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

NCT06240195 | Recruiting

• 1 other identifier: RS1814/22
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Biomolecular investigations conducted on multiple platforms

  Identify the predictive factors of the efficacy of sacituzumab govitecan in terms of PFS through biomolecular investigations conducted on multiple platforms, using tumor tissue (where possible both primary and metastatic) and peripheral blood, circulating plasma collected at two separate time points (T0 and T1) of mTNBC patients treated in the real-world setting.

  30 months

Secondary Outcomes (3)

• PFS in patients.

  30 months

• Tolerability of the treatment

  30 months

• Development of organoids

  30 months

Study Arms (1)

patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan

The availability of at least one tumor tissue sample to be transferred to the coordinating center will be essential for enrollment in the study. For patients for whom a new sampling is scheduled biopsy of the tumor (primary or metastasis) as per clinical practice, the feasibility of the development will be assessed tumor organoids and the execution of single-cell sequencing on tumor tissue. In these cases, the order of priority in dividing the sampled tissue will be: sufficient quota to carry out the histological examination that will have to be carried out naturally confirm the diagnosis of triple-negative breast cancer. Quota to be prepared as a fresh preparation for the two experiments of feasibility indicated above; quota to be considered as a second sample, to be analyzed at the end of the study.

Other: data collection

Interventions

data collection OTHER

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

patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic triple-negative breast cancer treated with socituzumab govitecan as indicated, with at least one sample of tumor tissue available.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Ospedale Sandro Pertini, Roma: collaborator
• Catholic University of the Sacred Heart: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Campus Bio-Medico University: collaborator
• Azienda Policlinico Umberto I: collaborator
• San Giovanni Addolorata Hospital: collaborator
• Ospedale "SS Annunziata", Chieti: collaborator
• Ospedale "Gaetano Bernabeo" , Ortona: collaborator
• Hospital San Pietro Fatebenefratelli: collaborator
• presidio Ospedaliero santo spirito in Sassia, Roma: collaborator
• Ospedale di Belcolle - Viterbo: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue (where possible both primary and metastatic) and on circulating plasma collected at two separate time points (T0 and T1).

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Patrizia Vici, Doctor

  IRCCS "Regina Elena" National Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Vici, Doctor

CONTACT

06-5266.5584; patrizia.vici@ifo.it

Eriseld Krasniqi, Doctor

CONTACT

eriseld.krasniqi@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 2, 2024
• Study Start: January 17, 2023
• Primary Completion: January 17, 2025
• Study Completion: June 17, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)