Biomarkers of Efficacy and Tolerability of Sacituzumab-Govitecan in the Treatment of Patients With Triple-negative Breast Cancer in the Metastatic Phase: Prospective Multicenter Real-world Study

Обзор

Observational, prospective, multicenter study. Collection of data relating to the effectiveness of sacituzumab govitecan SG, in a real-world context and planned research of predictive biomarkers of efficacy/tolerability carried out on multiple platforms at the center coordinator.

Подробное описание

Identification and inclusion in the study of patients affected by metastatic triple-negative breast cancer mTNBC, treated with sacituzumab govitecan SG as indicated at the participating centers.

Histological and biomolecular characteristics will be evaluated both on the tumor at diagnosis and on tissue resulting from biopsy of the metastatic site, where available. Otherwise, the analyzes will come anyway carried out on the most recent and available tumor tissue, whether deriving from primary tumor or site metastatic.

The search for biomarkers predictive of efficacy/tolerability will be carried out on tumor tissue (where possible both primary and metastatic) and on circulating plasma collected at two separate time points (T0 and T1).

Biomolecular characterization on the biological material of the enrolled patients (tumor tissue and plasma) will be carried out at the end of the study.

The feasibility of organoid development and single-cell sequencing will be evaluated on a small subgroup of patients, among those enrolled at the coordinating center, considering the need for tumor tissue prepared fresh for both methods.

Вмешательства

• Другое data collection
  Collection of data relating to the effectiveness of sacituzumab govitecan and evaluation in a real-world context and planned research of predictive biomarkers of efficacy/tolerability

Первичные конечные точки

• Biomolecular investigations conducted on multiple platforms [Срок оценки: 30 months]

Вторичные конечные точки (3)

• PFS in patients. [Срок оценки: 30 months]
• Tolerability of the treatment [Срок оценки: 30 months]
• Development of organoids [Срок оценки: 30 months]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Histological diagnosis of TNBC;
• Locally advanced unresectable or metastatic disease;
• Indication for treatment with SG in monotherapy according to clinical practice (patients pre-treated with at least two lines of systemic therapy, of which at least one in an advanced stage);
• Availability of at least one tumor tissue sample (from primary tumor or metastasis) to be sent to the coordinating center (IRE);
• Written informed consent;
• Availability to comply with the procedures established by the protocol, according to the methods and times described.

Критерии исключения

• Patients with a history of other malignancies;
• Contraindications to the use of sacituzumab govitecan SG;
• Untreated and/or clinically unstable (symptomatic) brain metastases.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Италия · 1 центр

• "Regina Elena" National Cancer Institute — Rome

Идентификаторы

NCT: NCT06240195 · RS1814/22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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