This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer.
The goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?
Patient must have signed a written informed consent prior to any trial specific procedures. (Note : When the patient is physically unable to give his/her written consent, a impartial witness of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent)
Men or women ≥ 18 years of age
Patient eligible to receive sacituzumab-govitecan and T-Dxd according to their indication
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Patient previously treated with any ADC targeting HER2 or TROP2
Patient with uncontrolled or significant cardiovascular disease
Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline/screening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment
History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Parallel
Sacituzumab Govitecan / Trastuzumab Deruxtecan
DrugSacituzumab govitecan is administered intravenously at a dose of 10 mg/kg on Day 1 and Day 8 of each 3-week cycle. In this study, patients receive two cycles of sacituzumab govitecan followed by two cycles of trastuzumab deruxtecan, alternating throughout the study. Trastuzumab deruxtecan is administered intravenously at a dose of 5.4 mg/kg on Day 1 of each 3-week cycle. In this study, patients receive two cycles of trastuzumab deruxtecan followed by two cycles of sacituzumab govitecan, alternating throughout the study. Both Treatment are continued until disease progression as defined by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or the end of the study.
Overall survival (OS)
The overall survival is the length of time from randomization that patients enrolled in the study are still alive
Clinical Benefit Rate (CBR)
Clinical Benefit Rate is defined as the percentage of patients with complete response (CR), partial response (PR), or stable disease (SD)for at least 24 weeks, as assessed by RECIST 1.1
Objective response rate (ORR)
The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) as assessed by RECIST 1.1
Progression-free survival (PFS),
The progression-free survival is 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.
Quality-Adjusted progression free survival (QA-PFS)
Quality-Adjusted progression free survival is calculated as the product of the progression free survival function and the overall health utility index EQ-5D-5L.
This trial is not recruiting at the moment. You can still explore other options:
