Evaluating the effectiveness of sacituzumab govitecan for metastatic triple-negative breast cancer
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
This study is testing how well a new treatment called sacituzumab govitecan works for people with metastatic triple-negative breast cancer and whether it is safe to use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | sacituzumab |
| Locations | 1 site (Rome) |
| Trial ID | NCT06240195 on ClinicalTrials.gov |
What this trial studies
This observational, prospective, multicenter study aims to collect data on the effectiveness and tolerability of sacituzumab govitecan in patients with metastatic triple-negative breast cancer (mTNBC). The study will evaluate histological and biomolecular characteristics of tumor samples from both primary and metastatic sites, as well as circulating plasma. Biomarkers predictive of treatment efficacy and tolerability will be identified through analysis of tumor tissue and plasma collected at two time points. Additionally, the feasibility of developing organoids and conducting single-cell sequencing will be assessed in a small subgroup of patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histological diagnosis of locally advanced unresectable or metastatic triple-negative breast cancer who are indicated for treatment with sacituzumab govitecan.
Not a fit: Patients with a history of other malignancies or contraindications to sacituzumab govitecan, as well as those with untreated or clinically unstable brain metastases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of sacituzumab govitecan and identify biomarkers that predict patient response, potentially improving treatment strategies for mTNBC.
How similar studies have performed: Other studies have shown promise in evaluating treatment efficacy and biomarkers in similar patient populations, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with a history of other malignancies; * Contraindications to the use of sacituzumab govitecan SG; * Untreated and/or clinically unstable (symptomatic) brain metastases.
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Patrizia Vici, Doctor — IRCCS "Regina Elena" National Cancer Institute
- Study coordinator: Patrizia Vici, Doctor
- Email: patrizia.vici@ifo.it
- Phone: 06-5266.5584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.