Breast CancerBIO-PROSANCT06240195
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
An observational study of Breast Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- data collection
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jan 2023to 17 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic triple-negative breast cancer treated with socituzumab govitecan as indicated, with at least one sample of tumor tissue available.
Who may be able to join
- 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.
Who cannot join
- Patients with a history of other malignancies;
- Contraindications to the use of sacituzumab govitecan SG;
- Untreated and/or clinically unstable (symptomatic) brain metastases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eriseld Krasniqi, Doctor contact
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, Rome, 00144
Patrizia Vici, Doctor, 06-5266.5584 ext. +39, patrizia.vici@ifo.it
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- data collection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
Secondary outcomes (3)
PFS in patients.
Assess any differences in terms of PFS in patients treated in second line compared to patient treated in lines subsequent to the second. Evaluate the dynamics of quantitative variation over time of any circulating microRNAs predictive of efficacy and tolerability. Evaluate the differences in any predictive biomarkers of efficacy/tolerability, tissue and/or circulating, in patients treated in second line vs patients treated in subsequent lines. Assess any differences in PFS in relation to: previous treatment(s) in the early setting and metastatic, disease sites, dose reductions/treatment discontinuation.
Measured: 30 months
Tolerability of the treatment
Evaluate the tolerability of the treatment in terms of adverse events, defined according to Common Terminology Criteria for Adverse Events (CTCAE, v. 5) and identify factors predictive of toxicity. Evaluate objective response rate (ORR) and overall survival (OS). Assess the variation in any biomarkers of efficacy in primary tumor tissue vs. tissue from metastatic localization (in cases where both samples are available). Select a small subgroup of patients from whose tumor tissue to develop organoids will be treated with SG, and on which potential will be quantified longitudinally over time biomarkers of response to treatment.
Measured: 30 months
Development of organoids
Select a small subgroup of patients from the tumor tissue for single cell testing RNA sequencing to compare with data from bulk RNA sequencing to study the microenvironment tumoral.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start17 Jan 2023
- Primary completion17 Jan 2025
- Study completion17 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale Sandro Pertini, Roma, Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Campus Bio-Medico University, Azienda Policlinico Umberto I, San Giovanni Addolorata Hospital, Ospedale "SS Annunziata", Chieti, Ospedale "Gaetano Bernabeo" , Ortona, Hospital San Pietro Fatebenefratelli, presidio Ospedaliero santo spirito in Sassia, Roma, Ospedale di Belcolle - Viterbo
- Responsible party
- Sponsor
- Investigators
- Patrizia Vici, Doctor, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240195
- Sponsor's protocol ID
- RS1814/22
- Acronym
- BIO-PROSA
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Sponsor is the exclusive owner of all data and information arising from the study, including results, discoveries, know-how and the like.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06240195
- Acronym / sponsor ID
- BIO-PROSA / RS1814/22
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Ospedale Sandro Pertini, Roma, Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Campus Bio-Medico University, Azienda Policlinico Umberto I, San Giovanni Addolorata Hospital, Ospedale "SS Annunziata", Chieti, Ospedale "Gaetano Bernabeo" , Ortona, Hospital San Pietro Fatebenefratelli, presidio Ospedaliero santo spirito in Sassia, Roma, Ospedale di Belcolle - Viterbo
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jun 2027 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan | – | Other: data collectionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic triple-negative breast cancer treated with socituzumab govitecan as indicated, with at least one sample of tumor tissue available.
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (3 listed)
- Patients with a history of other malignancies;
- Contraindications to the use of sacituzumab govitecan SG;
- Untreated and/or clinically unstable (symptomatic) brain metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionCollection 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 | Other | patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan |
Primary outcome
Biomolecular investigations conducted on multiple platforms
Time frame: 30 months
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.
3 secondary outcomes
PFS in patients.
Time frame: 30 months
Tolerability of the treatment
Time frame: 30 months
Development of organoids
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No. The Sponsor is the exclusive owner of all data and information arising from the study, including results, discoveries, know-how and the like.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eriseld Krasniqi, Doctor contact
Patrizia Vici, Doctor principal investigator
IRCCS "Regina Elena" National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Vici, Doctor (06-5266.5584 ext. +39, patrizia.vici@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomolecular investigations conducted on multiple platforms (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.