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Triple Negative Breast CancerPhase 3ISIdENCT05552001

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

A Phase 3 study testing Sacituzumab govitecan in people with Triple Negative Breast Cancer and Metastatic Breast Cancer, run by UNICANCER at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to: 1. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab govitecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteFrance
Study dates
5 Oct 2023to 6 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Patient must have signed a written informed consent prior to any trial specific procedures;
  • Note: When the patient is unable to write to give his written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent
  • Male or female ≥ 18 years of age;
  • Patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed on (neo)adjuvant chemotherapy+/-immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with curative intent, whatever comes last.
  • Note: TNBC is defined as the absence of HER2 overexpression by immunohistochemistry (IHC) defined as IHC 0, 1+, or 2+ and fluorescence in situ hybridization [FISH] non-amplified and estrogen receptor (ER) expression <10% and progesterone receptor (PR) expression <10% by local pathological assessment on the most recent tissue sample collected
  • Prior exposure to a taxane
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  • Note: If indicated, prior therapy with ICI for patients with PD1 positive tumor and prior treatment with PARP inhibitor for patients with gBRCAm is required
  • Measurable disease, as defined by RECIST v1.1
  • Patient must have accepted to perform on-treatment biopsies. If the physician considers doing the biopsy on the primary tumor site because accessibility, it can be performed only if the primary tumor site has not been previously irradiated;
  • Have metastatic site easily accessible to biopsy (with exception of bone metastasis)
  • Note 1: Patients with only bone metastasis will be eligible if the primary tumor is accessible for biopsy at inclusion
  • Note 2: If the patient has a single measurable lesion and it is the only one that can be biopsied, the patient cannot be included because the disease is no longer measurable according to RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
  • Life expectancy ≥12 weeks;
  • Adequate haematologic and organ function
  • Negative hepatitis B surface antigen (HBsAg) test at screening (patients with a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening are eligible), negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening;
  • Evidence of post-menopausal status or negative pregnancy urinary test within 72 hours or serum pregnancy test within 14 days before study treatment and confirmed prior to treatment on Cycle 1 Day 1 for female pre-menopausal patients;
  • Woman of childbearing potential and male patient must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment for women and up to 3 months for men;
  • Patient affiliated to a social security system (or equivalent);
  • Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up;

Who cannot join

  • Participation in another therapeutic trial within the 30 days prior to C1D1;
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases or evidence of leptomeningeal disease or clinically active spinal cord compression. Patients with stable and asymptomatic brain metastases will be eligible, yet the number will be capped to 15% of the overall population;
  • Previous history of cancer other than mTNBC within 5 years prior to C1D1, except of those with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%) and treated with curative intent (e.g. carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer);
  • Prior treatment with topoisomerase-1 inhibitor or with ADC containing topoisomerase-1 inhibitor
  • Met any of the following criteria for cardiac disease:
  • Myocardial infarction or unstable angina pectoris within 6 months of enrolment.
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  • History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
  • New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of <40%.
  • Severe uncontrolled infection requiring oral or IV antibiotics within 4 weeks prior to C1D1;
  • Major surgical procedure within 4 weeks prior to C1D1;
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to humanized antibodies;
  • Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
  • Patients receiving concomitant anti-cancer treatments such as chemotherapy, immunotherapy, endocrine therapy and radiotherapy;
  • Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved according to the common terminology criteria for adverse events of the National Cancer Institute (NCI-CTCAE) v5.0 grade >2
  • Treatment with systemic corticosteroids dosed at >20 mg prednisone or equivalent or other systemic immunosuppressive medications within 2 weeks prior to C1D1;
  • Known history of testing positive for HIV or known acquired immunodeficiency syndrome if not controlled;
  • Evidence of significant uncontrolled concomitant disease;
  • Requirement for ongoing therapy with medications that are prohibited or to be used with caution
  • Individuals with physical or psychological conditions considered not to be compatible with the trial;
  • Persons deprived of their liberty or under protective custody or guardianship;
  • Pregnant or breastfeeding women;
  • Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: ISIdE: Open Label, Multicentric, Single-arm Phase IIIB Trial to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Triple Negative Metastatic Breast Cancer Patients With a Biomarker Analysis

ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to:

  1. evaluate the treatment efficacy in less pretreated patients.
  2. identify biomarkers that could predict response or resistance to the drug.
Read the detailed description

ISIDE is a European, multicenter, open label, single-arm phase IIIB trial that aims to include 38 patients with pathologically documented locally advanced inoperable or metastatic triple negative breast cancer (mTNBC) whose disease has progressed on (neo)adjuvant chemotherapy with or without immunotherapy for early TNBC or within 6 months after the end of any systemic therapy, surgery or radiotherapy with curative intent, whatever comes last.

The primary objective is to to evaluate the efficacy of sacituzumab govitecan via investigator-assessed objective response rate (ORR) according to RECIST v1.1.

Patient will receive SG until disease progression, unacceptable toxicity, or decision to withdraw its participation.

Being tested
Sacituzumab govitecan
Keywords
breast cancer, metastatic, triple negative, sacituzumab govitecan, biomarker analysis
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab govitecanDrug

    Also called trodelvy

    Sacituzumab Govitecan (SG) is given by intervenous route, 10 mg/kg on day 1 and day 8 of 21-day treatment cycles. Patient will receive treatment until disease progression, unacceptable toxicity, or decision to withdraw its participation.

Study groups in NCT05552001
Study groupRoleWhat they receive
Single arm receiving sacituzumab govitecanExperimentalNot described
Receives: Drug: Sacituzumab govitecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    ORR is defined as the number of patient with at least a confirmed complete response (CR) or partial response (PR), based on the best objective response values while on treatment

    Measured: From inclusion to disease progression, up to 6 months

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    PFS iis the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

    Measured: From inclusion to disease progression or death, up to 2 years

  2. Duration of response (DOR)

    DOR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression or death due to any cause

    Measured: From inclusion to disease progression or death, up to 2 years

  3. Clinical benefice risk (CBR)

    CBR is defined as the presence of at least a PR or CR, or a stable disease (SD) while on treatment

    Measured: From inclusion to disease progression or death, up to 2 years

  4. Overall Survival (OS)

    The overall survival is the length of time from randomization that patients enrolled in the study are still alive.

    Measured: From inclusion to disease progression or death, up to 2 years

  5. The incidence of adverse events (Safety)

    Safety and tolerability of sacituzumab govitecan will be evaluated using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5). NCI-CTCAE is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout study completion, up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start5 Oct 2023
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion6 May 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552001
Sponsor's protocol ID
UC-BCG-2204
Other IDs
2022-502369-10-00
Acronym
ISIdE
Status last verified
Jul 2026
First submitted
20 Sep 2022
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab govitecan in people with Triple Negative Breast Cancer and Metastatic Breast Cancer, run by UNICANCER at 1 site in France.

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 22 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Objective response rate (ORR) (time frame: From inclusion to disease progression, up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05552001.

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 21 Jul 2026.

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