Early Breast CancerNEOMETNCT06928701
Impact of "Targeted" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)
A study testing omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid) in people with Early Breast Cancer and Neoadjuvant Treatment, run by University of Eastern Piedmont at 1 site in Italy.
Trial summary
NEOMET is an exploratory randomized prospective, multicenter study whose primary aim is to explore if metabolomic signatures can be modified by a lifestyle intervention including dietary supplements and physical exercise intervention, in eBC patients candidate to NAT. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Breast Cancer, Neoadjuvant Treatment
- What is being tested?
- omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2024to Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- - Women (regardless of menopausal status) ≥ 18 years of age
- Pathologic confirmation of breast cancer by tumor biopsy
- Immunohistochemical assessment (as per local standards) of ER and PgR status, HER2 status;
- Stage I-III breast cancer without evidence of distant metastases
- Being candidate to standard neoadjuvant therapy
- Having available tumor tissue from breast and/or lymph node at baseline
Show all 9Show fewer
- Ability to fill a nutritional daily diary
- Medical clearance for non-agonistic physical activity
- Written informed consent to study-specific procedures
Who cannot join
- - locally advanced or inflammatory or stage IV BC;
- tumor size < 1 cm with negative nodes (pT1a, N0);
- chronic diseases or orthopedic issues that might interfere with ability to undertake a dietary and physical activity program;
- personal history of eating disorders.
- women engaged in agonistic/vigorous sport activities, not able to be compliant to exercise schedules
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
AOU Maggiore della Carità
Novara, Novara, 28100
Alessandra Gennari, alessandra.gennari@uniupo.it
About this study
Official title: A Phase II Randomized Trial to Evaluate the Impact of "Targeted" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)
NEOMET is an exploratory randomized prospective, multicenter study whose primary aim is to explore if metabolomic signatures can be modified by a lifestyle intervention including dietary supplements and physical exercise intervention, in eBC patients candidate to NAT. Eligible patients will be randomised to one of 4 groups: A. NAT, according to molecular subtype; B. NAT plus nutritional supplementation; C. NAT plus supervised physical exercise; D. NAT plus supervised physical exercise plus nutritional supplementation. Nutritional supplementazion will consist of two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid).
Read the detailed description
The primary objectives are: 1. To explore the impact of a lifestyle intervention including dietary supplements and physical exercise on the modulation of metabolomic signatures in eBC patients candidate to NAT; 2. To assess the Omega-3 Index at baseline and before surgery in all patient cohorts. Secondary objectives are: Impact of the combined lifestyle intervention on patient metabolic profile and body composition, by bioelectrical Impedance analysis; assessment of the immunophenotype of lymphocyte subpopulations and their correlation with metabolomic profile and response to therapy; characterization of immune-related and metabolic-related gene-expression signatures in tumor tissue and their correlation with metabolomic profile and response to therapy; evaluation of the pharmacokinetic interactions between nutritional supplementation and chemotherapy; evaluation of pCR in the different treatment arms; changes in health-related QoL (EORTC QLQ-C30, QLQ-BR45, and EQ-5D-5L), and safety and toxicity profiles according to the NCI-CTCAE v.5.0.
Due to explorative intent of the study no formal sample size calculation is provided. A total of 160 consecutive patients will be enrolled into the four arms of the study, with an allocation ratio equal to 1:1:1:1 (40 pts/arm). It can be estimated that the accrual will be completed in 20 months. Data collection, molecular assessments and data analysis with final scientific output are expected to extend the study duration to a total of 26 months.
The following analyses will be performed: - Conversion rate from a poor to a good metabolomic prognostic signature from baseline to end of NAT. - Change in Omega-3 Index and body composition variation.
- The association between Immunophenotype of lymphocyte subpopulations and tissue-based metabolic and immune-related gene-expression signatures will be described according to the type of metabolomic profile at baseline (poor versus good) and with response to therapy (pCR versus RD).
- Conditions
- Early Breast Cancer, Neoadjuvant Treatment
- Being tested
- omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)
- Keywords
- treatment response, metabolomics, nutritional intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)Dietary supplement
Nutritional supplements
| Study group | Role | What they receive |
|---|---|---|
| A - treatment of physician choice | No intervention | Conventional anti-cancer treatment, according to the molecular subtype and standard of care; all patients in Arm A will also receive general recommendations on lifestyle, including weight control and physical activity as indicated by WHO and EUSOMA criteria (control arm). |
| B - nutritional supplementation | Experimental | Conventional anti-cancer treatment, according to the molecular subtype plus nutritional supplementation.
Patients will be required to take on a daily basis two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), respectively at a dose of 700mg and 240mg, through 1 softgel twice a day. Besides, patients will be provided with a source of palmitoleic acid (hexadecenoic acid) equivalent to 1000mg of pure palmitoleic acid on a daily basis, through one daily 7 ml vial. Receives: Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid) |
| C - physical activity | Experimental | Conventional anti-cancer treatment, according to the molecular subtype plus indication for supervised physical exercise Receives: Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid) |
| D - nutritional supplementation plus physical activity | Experimental | Conventional anti-cancer treatment, according to the molecular subtype plus indication for supervised exercise training plus nutritional supplementation Receives: Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of fatty acids concentration
Plasma metabolic sample will be analyzed using a GCxGC-MS instrument for the relative and absolute quantification of small molecules in order to evaluate the impact of a lifestyle intervention including dietary supplements and physical exercise on the modulation of metabolomic signatures in eBC patients candidate to NACT.
Measured: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Omega3 Index
Assessment of Omega-3 Index in all patients cohorts at:
- baseline
- pre-operatative (at the end of NACT)
The omega3 index will assessed by the sum of DHA and EPA in erythrocytes expressed as a percentage of total erythrocyte fatty acid.
Measured: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Secondary outcomes (7)
Combined lifestyle intervention
Impact of the combined lifestyle intervention on body composition. Body composition will be assessed with a multifrequency bioelectrical impedance analysis.
Measured: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Lymphocyte subpopulations
Assessment of the immunophenotype of lymphocyte subpopulations and their correlation with metabolomic profile and response to therapy; characterization of immune-related and metabolic-related gene-expression signatures in tumor tissue and their correlation with metabolomic profile and response to therapy.
Lymphocyte subpopulation will be assessed collecting blood at 1st cycle and at the last cycle of NACT (before surgery). Gene-expression signatures will be assessed on tumor biopsy and surgery tissue.
Measured: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Antitumor activity
evaluation of pathological Complete Response (pCR) in the different treatment arms (ypT0/Tis ypN0)
Measured: From T0 until surgery, approximately 6 months (according to biological subtype)
changes in health-related Quality of Life
Quality of Life will be assessed among all patients included in the study using patient-reported outcomes (PROs) collected using a validated and standardized questionnaire: the European Organization for Cancer Research and Treatment Quality of Life Questionnaire C30, ranging from 0 to 100. A high-scale score represents a higher response level.
Measured: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: at three months after inclusion; T2: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
changes in health-related Quality of Life
Quality of Life will be assessed among all patients included in the study using patient-reported outcomes (PROs) collected using a validated and standardized questionnaire: the European Organization for Cancer Research and Treatment Quality of Life Questionnaire BR45, ranging from 0 to 100. A high-scale score represents a higher response level.
Measured: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: at three months after inclusion; T2: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
changes in health-related Quality of Life
Quality of Life will be assessed among all patients included in the study using patient-reported outcomes (PROs) collected using a validated and standardized questionnaire: Hospital Anxiety and Depression Scale, ranging from 0 to 21. A high-scale score represents a lower response level (0-7 normal, 8-10 borderline, 11-21 abnormal).
Measured: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: at three months after inclusion; T2: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Impact on treatment-related adverse events
Evaluation of safety and toxicity profiles according to the NCI-CTCAE (Common Terminology Criteria for Adverse Events) v.5.0.
Measured: Evaluation will be performed before of each cycle of NACT (each cycle is 21 days). NACT is approximately 6 months, according to biological subtype.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomised to one of 4 groups: A. NAT, according to molecular subtype; B. NAT plus nutritional supplementation; C. NAT plus supervised physical exercise; D. NAT plus supervised physical exercise plus nutritional supplementation. Nutritional supplementazion will consist of two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid).
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Piedmont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Gennari, University of Eastern Piedmont
- Investigators
- Alessandra Gennari, MD, Study chair, University of Piemonte Orientale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928701
- Sponsor's protocol ID
- 02UPODIMETONCO
- Acronym
- NEOMET
- Status last verified
- Apr 2025
- First submitted
- 3 Jul 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial to Evaluate the Impact of "Targeted" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)
- ClinicalTrials.gov ID
- NCT06928701
- Acronym / sponsor ID
- NEOMET / 02UPODIMETONCO
- Conditions
- Early Breast Cancer, Neoadjuvant Treatment
- Keywords
- treatment response, metabolomics, nutritional intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Eastern PiedmontUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Apr 2025 (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.
NEOMET is an exploratory randomized prospective, multicenter study whose primary aim is to explore if metabolomic signatures can be modified by a lifestyle intervention including dietary supplements and physical exercise intervention, in eBC patients candidate to NAT. Eligible patients will be randomised to one of 4 groups: A. NAT, according to molecular subtype; B. NAT plus nutritional supplementation; C. NAT plus supervised physical exercise; D. NAT plus supervised physical exercise plus nutritional supplementation. Nutritional supplementazion will consist of two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid).
Detailed description
The primary objectives are: 1. To explore the impact of a lifestyle intervention including dietary supplements and physical exercise on the modulation of metabolomic signatures in eBC patients candidate to NAT; 2. To assess the Omega-3 Index at baseline and before surgery in all patient cohorts. Secondary objectives are: Impact of the combined lifestyle intervention on patient metabolic profile and body composition, by bioelectrical Impedance analysis; assessment of the immunophenotype of lymphocyte subpopulations and their correlation with metabolomic profile and response to therapy; characterization of immune-related and metabolic-related gene-expression signatures in tumor tissue and their correlation with metabolomic profile and response to therapy; evaluation of the pharmacokinetic interactions between nutritional supplementation and chemotherapy; evaluation of pCR in the different treatment arms; changes in health-related QoL (EORTC QLQ-C30, QLQ-BR45, and EQ-5D-5L), and safety and toxicity profiles according to the NCI-CTCAE v.5.0.
Due to explorative intent of the study no formal sample size calculation is provided. A total of 160 consecutive patients will be enrolled into the four arms of the study, with an allocation ratio equal to 1:1:1:1 (40 pts/arm). It can be estimated that the accrual will be completed in 20 months. Data collection, molecular assessments and data analysis with final scientific output are expected to extend the study duration to a total of 26 months.
The following analyses will be performed: - Conversion rate from a poor to a good metabolomic prognostic signature from baseline to end of NAT. - Change in Omega-3 Index and body composition variation.
- The association between Immunophenotype of lymphocyte subpopulations and tissue-based metabolic and immune-related gene-expression signatures will be described according to the type of metabolomic profile at baseline (poor versus good) and with response to therapy (pCR versus RD).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Eligible patients will be randomised to one of 4 groups: A. NAT, according to molecular subtype; B. NAT plus nutritional supplementation; C. NAT plus supervised physical exercise; D. NAT plus supervised physical exercise plus nutritional supplementation. Nutritional supplementazion will consist of two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid).
| Arm | Type | Receives |
|---|---|---|
| A - treatment of physician choice | No intervention | –Conventional anti-cancer treatment, according to the molecular subtype and standard of care; all patients in Arm A will also receive general recommendations on lifestyle, including weight control and physical activity as indicated by WHO and EUSOMA criteria (control arm). |
| B - nutritional supplementation | Experimental | Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)Conventional anti-cancer treatment, according to the molecular subtype plus nutritional supplementation. Patients will be required to take on a daily basis two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), respectively at a dose of 700mg and 240mg, through 1 softgel twice a day. Besides, patients will be provided with a source of palmitoleic acid (hexadecenoic acid) equivalent to 1000mg of pure palmitoleic acid on a daily basis, through one daily 7 ml vial. |
| C - physical activity | Experimental | Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)Conventional anti-cancer treatment, according to the molecular subtype plus indication for supervised physical exercise |
| D - nutritional supplementation plus physical activity | Experimental | Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)Conventional anti-cancer treatment, according to the molecular subtype plus indication for supervised exercise training plus nutritional supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - Women (regardless of menopausal status) ≥ 18 years of age
- Pathologic confirmation of breast cancer by tumor biopsy
- Immunohistochemical assessment (as per local standards) of ER and PgR status, HER2 status;
- Stage I-III breast cancer without evidence of distant metastases
- Being candidate to standard neoadjuvant therapy
Key exclusion criteria (5 listed)
- - locally advanced or inflammatory or stage IV BC;
- tumor size < 1 cm with negative nodes (pT1a, N0);
- chronic diseases or orthopedic issues that might interfere with ability to undertake a dietary and physical activity program;
- personal history of eating disorders.
- women engaged in agonistic/vigorous sport activities, not able to be compliant to exercise schedules
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 |
|---|---|---|
| omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)Nutritional supplements | Dietary supplement | B - nutritional supplementation, C - physical activity, D - nutritional supplementation plus physical activity |
Primary outcome
Variation of fatty acids concentration
Time frame: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Plasma metabolic sample will be analyzed using a GCxGC-MS instrument for the relative and absolute quantification of small molecules in order to evaluate the impact of a lifestyle intervention including dietary supplements and physical exercise on the modulation of metabolomic signatures in eBC patients candidate to NACT.
Omega3 Index
Time frame: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Assessment of Omega-3 Index in all patients cohorts at: * baseline * pre-operatative (at the end of NACT) The omega3 index will assessed by the sum of DHA and EPA in erythrocytes expressed as a percentage of total erythrocyte fatty acid.
7 secondary outcomes
Combined lifestyle intervention
Time frame: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Lymphocyte subpopulations
Time frame: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Antitumor activity
Time frame: From T0 until surgery, approximately 6 months (according to biological subtype)
changes in health-related Quality of Life
Time frame: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: at three months after inclusion; T2: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
changes in health-related Quality of Life
Time frame: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: at three months after inclusion; T2: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
changes in health-related Quality of Life
Time frame: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: at three months after inclusion; T2: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)
Impact on treatment-related adverse events
Time frame: Evaluation will be performed before of each cycle of NACT (each cycle is 21 days). NACT is approximately 6 months, according to biological subtype.
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 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Alessandra Gennari, MD study chair
University of Piemonte Orientale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid) in people with Early Breast Cancer and Neoadjuvant Treatment, run by University of Eastern Piedmont 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 9 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 15 Apr 2025. 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 Carmen Branni, BSc (+3903213732292, carmen.branni@uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of fatty acids concentration (time frame: T0: baseline, prior to cycle 1 (each cycle is 21 days); T1: end of NACT, before surgery (NACT is approximately 6 months, according to biological subtype)). 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?
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 15 Apr 2025.