, death date or censor date) - treatment initiation date +1]/30.4. Progression will be determined locally by the investigator using RECIST v.1.1. Objective PD is defined as 20% increase in the sum of diameters of target lesions above the smallest sum observed. The sum must also demonstrate and absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions or the appearance of new lesion.
Measured: Until EoS (26 months after study initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start6 Feb 2023
- Primary completion18 Oct 2023
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520723
- Sponsor's protocol ID
- MEDOPP445
- Other IDs
- 2022-001397-61
- Acronym
- PRIMED
- Status last verified
- Nov 2025
- First submitted
- 19 Jul 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05520723
- Acronym / sponsor ID
- PRIMED / MEDOPP445
- Keywords
- Advanced TNBC, Sacituzumab govitecan, Tolerance, Prophylaxis, Advanced HR+/HER2-
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan + Loperamide + G-CSF | Experimental | Drug: Sacituzumab govitecan, Drug: Loperamide, Drug: Granulocyte Colony-Stimulating FactorUpon 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab govitecanAlso: TrodelvyUpon 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 | Sacituzumab Govitecan + Loperamide + G-CSF |
| LoperamideAlso: ImodiumLoperamide : 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 | Sacituzumab Govitecan + Loperamide + G-CSF |
| Granulocyte Colony-Stimulating FactorAlso: Filgrastim, NeupogenG-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 + Loperamide + G-CSF |
Primary outcome
Incidence of grade ≥2 diarrhea
Time frame: Baseline up to end of 2nd cycle (day 42)
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.
Incidence of grade ≥3 neutropenia
Time frame: Baseline up to end of 2nd cycle (day 42)
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.
11 secondary outcomes
Incidence of all grades and grade ≥3 diarrhea.
Time frame: Until EoS (26 months after study initiation)
Incidence of all grades and grade ≥3 neutropenia.
Time frame: Until EoS (26 months after study initiation)
Incidence of febrile neutropenia and additional adverse events (AEs) as per NCI-CTCAE v.5.0.
Time frame: Until EoS (26 months after study initiation)
Discontinuation rate
Time frame: Until EoS (26 months after study initiation)
Dose reduction rate
Time frame: Until EoS (26 months after study initiation)
Objective response rate (ORR)
Time frame: Until EoS (26 months after study initiation)
Clinical benefit rate (CBR)
Time frame: Until EoS (26 months after study initiation)
Duration of response (DoR)
Time frame: Until EoS (26 months after study initiation)
Time to response (TtR)
Time frame: Until EoS (26 months after study initiation)
Best percentage of change from baseline in the size of target tumor lesions.
Time frame: Until EoS (26 months after study initiation)
Progression free survival (PFS)
Time frame: Until EoS (26 months after study initiation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab govitecan, Loperamide and Granulocyte Colony-Stimulating Factor in people with Triple Negative Breast Cancer and Breast Cancer, run by MedSIR at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥2 diarrhea (time frame: Baseline up to end of 2nd cycle (day 42)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.