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

NCT05552001 | Recruiting Phase 3 DMC

• 2 other identifiers: UC-BCG-22042022-502369-10-00
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Triple Negative Breast Cancer; Metastatic Breast Cancer

Keywords

breast cancer; metastatic; triple negative; sacituzumab govitecan; biomarker analysis

Outcome Measures

Primary Outcomes (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

  From inclusion to disease progression, up to 6 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

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

• Duration of response (DOR)

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

• Clinical benefice risk (CBR)

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

• Overall Survival (OS)

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

• The incidence of adverse events (Safety)

  Throughout study completion, up to 36 months

Study Arms (1)

Single arm receiving sacituzumab govitecan

EXPERIMENTAL

Drug: Sacituzumab govitecan

Interventions

Sacituzumab govitecan DRUG

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.

Also known as: trodelvy

Single arm receiving sacituzumab govitecan

Eligibility Criteria

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

You may qualify if:

• 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
• 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 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;

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• UNICANCER: lead
• Gilead Sciences: collaborator

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms; Neoplasm Metastasis

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbara Pistilli, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara GUYONNEAU, PharmD

CONTACT

0685167111; c-guyonneau@unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: October 5, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 6, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

FR (1)