An observational study in Breast Cancer, sponsored by Istituti Clinici Scientifici Maugeri SpA. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Observational
Among 94 studies in Triple Negative Breast Neoplasms with a site in Italy — 28 open to participants now, 40 under way, 8 of them phase 3. Triple Negative Breast Neoplasms · Italy.
Among the 94 studies in Triple Negative Breast Neoplasms with a site in Italy, this one is one of 3 that started in 2026, is one of 9 observational ones, reaches primary completion later than 32 of the 39 other live ones, and was the 94th registered.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.
Browse Triple Negative Breast Neoplasms studies →28 of the 94 studies in Triple Negative Breast Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
University of Milan · Sites in Italy
Ages 18+ · Women only
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+ · Women only
Bristol-Myers Squibb · Sites in Italy, United States, Argentina and 25 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in Italy, United States, Argentina and 38 more countries
Ages 18+
Merck Sharp & Dohme LLC · Sites in Italy, United States, Argentina and 32 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 331 Triple Negative Breast Neoplasms studies recruiting now, 231 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
94 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 37 · Phase 2 36 · Phase 3 22
First in 2000; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 193 across 106 observational studies indexed under Triple Negative Breast Neoplasms.
Median enrollment 173 across the 85 interventional studies, 200 across the 9 observational. Of the 51 that completed or were terminated, 30 (59%) have results posted.
This tab as a report to print or save as PDF → With an account.
69 of 94 have an industry lead sponsor. The 10 most frequent:
Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 127 studies on the registry; 51 are open to participants now.
Istituti Clinici Scientifici Maugeri SpA has 3 studies filed under Triple Negative Breast Neoplasms — fewer than ten, so there is no comparison to draw.
11 of the studies in Triple Negative Breast Neoplasms with a site in Italy that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05382286Phase 3Gilead SciencesStudy of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer | 2027-02 |
| NCT05633654Phase 3Gilead SciencesStudy of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63) | 2027-06 |
| NCT04585750PMV Pharmaceuticals, IncThe Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | 2026-12-15 |
| NCT06690840European Institute of OncologyAtezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients | 2026-12-15 |
| NCT04561362BicycleTx LimitedStudy BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies | 2027-01 |
Add all 11 to your calendar (.ics) → With an account.
Among the 94 studies in Triple Negative Breast Neoplasms with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Triple-negative breast cancer (TNBC) is an aggressive subtype of cancer characterized by substantial heterogeneity in treatment response. Despite significant advances in therapeutic strategies, it remains difficult to accurately predict which patients will derive the greatest benefit from treatment. For this reason, identifying novel factors that may contribute to understanding and predicting treatment response became a conisiderable research priority.
In recent years, increasing evidence has highlighted the potential role of microorganisms present in the intestine (intestinal microbiota) and within tumor tissue (intratumoral microbiota) in modulating immune system activity and influencing the efficacy of anticancer treatments. At the same time, the composition and the functional state of immune cells within the tumor, known as the tumor immune microenvironment (TIME), represent important determinant in the host's ability to build a response against the disease.
In addition, small particles released by cells, known as extracellular vescicles (EVs), circulate in the blood and carry biological information reflecting the characteristics of their cells of origin. EVs analyisis may therefore provide a minimally invasive tool to monitor the disease and predict response to treatment through blood sampling.
This study aims to further investigate the role of intratumoral microbiota and tumor microenvironment in patients with TNBC. A better understanding of the interactions of these components with fecal microbiota and extracellular vescicles may contribute to the identification of new predictive biomarkers and, in the future, support the development of more personalized and effective therapeutic strategies.
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer characterized by the negligible expression of estrogen, progesterone, and HER2 receptors. Compared with other breast cancer subtypes, TNBC has historically had more limited therapeutic options and is associated with a heterogeneous clinical course and a variable response to treatment. Evidence shows that the introduction of combined chemotherapy and immunotherapy in the neoadjuvant treatment setting has improved the rate of pathological complete response (pCR) in patients with TNBC. However, not all patients benefit equally from treatment, and a substantial proportion of patients do not achieve pCR.
Identifying biological factors that contribute to this variability is therefore important to improve patient stratification and to recognize predictive biomarkers for treatment response.
Increasing evidence indicates that the microbiota may play an important role in regulating the response to anticancer treatment, by modulating the activity of the host immune system.
In several tumor types, such as melanoma, non-small cells lung carcinoma (NSCLC) and colorectal carcinoma (CRC), composition and functional activity of the intestinal microbiota have been associated with the efficacy of chemotherapy and immune checkpoint-based treatments. Specifically, the intestinal microbiota can influence systemic immune activity through interactions with immune cells, microbial metabolites and inflammatory pathways. Additionally, the tumor itself also contains a distinct microbial community. Tumor-associated microorganisms may interact directly with tumor cells and influence inflammatory signaling, antigen presentation, immune cell recruitment, and the functional state of immune cells. These processes can contribute to the composition and activity of the tumor immune microenvironment (TIME), which is an important determinant of tumor progression and response to systemic therapy. Hence, alterations in the composition of the microbiota may contribute to either an immune-permissive or an immunosuppressive tumor environment, influencing the ability of the tumor to respond to neoadjuvant therapy.
Consequently, the relationship between the intestinal microbiota, intratumoral microbiota and TIME emerges as a promising area of investigation in TNBC.
Preliminary studies conducted through collaboration between Istituti Clinici Maugeri and the Istituto Nazionale dei Tumori (INT) in patients with HER2-positive breast cancer have shown that the intestinal microbiota has an impact on the efficacy of trastuzumab and may distinguish patients who respond to treatment from those who do not achieve pCR.
In addition, studies conducted by the INT group have shown that specific bacteria can be detected within breast tumor tissue, independently of the breast cancer subtype. Specifically, the presence of Staphylococcus spp. within the tumor microenvironment (TME) was associated with immunosuppressive features, including increased infiltration of regulatory T-cells (Tregs) and a macrophage population shifted toward the immunosuppressive M2 state. These findings support the hypothesis that the intratumoral microbiota may contribute to shape the local immune environment and may, therefore, influence the response to treatment. The present study is based on the hypothesis that the composition of the intestinal and intratumoral microbiota might be associated with the characteristics of the TIME and with the response to neoadjuvant therapy in patients with TNBC. Accordingly, the study will investigate these components within the same prospective cohort, allowing the relationships between microbiota composition, TIME, and therapeutic response to be explored. This study will also include the investigation of circulating extracellular vescicles (EVs). EVs are membrane-enclose particles released by different cell types, including tumor cells and immune cells. EVs carry molecular cargo which includes proteins, nucleic acids, lipids, and other biologically active molecules, that potentially reflect the biological features and state of the cells from which they originate, including information related to the tumor and its surrounding microenvironment. Consequently, circulating EVs have gained significant attention as potential biomarkers in breast cancer. EVs analysis may therefore provide a minimally-invasive source of biological information that complements the analysis of tumor tissue. Previous work conducted by the ICS Maugeri group has characterized circulating EVs in patients with breast cancer and healthy individuals, developing ultrasensitive assays for the quantification of tumor-associated markers expressed on EVs subpopulations detected in plasma. In the present study, circulating EVs will be investigated as potential predictors of response to neoadjuvant therapy. The analysis of EV-associated markers may also provide additional information on tumor and immune-related processes that could be associated with treatment response.
The primary objective of the study is to characterize the composition of the tumor microbiota and the features of the TIME in patients with TNBC undergoing neoadjuvant therapy. Secondary objectives include the investigation of the relationship between the intestinal and intratumoral microbiota, the evaluation of their association with response to neoadjuvant therapy, and the investigation of circulating EVs as surrogate biomarkers of the TIME.
Overall, the study aims to provide a more comprehensive characterization of the biological factors associated with treatment response in TNBC, and, in the longer term, a better understanding of the interactions between the microbiota and the TIME could also help identify biological pathways that may represent potential therapeutic strategies.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.
This study's planned enrollment of 30 is below the median of 193 across 106 observational studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 127 studies on the registry; 51 are open to participants now.
Compared within Triple Negative Breast Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population will include patients referred to the Breast Unit of IRCCS ICS Maugeri of Pavia and the Istituto Nazionale dei Tumori of Milan, diagnosed with triple-negative breast cancer and scheduled for neoadjuvant treatment followed by surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
If a subject meets any of the following criteria, they must be excluded from the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intratumoral microbiota characterization
Measure of Staphylococcus spp. levels in tumor tissue
Time frame: From diagnostic biopsy (first time point) and at surgery (second time point).
Tumor immune microenvironment characterization
Measure of Treg and TAM in tumor tissue
Time frame: From diagnostic biopsy (first time point) and at surgery (second time point).
Extracellular vescicles analysis
Extracellular vescicles level on plasma samples
Time frame: From diagnostic biopsy (first time point) and at surgery (second time point).
Correlation between intratumor and fecal microbiota profiles
Correlation of bacterial species composition and microbial diversity between intratumor and fecal samples at different time points. Microbiota profiles will be assessed by bacterial species identification and alpha and beta diversity indexes.
Time frame: Prior to neoadjuvant chemotherapy and at surgery
Plan to share: No
Started Sep 2026 (actual). Primary completion is estimated for Aug 2029, 35 months after the start.
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Triple Negative Breast Neoplasms →
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