Breast CancerNCT07808086
Role of Tumor Microbiota in the Response to Neoadjuvant Therapy in Patients Affected by Triple Negative Breast Cancer
An observational study of Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 13 Aug 2029
- 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: 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.
Who may be able to join
- Female subjects
- Diagnosis of triple-negative breast cancer (TNBC)
- Aged 18 years or older
- Indication for neoadjuvant treatment with chemotherapy or chemo/immunotherapy.
- Patients willing and able to comply to standard oncological follow-up procedures.
- Subjects who agree to participate in the present study by signing and dating the informed consent form.
Who cannot join
- If a subject meets any of the following criteria, they must be excluded from the study.
- Patients that have already been treated with chemotherapy.
- Patients that did not receive an official cyto-histological diagnosis of breast cancer.
- Patients affected by other solid tumors other than breast cancer.
- Patients who have undergone antibiotic therapy within the 10 days prior to sample collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri Spa - Società Benefit IRCCS
Pavia, 27100
Dott.ssa Truffi Marta, +39 0382592219, marta.truffi@icsmaugeri.it
About this study
Official title: Study of the Role of the Tumor Microbiota in the Neoadjuvant Therapy Response on Triple Negative Breast Cancer Patients
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Keywords
- Intratumoral microbiota, Neoadjuvant therapy, Predictive biomarkers, Immunosuppression, Fecal microbiota, Tumor Immune Microenvironment, Extracellular vesicles, Triple negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Intratumoral microbiota characterization
Measure of Staphylococcus spp. levels in tumor tissue
Measured: From diagnostic biopsy (first time point) and at surgery (second time point).
Tumor immune microenvironment characterization
Measure of Treg and TAM in tumor tissue
Measured: From diagnostic biopsy (first time point) and at surgery (second time point).
Secondary outcomes (2)
Extracellular vescicles analysis
Extracellular vescicles level on plasma samples
Measured: 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.
Measured: Prior to neoadjuvant chemotherapy and at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Sep 2026
- Primary completion13 Aug 2029 (estimated)
- Study completion13 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Corsi, Istituti Clinici Scientifici Maugeri SpA
- Investigators
- Fabio Corsi, Prof., Principal investigator, ICS Maugeri SpA-SB - IRCCS Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808086
- Sponsor's protocol ID
- CTSPV104-26
- Status last verified
- Aug 2026
- First submitted
- 3 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
PubMed 15189396Morasso C, Ricciardi A, Sproviero D, Truffi M, Albasini S, Piccotti F, Sottotetti F, Mollica L, Cereda C, Sorrentino L, Corsi F. Fast quantification of extracellular vesicles levels in early breast cancer patients by Single Molecule Detection Array (SiMoA). Breast Cancer Res Treat. 2022 Feb;192(1):65-74. doi: 10.1007/s10549-021-06474-3. Epub 2021 Dec 21.
PubMed 34935096Bonizzi A, Signati L, Grimaldi M, Truffi M, Piccotti F, Gagliardi S, Dotti G, Mazzucchelli S, Albasini S, Cazzola R, Bhowmik D, Narayana C, Corsi F, Morasso C. Exploring breast cancer-related biochemical changes in circulating extracellular vesicles using Raman spectroscopy. Biosens Bioelectron. 2025 Jun 15;278:117287. doi: 10.1016/j.bios.2025.117287. Epub 2025 Feb 19.
PubMed 40023908Yeat NY, Chen RH. Extracellular vesicles: biogenesis mechanism and impacts on tumor immune microenvironment. J Biomed Sci. 2025 Sep 4;32(1):85. doi: 10.1186/s12929-025-01182-2.
PubMed 40908470Konig L, Kasimir-Bauer S, Bittner AK, Hoffmann O, Wagner B, Santos Manvailer LF, Kimmig R, Horn PA, Rebmann V. Elevated levels of extracellular vesicles are associated with therapy failure and disease progression in breast cancer patients undergoing neoadjuvant chemotherapy. Oncoimmunology. 2017 Sep 27;7(1):e1376153. doi: 10.1080/2162402X.2017.1376153. eCollection 2017.
PubMed 29296534Chen Q, Zhou Q. Identification of exosome-related gene signature as a promising diagnostic and therapeutic tool for breast cancer. Heliyon. 2024 Apr 16;10(8):e29551. doi: 10.1016/j.heliyon.2024.e29551. eCollection 2024 Apr 30.
PubMed 38665551Bernardo G, Le Noci V, Ottaviano E, De Cecco L, Camisaschi C, Guglielmetti S, Di Modica M, Gargari G, Bianchi F, Indino S, Sartori P, Borghi E, Sommariva M, Tagliabue E, Triulzi T, Sfondrini L. Reduction of Staphylococcus epidermidis in the mammary tumor microbiota induces antitumor immunity and decreases breast cancer aggressiveness. Cancer Lett. 2023 Feb 28;555:216041. doi: 10.1016/j.canlet.2022.216041. Epub 2022 Dec 22.
PubMed 36565918Di Modica M, Gargari G, Regondi V, Bonizzi A, Arioli S, Belmonte B, De Cecco L, Fasano E, Bianchi F, Bertolotti A, Tripodo C, Villani L, Corsi F, Guglielmetti S, Balsari A, Triulzi T, Tagliabue E. Gut Microbiota Condition the Therapeutic Efficacy of Trastuzumab in HER2-Positive Breast Cancer. Cancer Res. 2021 Apr 15;81(8):2195-2206. doi: 10.1158/0008-5472.CAN-20-1659. Epub 2021 Jan 22.
PubMed 33483370Zitvogel L, Derosa L, Routy B, Loibl S, Heinzerling L, de Vries IJM, Engstrand L; ONCOBIOME Network; Segata N, Kroemer G. Impact of the ONCOBIOME network in cancer microbiome research. Nat Med. 2025 Apr;31(4):1085-1098. doi: 10.1038/s41591-025-03608-8. Epub 2025 Apr 11.
PubMed 40217075Davar D, Zarour HM. Facts and Hopes for Gut Microbiota Interventions in Cancer Immunotherapy. Clin Cancer Res. 2022 Oct 14;28(20):4370-4384. doi: 10.1158/1078-0432.CCR-21-1129.
PubMed 35748749Liu C, Fu L, Wang Y, Yang W. Influence of the gut microbiota on immune cell interactions and cancer treatment. J Transl Med. 2024 Oct 15;22(1):939. doi: 10.1186/s12967-024-05709-3.
PubMed 39407240Xia L, Zhu X, Wang Y, Lu S. The gut microbiota improves the efficacy of immune-checkpoint inhibitor immunotherapy against tumors: From association to cause and effect. Cancer Lett. 2024 Aug 28;598:217123. doi: 10.1016/j.canlet.2024.217123. Epub 2024 Jul 20.
PubMed 39033797Jin M, Fang J, Peng J, Wang X, Xing P, Jia K, Hu J, Wang D, Ding Y, Wang X, Li W, Chen Z. PD-1/PD-L1 immune checkpoint blockade in breast cancer: research insights and sensitization strategies. Mol Cancer. 2024 Nov 29;23(1):266. doi: 10.1186/s12943-024-02176-8.
PubMed 39614285Chen Z, Liu Y, Lyu M, Chan CH, Sun M, Yang X, Qiao S, Chen Z, Yu S, Ren M, Lu A, Zhang G, Li F, Yu Y. Classifications of triple-negative breast cancer: insights and current therapeutic approaches. Cell Biosci. 2025 Feb 1;15(1):13. doi: 10.1186/s13578-025-01359-0.
PubMed 39893480
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of the Tumor Microbiota in the Neoadjuvant Therapy Response on Triple Negative Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07808086
- Acronym / sponsor ID
- CTSPV104-26
- Conditions
- Breast Cancer
- Keywords
- Intratumoral microbiota, Neoadjuvant therapy, Predictive biomarkers, Immunosuppression, Fecal microbiota, Tumor Immune Microenvironment, Extracellular vesicles, Triple negative breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 13 Aug 2029 (estimated)
- Study completion
- 13 Aug 2029 (estimated)
- First posted
- 8 Sep 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Female subjects
- Diagnosis of triple-negative breast cancer (TNBC)
- Aged 18 years or older
- Indication for neoadjuvant treatment with chemotherapy or chemo/immunotherapy.
- Patients willing and able to comply to standard oncological follow-up procedures.
Key exclusion criteria (5 listed)
- If a subject meets any of the following criteria, they must be excluded from the study.
- Patients that have already been treated with chemotherapy.
- Patients that did not receive an official cyto-histological diagnosis of breast cancer.
- Patients affected by other solid tumors other than breast cancer.
- Patients who have undergone antibiotic therapy within the 10 days prior to sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intratumoral microbiota characterization
Time frame: From diagnostic biopsy (first time point) and at surgery (second time point).
Measure of Staphylococcus spp. levels in tumor tissue
Tumor immune microenvironment characterization
Time frame: From diagnostic biopsy (first time point) and at surgery (second time point).
Measure of Treg and TAM in tumor tissue
2 secondary outcomes
Extracellular vescicles analysis
Time frame: From diagnostic biopsy (first time point) and at surgery (second time point).
Correlation between intratumor and fecal microbiota profiles
Time frame: Prior to neoadjuvant chemotherapy and at surgery
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 23 Sep 2026.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Background: PubMed 15189396Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
- Background: PubMed 34935096Morasso C, Ricciardi A, Sproviero D, Truffi M, Albasini S, Piccotti F, Sottotetti F, Mollica L, Cereda C, Sorrentino L, Corsi F. Fast quantification of extracellular vesicles levels in early breast cancer patients by Single Molecule Detection Array (SiMoA). Breast Cancer Res Treat. 2022 Feb;192(1):65-74. doi: 10.1007/s10549-021-06474-3. Epub 2021 Dec 21.
- Background: PubMed 40023908Bonizzi A, Signati L, Grimaldi M, Truffi M, Piccotti F, Gagliardi S, Dotti G, Mazzucchelli S, Albasini S, Cazzola R, Bhowmik D, Narayana C, Corsi F, Morasso C. Exploring breast cancer-related biochemical changes in circulating extracellular vesicles using Raman spectroscopy. Biosens Bioelectron. 2025 Jun 15;278:117287. doi: 10.1016/j.bios.2025.117287. Epub 2025 Feb 19.
- Background: PubMed 40908470Yeat NY, Chen RH. Extracellular vesicles: biogenesis mechanism and impacts on tumor immune microenvironment. J Biomed Sci. 2025 Sep 4;32(1):85. doi: 10.1186/s12929-025-01182-2.
- Background: PubMed 29296534Konig L, Kasimir-Bauer S, Bittner AK, Hoffmann O, Wagner B, Santos Manvailer LF, Kimmig R, Horn PA, Rebmann V. Elevated levels of extracellular vesicles are associated with therapy failure and disease progression in breast cancer patients undergoing neoadjuvant chemotherapy. Oncoimmunology. 2017 Sep 27;7(1):e1376153. doi: 10.1080/2162402X.2017.1376153. eCollection 2017.
- Background: PubMed 38665551Chen Q, Zhou Q. Identification of exosome-related gene signature as a promising diagnostic and therapeutic tool for breast cancer. Heliyon. 2024 Apr 16;10(8):e29551. doi: 10.1016/j.heliyon.2024.e29551. eCollection 2024 Apr 30.
- Background: PubMed 36565918Bernardo G, Le Noci V, Ottaviano E, De Cecco L, Camisaschi C, Guglielmetti S, Di Modica M, Gargari G, Bianchi F, Indino S, Sartori P, Borghi E, Sommariva M, Tagliabue E, Triulzi T, Sfondrini L. Reduction of Staphylococcus epidermidis in the mammary tumor microbiota induces antitumor immunity and decreases breast cancer aggressiveness. Cancer Lett. 2023 Feb 28;555:216041. doi: 10.1016/j.canlet.2022.216041. Epub 2022 Dec 22.
- Background: PubMed 33483370Di Modica M, Gargari G, Regondi V, Bonizzi A, Arioli S, Belmonte B, De Cecco L, Fasano E, Bianchi F, Bertolotti A, Tripodo C, Villani L, Corsi F, Guglielmetti S, Balsari A, Triulzi T, Tagliabue E. Gut Microbiota Condition the Therapeutic Efficacy of Trastuzumab in HER2-Positive Breast Cancer. Cancer Res. 2021 Apr 15;81(8):2195-2206. doi: 10.1158/0008-5472.CAN-20-1659. Epub 2021 Jan 22.
- Background: PubMed 40217075Zitvogel L, Derosa L, Routy B, Loibl S, Heinzerling L, de Vries IJM, Engstrand L; ONCOBIOME Network; Segata N, Kroemer G. Impact of the ONCOBIOME network in cancer microbiome research. Nat Med. 2025 Apr;31(4):1085-1098. doi: 10.1038/s41591-025-03608-8. Epub 2025 Apr 11.
- Background: PubMed 35748749Davar D, Zarour HM. Facts and Hopes for Gut Microbiota Interventions in Cancer Immunotherapy. Clin Cancer Res. 2022 Oct 14;28(20):4370-4384. doi: 10.1158/1078-0432.CCR-21-1129.
- Background: PubMed 39407240Liu C, Fu L, Wang Y, Yang W. Influence of the gut microbiota on immune cell interactions and cancer treatment. J Transl Med. 2024 Oct 15;22(1):939. doi: 10.1186/s12967-024-05709-3.
- Individual participant dataSharing planned: No
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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.
Fabio Corsi, Prof. principal investigator
ICS Maugeri SpA-SB - IRCCS Pavia
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 Istituti Clinici Scientifici Maugeri SpA 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 6 inclusion and 5 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 23 Sep 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 Prof. Fabio Corsi (+39 0382592272, fabio.corsi@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intratumoral microbiota characterization (time frame: From diagnostic biopsy (first time point) and at surgery (second time point).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808086, which also lists 16 linked publications.
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 23 Sep 2026.