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Safety and efficacy analysis of an antibody associated with a chemotherapy for patients with a triple negative metastatic breast cancer.
EU CTIS ID: 2022-502369-10-00
What this study is testing
To evaluate the efficacy of sacituzumab govitecan via investigator-assessed objective response rate (ORR) according to RECIST v1.1, in patients with mTNBC or inoperable locally ABC whose disease has progressed on (neo)adjuvant chemotherapy for early TNBC or within 6 months after the end of curative treatments (any systemic or local treatment with curative intent, whatever comes last).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient must have signed a written informed consent prior to any trial specific procedures; Note; When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
- Adequate haematologic and organ function: Hematologic counts : Hemoglobin ≥9 g/dL, Absolute neutrophil count ≥1500/mm3 or ≥1.5 x 109/L Platelets ≥100,000/μL (without transfusional or growth factor support within 2 weeks of study drug initiation) Serum creatinine (SCr) ; Creatinine clearance (CrCl) ≥30 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl; Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) : AST and ALT ≤ 2.5 ULN or ≤ 5 ULN if known liver metastases; Total bilirubin : ≤1.5 × upper limit of normal (ULN) if no liver metastases (<3 × ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline); Serum albumin : >3 g/dL
- 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 of 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);
You likely can't join if
- Participation in another therapeutic trial within the 30 days prior to C1D1;
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- 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);
- Met any of the following criteria for cardiac disease: a) Myocardial infarction or unstable angina pectoris within 6 months of enrolment. b) 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. c) 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;
See the full eligibility criteria
Who can join
- Patient must have signed a written informed consent prior to any trial specific procedures; Note; When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent
- Adequate haematologic and organ function: Hematologic counts : Hemoglobin ≥9 g/dL, Absolute neutrophil count ≥1500/mm3 or ≥1.5 x 109/L Platelets ≥100,000/μL (without transfusional or growth factor support within 2 weeks of study drug initiation) Serum creatinine (SCr) ; Creatinine clearance (CrCl) ≥30 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl; Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) : AST and ALT ≤ 2.5 ULN or ≤ 5 ULN if known liver metastases; Total bilirubin : ≤1.5 × upper limit of normal (ULN) if no liver metastases (<3 × ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline); Serum albumin : >3 g/dL
- 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 of 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;
- 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.
- Prior exposure to a taxane in localized or advanced/metastatic setting; 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 biopsie. 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 on treatment biopsy. 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;
What rules you out
- Participation in another therapeutic trial within the 30 days prior to C1D1;
- Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- 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);
- Met any of the following criteria for cardiac disease: a) Myocardial infarction or unstable angina pectoris within 6 months of enrolment. b) 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. c) 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;
- Prior treatment with topoisomerase-1 inhibitor or with ADC containing topoisomerase-1 inhibitor
- 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
- Requirement for ongoing therapy with medications that are prohibited or to be used with caution
- 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;
- Known COVID-19 infection at screening;
- Evidence of significant uncontrolled concomitant disease;
- 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;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.