Breast Cancer FemaleNCT04767659
Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging
A study testing MAMMOT2 in people with Breast Cancer Female and Chemotherapy Effect, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Neoadjuvant chemotherapy (NAC) is the first line treatment for locally advanced breast cancer (BC). Besides making breast conserving surgery feasible, its main aim is to achieve a pathological complete response (pCR). Previous studies demonstrated that a pCR correlated with a higher disease-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Chemotherapy Effect
- What is being tested?
- MAMMOT2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2020to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Women above 18 years of age
- Women with a recent diagnosis of breast cancer candidate for neoadjuvant chemotherapy
- Women willing to give informed consent
Who cannot join
- Subject is pregnant or breastfeeding
- Subject is unable or unwilling to give informed consent
- Previous surgery of the same breast
- Presence of distant metastasis
- Breast implants
Trial locations and contacts
1 site in 1 country.
CAROLINA SANTANGELO contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan, 20132
PIETRO PANIZZA, panizza.pietro@hsr.it
About this study
Official title: Optical Monitoring of Neoadjuvant Chemotherapy and Prediction of Pathological Complete Response in Breast Cancer Patients
Neoadjuvant chemotherapy (NAC) is the first line treatment for locally advanced breast cancer (BC). Besides making breast conserving surgery feasible, its main aim is to achieve a pathological complete response (pCR). Previous studies demonstrated that a pCR correlated with a higher disease-free survival. Tumor response may vary among different BC subtypes and only 30% of BC respond completely to NAC. Treating chemo-resistant disease with NAC may cause patient harm due to drug toxicity and surgery delay.
It is therefore very important to promptly identify those women who will not benefit from NAC.
Read more
Mammography and ultrasound proved ineffective in monitoring changes in lesion size due to therapy-induced fibrosis. MRI is the most accurate imaging technique for assessing early clinical response by measuring tumor size, however its accuracy is lower post NAC. This necessitates the need for a new technique able to non invasively assess the effectiveness of NAC. Optical techniques are sensitive to the biological changes that occur within the tumor after NAC administration. These changes occur prior to tumor size reduction.
Optically estimated total hemoglobin concentration correlates with the histological analysis of vasculature as well as with tumor-associated angiogenesis which can affect tumor changes during NAC. Other promising biomarkers related to tissue composition (water, lipid, collagen content) and structure (scattering) may also be evaluated by optical techniques.
The aim of the study is to monitor the effectiveness of NAC in BC patients with a near infrared spectroscopic imaging platform which allows to non-invasively detect changes in vascularization and size of BC and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers (oxy- and deoxyhemoglobin, water, lipid and collagen concentration, scattering) within tissue during NAC.
This optical imaging technique will provide a non-invasive, safe and relatively inexpensive tool to monitor patients' response to NAC and to predict their outcome.
Read the detailed description
In this study, an accurate, reliable, non-invasive modality with good patient tolerance will be tested to predict response to NAC in order to tailor the medical and surgical treatment.
The aim of this project is to monitor the effectiveness of NAC in BC patients with a new near infrared spectroscopic imaging platform which allows to non-invasively detect changes in size, vascularization and blood oxygenation in tumors and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers like oxy- and deoxyhemoglobin, water, lipid and collagen and scattering in the tissue during NAC. This optical imaging tool will allow a non-invasive, safe and relatively inexpensive monitoring of NAC and prediction of patients' outcome.
A single-site, national, non-comparative, non-randomized study will be conducted at the San Raffaele Hospital in Milan in collaboration with the Politecnico di Milano. The medical device is a prototype developed by Politecnico di Milano.
Twenty adult women with a recent diagnosis of breast cancer and candidate for NAC, who fulfil the inclusion criteria and agree to voluntary participate in the study under informed consent, will be enrolled.
Besides assessing the response to neoadjuvant chemotherapy using conventional imaging evaluation (x-ray mammography and breast ultrasound prior to commencement/baseline, half way through and on completion of NAC; contrast-enhanced MRI prior to commencement/baseline and on completion of NAC), the patients enrolled will be evaluated with optical imaging at the following six selected time points (prior to commencement of NAC/baseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC).
A preliminary phase will be performed on the first 5 patients out of the 20 patients enrolled, in order to evaluate the potential artefacts related to a recent breast biopsy and to the positioning of a clip. In this preliminary phase, 2 additional optical evaluations will be carried out, one prior to the breast biopsy and one after the positioning of the clip.
Patients are enrolled in the study for the entire duration of NAC. No follow-up is required and patients will be followed according to the regular clinical standard of care. Moreover, the outcome of the optical investigation does not affect the treatment and management of the women enrolled in the study.
The duration of enrolment of the study is expected to be approximately 12 months. The study will end when the last patient enrolled will complete her chemotherapy treatment.
- Conditions
- Breast Cancer Female, Chemotherapy Effect
- Being tested
- MAMMOT2
- Keywords
- Neoadjuvant chemotherapy, Pathological complete response, Optical imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAMMOT2Device
Breast cancer patients candidate for neoadjuvant chemotherapy will be evaluated with optical imaging prior to commencement of NAC/baseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC. 2 additional optical evaluations will be carried out on the first 5 patients enrolled, one before breast biopsy and one after the positioning of the metallic clip, in order to evaluate the potential artefacts related to these procedures.
| Study group | Role | What they receive |
|---|---|---|
| Women candidate for clinical trial | Experimental | Twenty adult women with a recent diagnosis of breast cancer, candidate for NAC, besides assessing the response to neoadjuvant chemotherapy using standard imaging evaluation, will undergo optical imaging at six selected time points from prior to commencement of NAC/baseline to the completion of NAC treatment (prior to surgery). Receives: Device: MAMMOT2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical monitoring of neoadjuvant chemotherapy in breast cancer patients
Optical data will be compared to the conventional imaging results and to the surgical specimen histology (gold standard)
Measured: The through completion study is that of an average of 1 year
Prediction of pathological complete response to neoadjuvant chemotherapy using optical imaging
Optical data will be evaluated to distinguish responders from non responders
Measured: The through completion study is that of an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start27 Jan 2020
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano
- Responsible party
- Principal investigator, Pietro Panizza, IRCCS San Raffaele
- Investigators
- PANIZZA, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767659
- Sponsor's protocol ID
- NADOPTIC
- Status last verified
- Sep 2024
- First submitted
- 12 Jan 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wabnitz H, Taubert DR, Mazurenka M, Steinkellner O, Jelzow A, Macdonald R, Milej D, Sawosz P, Kacprzak M, Liebert A, Cooper R, Hebden J, Pifferi A, Farina A, Bargigia I, Contini D, Caffini M, Zucchelli L, Spinelli L, Cubeddu R, Torricelli A. Performance assessment of time-domain optical brain imagers, part 1: basic instrumental performance protocol. J Biomed Opt. 2014 Aug;19(8):086010. doi: 10.1117/1.JBO.19.8.086010.
PubMed 25121479Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet. 2012 Nov 17;380(9855):1778-86. doi: 10.1016/S0140-6736(12)61611-0. Epub 2012 Oct 30.
PubMed 23117178Brem RF, Lenihan MJ, Lieberman J, Torrente J. Screening breast ultrasound: past, present, and future. AJR Am J Roentgenol. 2015 Feb;204(2):234-40. doi: 10.2214/AJR.13.12072.
PubMed 25615743Liu B, Zheng Y, Huang G, Lin M, Shan Q, Lu Y, Tian W, Xie X. Breast Lesions: Quantitative Diagnosis Using Ultrasound Shear Wave Elastography-A Systematic Review and Meta--Analysis. Ultrasound Med Biol. 2016 Apr;42(4):835-47. doi: 10.1016/j.ultrasmedbio.2015.10.024. Epub 2016 Jan 6.
PubMed 26778289Durduran T, Choe R, Baker WB, Yodh AG. Diffuse Optics for Tissue Monitoring and Tomography. Rep Prog Phys. 2010 Jul;73(7):076701. doi: 10.1088/0034-4885/73/7/076701.
PubMed 26120204Leff DR, Warren OJ, Enfield LC, Gibson A, Athanasiou T, Patten DK, Hebden J, Yang GZ, Darzi A. Diffuse optical imaging of the healthy and diseased breast: a systematic review. Breast Cancer Res Treat. 2008 Mar;108(1):9-22. doi: 10.1007/s10549-007-9582-z. Epub 2007 Apr 28.
PubMed 17468951Taroni P, Pifferi A, Salvagnini E, Spinelli L, Torricelli A, Cubeddu R. Seven-wavelength time-resolved optical mammography extending beyond 1000 nm for breast collagen quantification. Opt Express. 2009 Aug 31;17(18):15932-46. doi: 10.1364/OE.17.015932.
PubMed 19724592Ferocino E, Martinenghi E, Dalla Mora A, Pifferi A, Cubeddu R, Taroni P. High throughput detection chain for time domain optical mammography. Biomed Opt Express. 2018 Jan 23;9(2):755-770. doi: 10.1364/BOE.9.000755. eCollection 2018 Feb 1.
PubMed 29552410Quarto G, Spinelli L, Pifferi A, Torricelli A, Cubeddu R, Abbate F, Balestreri N, Menna S, Cassano E, Taroni P. Estimate of tissue composition in malignant and benign breast lesions by time-domain optical mammography. Biomed Opt Express. 2014 Sep 18;5(10):3684-98. doi: 10.1364/BOE.5.003684. eCollection 2014 Oct 1.
PubMed 25360382Taroni P, Quarto G, Pifferi A, Ieva F, Paganoni AM, Abbate F, Balestreri N, Menna S, Cassano E, Cubeddu R. Optical identification of subjects at high risk for developing breast cancer. J Biomed Opt. 2013 Jun;18(6):060507. doi: 10.1117/1.JBO.18.6.060507.
PubMed 23804215Taroni P, Paganoni AM, Ieva F, Pifferi A, Quarto G, Abbate F, Cassano E, Cubeddu R. Non-invasive optical estimate of tissue composition to differentiate malignant from benign breast lesions: A pilot study. Sci Rep. 2017 Jan 16;7:40683. doi: 10.1038/srep40683.
PubMed 28091596Pearlman PC, Adams A, Elias SG, Mali WP, Viergever MA, Pluim JP. Mono- and multimodal registration of optical breast images. J Biomed Opt. 2012 Aug;17(8):080901-1. doi: 10.1117/1.JBO.17.8.080901.
PubMed 23224161Tavakoli B, Zhu Q. Two-step reconstruction method using global optimization and conjugate gradient for ultrasound-guided diffuse optical tomography. J Biomed Opt. 2013 Jan;18(1):16006. doi: 10.1117/1.JBO.18.1.016006.
PubMed 23296038
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Monitoring of Neoadjuvant Chemotherapy and Prediction of Pathological Complete Response in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04767659
- Acronym / sponsor ID
- NADOPTIC
- Conditions
- Breast Cancer Female, Chemotherapy Effect
- Keywords
- Neoadjuvant chemotherapy, Pathological complete response, Optical imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Politecnico di Milano
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 23 Feb 2021 (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.
Neoadjuvant chemotherapy (NAC) is the first line treatment for locally advanced breast cancer (BC). Besides making breast conserving surgery feasible, its main aim is to achieve a pathological complete response (pCR). Previous studies demonstrated that a pCR correlated with a higher disease-free survival. Tumor response may vary among different BC subtypes and only 30% of BC respond completely to NAC. Treating chemo-resistant disease with NAC may cause patient harm due to drug toxicity and surgery delay.
It is therefore very important to promptly identify those women who will not benefit from NAC.
Mammography and ultrasound proved ineffective in monitoring changes in lesion size due to therapy-induced fibrosis. MRI is the most accurate imaging technique for assessing early clinical response by measuring tumor size, however its accuracy is lower post NAC. This necessitates the need for a new technique able to non invasively assess the effectiveness of NAC. Optical techniques are sensitive to the biological changes that occur within the tumor after NAC administration. These changes occur prior to tumor size reduction.
Optically estimated total hemoglobin concentration correlates with the histological analysis of vasculature as well as with tumor-associated angiogenesis which can affect tumor changes during NAC. Other promising biomarkers related to tissue composition (water, lipid, collagen content) and structure (scattering) may also be evaluated by optical techniques.
The aim of the study is to monitor the effectiveness of NAC in BC patients with a near infrared spectroscopic imaging platform which allows to non-invasively detect changes in vascularization and size of BC and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers (oxy- and deoxyhemoglobin, water, lipid and collagen concentration, scattering) within tissue during NAC.
This optical imaging technique will provide a non-invasive, safe and relatively inexpensive tool to monitor patients' response to NAC and to predict their outcome.
Detailed description
In this study, an accurate, reliable, non-invasive modality with good patient tolerance will be tested to predict response to NAC in order to tailor the medical and surgical treatment.
The aim of this project is to monitor the effectiveness of NAC in BC patients with a new near infrared spectroscopic imaging platform which allows to non-invasively detect changes in size, vascularization and blood oxygenation in tumors and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers like oxy- and deoxyhemoglobin, water, lipid and collagen and scattering in the tissue during NAC. This optical imaging tool will allow a non-invasive, safe and relatively inexpensive monitoring of NAC and prediction of patients' outcome.
A single-site, national, non-comparative, non-randomized study will be conducted at the San Raffaele Hospital in Milan in collaboration with the Politecnico di Milano. The medical device is a prototype developed by Politecnico di Milano.
Twenty adult women with a recent diagnosis of breast cancer and candidate for NAC, who fulfil the inclusion criteria and agree to voluntary participate in the study under informed consent, will be enrolled.
Besides assessing the response to neoadjuvant chemotherapy using conventional imaging evaluation (x-ray mammography and breast ultrasound prior to commencement/baseline, half way through and on completion of NAC; contrast-enhanced MRI prior to commencement/baseline and on completion of NAC), the patients enrolled will be evaluated with optical imaging at the following six selected time points (prior to commencement of NAC/baseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC).
A preliminary phase will be performed on the first 5 patients out of the 20 patients enrolled, in order to evaluate the potential artefacts related to a recent breast biopsy and to the positioning of a clip. In this preliminary phase, 2 additional optical evaluations will be carried out, one prior to the breast biopsy and one after the positioning of the clip.
Patients are enrolled in the study for the entire duration of NAC. No follow-up is required and patients will be followed according to the regular clinical standard of care. Moreover, the outcome of the optical investigation does not affect the treatment and management of the women enrolled in the study.
The duration of enrolment of the study is expected to be approximately 12 months. The study will end when the last patient enrolled will complete her chemotherapy treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women candidate for clinical trial | Experimental | Device: MAMMOT2Twenty adult women with a recent diagnosis of breast cancer, candidate for NAC, besides assessing the response to neoadjuvant chemotherapy using standard imaging evaluation, will undergo optical imaging at six selected time points from prior to commencement of NAC/baseline to the completion of NAC treatment (prior to surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women above 18 years of age
- Women with a recent diagnosis of breast cancer candidate for neoadjuvant chemotherapy
- Women willing to give informed consent
Key exclusion criteria (5 listed)
- Subject is pregnant or breastfeeding
- Subject is unable or unwilling to give informed consent
- Previous surgery of the same breast
- Presence of distant metastasis
- Breast implants
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 |
|---|---|---|
| MAMMOT2Breast cancer patients candidate for neoadjuvant chemotherapy will be evaluated with optical imaging prior to commencement of NAC/baseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC. 2 additional optical evaluations will be carried out on the first 5 patients enrolled, one before breast biopsy and one after the positioning of the metallic clip, in order to evaluate the potential artefacts related to these procedures. | Device | Women candidate for clinical trial |
Primary outcome
Optical monitoring of neoadjuvant chemotherapy in breast cancer patients
Time frame: The through completion study is that of an average of 1 year
Optical data will be compared to the conventional imaging results and to the surgical specimen histology (gold standard)
Prediction of pathological complete response to neoadjuvant chemotherapy using optical imaging
Time frame: The through completion study is that of an average of 1 year
Optical data will be evaluated to distinguish responders from non responders
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 25121479Wabnitz H, Taubert DR, Mazurenka M, Steinkellner O, Jelzow A, Macdonald R, Milej D, Sawosz P, Kacprzak M, Liebert A, Cooper R, Hebden J, Pifferi A, Farina A, Bargigia I, Contini D, Caffini M, Zucchelli L, Spinelli L, Cubeddu R, Torricelli A. Performance assessment of time-domain optical brain imagers, part 1: basic instrumental performance protocol. J Biomed Opt. 2014 Aug;19(8):086010. doi: 10.1117/1.JBO.19.8.086010.
- Background: PubMed 23117178Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast cancer screening: an independent review. Lancet. 2012 Nov 17;380(9855):1778-86. doi: 10.1016/S0140-6736(12)61611-0. Epub 2012 Oct 30.
- Background: PubMed 25615743Brem RF, Lenihan MJ, Lieberman J, Torrente J. Screening breast ultrasound: past, present, and future. AJR Am J Roentgenol. 2015 Feb;204(2):234-40. doi: 10.2214/AJR.13.12072.
- Background: PubMed 26778289Liu B, Zheng Y, Huang G, Lin M, Shan Q, Lu Y, Tian W, Xie X. Breast Lesions: Quantitative Diagnosis Using Ultrasound Shear Wave Elastography-A Systematic Review and Meta--Analysis. Ultrasound Med Biol. 2016 Apr;42(4):835-47. doi: 10.1016/j.ultrasmedbio.2015.10.024. Epub 2016 Jan 6.
- Background: PubMed 26120204Durduran T, Choe R, Baker WB, Yodh AG. Diffuse Optics for Tissue Monitoring and Tomography. Rep Prog Phys. 2010 Jul;73(7):076701. doi: 10.1088/0034-4885/73/7/076701.
- Background: PubMed 17468951Leff DR, Warren OJ, Enfield LC, Gibson A, Athanasiou T, Patten DK, Hebden J, Yang GZ, Darzi A. Diffuse optical imaging of the healthy and diseased breast: a systematic review. Breast Cancer Res Treat. 2008 Mar;108(1):9-22. doi: 10.1007/s10549-007-9582-z. Epub 2007 Apr 28.
- Background: PubMed 19724592Taroni P, Pifferi A, Salvagnini E, Spinelli L, Torricelli A, Cubeddu R. Seven-wavelength time-resolved optical mammography extending beyond 1000 nm for breast collagen quantification. Opt Express. 2009 Aug 31;17(18):15932-46. doi: 10.1364/OE.17.015932.
- Background: PubMed 29552410Ferocino E, Martinenghi E, Dalla Mora A, Pifferi A, Cubeddu R, Taroni P. High throughput detection chain for time domain optical mammography. Biomed Opt Express. 2018 Jan 23;9(2):755-770. doi: 10.1364/BOE.9.000755. eCollection 2018 Feb 1.
- Background: PubMed 25360382Quarto G, Spinelli L, Pifferi A, Torricelli A, Cubeddu R, Abbate F, Balestreri N, Menna S, Cassano E, Taroni P. Estimate of tissue composition in malignant and benign breast lesions by time-domain optical mammography. Biomed Opt Express. 2014 Sep 18;5(10):3684-98. doi: 10.1364/BOE.5.003684. eCollection 2014 Oct 1.
- Background: PubMed 23804215Taroni P, Quarto G, Pifferi A, Ieva F, Paganoni AM, Abbate F, Balestreri N, Menna S, Cassano E, Cubeddu R. Optical identification of subjects at high risk for developing breast cancer. J Biomed Opt. 2013 Jun;18(6):060507. doi: 10.1117/1.JBO.18.6.060507.
- Background: PubMed 28091596Taroni P, Paganoni AM, Ieva F, Pifferi A, Quarto G, Abbate F, Cassano E, Cubeddu R. Non-invasive optical estimate of tissue composition to differentiate malignant from benign breast lesions: A pilot study. Sci Rep. 2017 Jan 16;7:40683. doi: 10.1038/srep40683.
- Background: PubMed 23224161Pearlman PC, Adams A, Elias SG, Mali WP, Viergever MA, Pluim JP. Mono- and multimodal registration of optical breast images. J Biomed Opt. 2012 Aug;17(8):080901-1. doi: 10.1117/1.JBO.17.8.080901.
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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. This study is not recruiting at the moment.
CAROLINA SANTANGELO contact
PANIZZA principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAMMOT2 in people with Breast Cancer Female and Chemotherapy Effect, run by IRCCS San Raffaele 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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PIETRO PANIZZA, PI (02-26436310, panizza.pietro@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical monitoring of neoadjuvant chemotherapy in breast cancer patients (time frame: The through completion study is that of an average of 1 year). 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 NCT04767659, which also lists 13 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 19 Sep 2024.