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AzTrials

Breast CancerPhase 2BREAKFAST-2NCT05763992

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemoimmunotherapy and a FASTing-like Approach in the Preoperative Setting: the BREAKFAST 2 Trial

A Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Italian, multicenter, open-label, two-arm, comparative, randomized phase II study investigating if the addition of the experimental metabolic intervention consisting in cycles of Fasting-Like Approach, as administered every three weeks up to a maximum of 8 consecutive cycles, is able to increase the anticancer… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
145 participants
Where
1 siteItaly
Study dates
15 May 2023to 15 May 2026
Phase
Phase 2
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female sex
  • Age ≥ 18 and ≤ 75 years.
  • Evidence of a personally signed and dated informed consent document (ICD), signed and dated from the patient of legal representative with or without an impartial witness, indicating that the patient has been informed of all pertinent aspects of the study before enrollment
  • Willingness and ability to comply with the prescribed FLA regimen, the scheduled visits, treatment plans, laboratory tests and other procedures.
  • Histologically confirmed diagnosis of invasive TNBC candidate to neoadjuvant chemo-immunotherapy and subsequent curative surgery. On the basis of International Guidelines, TNBC is defined by absent or minimal (<1%) expression of oestrogen and progesterone receptors at IHC, and absence of HER2 protein over-expression and HER2 gene amplification, as defined as an IHC score of 0, 1+, or an IHC score of 2+ with in situ hybridization (ISH) analysis excluding HER2 gene amplification. The expression of hormone receptors (ER and PgR) and HER2 will be evaluated through immunohistochemistry (IHC), according to International Guidelines47,48
  • Availability of a formalin-fixed, paraffin-embedded (FFPE) block containing tumor tissue, or at least 7 unstained tumor slides.
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  • Patients with tumor stage T1c AND nodal stage N1-2, or tumor stage T2-4 AND nodal stage N0-2 according to TNM.
  • Presence of an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Presence of adequate bone marrow and organ function as defined by the following laboratory values:
  • ANC ≥ 1.5 x 103/l
  • platelets ≥ 100 x 103/l
  • hemoglobin ≥ 9.0 g/dl
  • calcium (corrected for serum albumin) within normal limits or ≤ grade 1 according to NCI-CTCAE version 5.0 if not clinically significant
  • potassium within the normal limits, or corrected with supplements
  • creatinine < 1.5 ULN
  • blood uric acid < 10 mg/dl
  • ALT and AST ≤ 2 x ULN
  • total bilirubin < 1.5 ULN except for patients with Gilbert syndrome who may only be included if the total bilirubin is < 3.0 x ULN or direct bilirubin < 1.5 x ULN
  • Fasting glucose ≤ 250 mg/dl.
  • Female patients of childbearing potential must agree to sexual abstinence or to use two highly effective methods of contraception throughout the study and for at least six months after the end of the FLA. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Examples of contraceptive methods with a failure rate of < 1% per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices. Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < 1% per year. Barrier methods must always be supplemented with the use of a spermicide. A patient is of childbearing potential if, in the opinion of the Investigator, she is biologically capable of having children and is sexually active.
  • Female patients are not of childbearing potential if they meet at least one of the following criteria:
  • Have undergone a documented hysterectomy and/or bilateral oophorectomy
  • Have medically confirmed ovarian failure
  • Achieved post-menopausal status, defined as: ≥ 12 months of non-therapy-induced amenorrhea or surgically sterile (absence of ovaries); in women <45 years of age FSH level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.

Who cannot join

  • Prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment, except for adequately treated basal cell or squamous skin cancer or in situ cervical cancer. Other malignancies diagnosed more than 5 years before the diagnosis of breast cancer must have been radically treated without evidence of relapse at the moment of patient enrollment in the trial.
  • Prior treatment with anthracyclines
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
  • Body mass index (BMI) < 19 kg/m2.
  • History of alcohol abuse.
  • Non-intentional weight loss ≥ 5% in the previous 3 months, unless the patient has a BMI > 22 kg/m2 and weight loss has been lower than 10% at the time of enrollment in the study; or non-intentional weight loss of ≥ 10% in the previous 3 months, unless the patient has a BMI > 25 kg/m2 and weight loss has been lower than 15% at the time of the enrollment in the study. In both cases, weight must have been stable for at least one month before study enrollment.
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  • Active pregnancy or breast feeding.
  • Known active B or C hepatitis or human immunodeficiency virus (HIV) infection, or occasional finding of active hepatitis B/C infection during screening tests before chemotherapy initiation, as defined as positive polymerase chain reaction (PCR) testing for HBV-DNA and HCV-RNA and qualitative PCR for HIV-RNA, or requiring active treatment at study enrollment.
  • Serious infections in the previous 4 weeks before the FLA initiation, including, but not limited to, potential hospitalizations for complications of infections, bacteriemia or serious pneumonitis.
  • Active autoimmune diseases requiring systemic treatments (e.g., systemic steroids or immune suppressants). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Active chronic therapy with systemic steroids at a dose ≥ 10 mg per day of prednisone or equivalent at study enrollment.
  • Diagnosis of type 1 or 2 diabetes mellitus requiring pharmacologic therapy (including, but not limited to, insulin or insulin secretagogues), with the exception of metformin. A diagnosis of type 2 diabetes mellitus not requiring pharmacological treatments, or only requiring treatment with metformin, based on the judgment of a diabetologist, is compatible with patient enrollment in the trial.
  • Anamnesis of clinically significant heart disease including:
  • angina pectoris, coronary bypass, symptomatic pericarditis, myocardial infarction in the previous 12 months from the beginning of experimental therapy;
  • congestive heart failure (NYHA III-IV).
  • Anamnesis of clinically meaningful cardiac arrhythmias, such as ventricular tachycardia, chronic atrial fibrillation, complete bundle branch block, high grade atrio-ventricular block like bi-fascicular block, type II Mobitz and third grade atrio-ventricular block, nodal arrhythmias, supra-ventricular arrhythmia.
  • Left ventricular ejection fraction lower than 50% at the cardiac scan with radionuclides or at echocardiography.
  • Previous episodes of symptomatic hypotension leading to loss of consciousness.
  • History of eating disorders (anorexia, bulimia).
  • Baseline plasma fasting glucose ≤ 60 mg/dL.
  • Medical or psychiatric comorbidities rendering the patient not candidate to the clinical trial, according to the investigator's judgement.
  • Other cardiac, liver, lung or renal comorbidities, not specified in the previous inclusion or exclusion criteria, but potentially exposing the patient to a high risk of lactic acidosis.
  • Known history of active TB (Bacillus Tuberculosis).

Trial locations and contacts

1 site in 1 country.

Claudio Vernieri, MD, PhD contact

0223903066

claudio.vernieri@istitutotumori.mi.it; claudio.vernieri@ifom.eu

Francesca Ligorio, MD contact

0223903066

francesca.ligorio@istitutotumori.mi.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

    Claudio Vernieri, claudio.vernieri@istitutotumori.mi.it

    Francesca Ligorio, francesca.ligorio@istitutotumori.mi.it

    Recruiting

Other trials in Italy

About this study

Italian, multicenter, open-label, two-arm, comparative, randomized phase II study investigating if the addition of the experimental metabolic intervention consisting in cycles of Fasting-Like Approach, as administered every three weeks up to a maximum of 8 consecutive cycles, is able to increase the anticancer activity of standard preoperative chemo-immunotherapy in patients with localized invasive Triple Negative Breast Cancer.

Read the detailed description

TNBC is the most aggressive subtype of breast cancer. TNBC patients who achieve pCR during neoadjuvant chemo-immunotherapy have significantly lower rates of disease recurrence or death. Preclinical studies indicate that combining nutrient starvation, in the form of cycles of FLA, with anthracycline- or platinum-based chemotherapy remarkably increases the therapeutic index of chemotherapy against murine and human models of breast cancer, including models of TNBC. In particular, the chemotherapy-fasting/FLA combination increases the anticancer activity of chemotherapy, while reducing treatment-related adverse events (AEs). Moreover, the FLA has demonstrated potent and desirable immunomodulatory effects both in in vivo studies and in patients with cancer, and the activation of antitumor immunity is a crucial mediator of the anticancer effects of the FLA, either alone or in combination with chemotherapy. Therefore, there is a strong biological rationale to combine cyclic FLA with ICIs in cancer therapy.

Based on these data, we hypothesize that combining the FLA with standard-of-care, preoperative, anthracycline-taxane-carboplatin chemotherapy plus Pembrolizumab can increase the rate of pCR in a population of patients with stage II-III TNBC.

This is an Italian, multicenter, open-label, two-arm, comparative, randomized phase II study. This study is designed to investigate if the addition if the experimental metabolic intervention consisting in cycles of FLA, as administered every three weeks up to a maximum of 8 consecutive cycles, is able to increase the anticancer activity of standard preoperative chemo-immunotherapy consisting of antracycline-taxane-carboplatin-based chemotherapy plus pembrolizumab in patients with treatment naïve, localized (tumor stage T1c AND nodal stage N1-2, or tumor stage T2-4 AND nodal stage N0-2) invasive Triple Negative Breast Cancer (HER2 negative, ER <1%, PgR <1%). Bilateral and/or multifocal primary tumor is allowed, as well as inflammatory breast cancer, and the tumor with the most advanced T stage should be used to assess the eligibility. If multi-focal/multi-centric disease, TNBC needs to be confirmed for each focus. The primary study endpoint is pathologic complete response (pCR).

Patients will be randomly allocated to one of the following treatment arms:

  • Arm A (control arm): 12 consecutive cycles of weekly paclitaxel plus carboplatin (PCb) combined with 4 triweekly cycles of Pembrolizumab, followed by 4 consecutive cycles of triweekly anthracycline (doxorubicin or epirubicin)-cyclophosphamide (AC or EC) chemotherapy combined with 4 triweekly cycles of Pembrolizumab. This combination treatment will be further referred to as "standard treatment".
  • Arm B (experimental arm): standard treatment in combination with up to a maximum of 8 consecutive triweekly cycles of 5-day FLA.

Enrolled patients will be randomized in a 1:1 ratio and stratified according to a) disease stage: stage II (T1N1, T2N0, T2N1, T3N0) vs. stage III (T3N1; any T4; any N2); b) patient body mass index (BMI ≥25 kg/m2 vs <25 kg/m2).

After completion of the experimental preoperative protocol, patients will undergo surgery between 14 and 28 days after the last chemotherapy administration.

After surgery, patients will receive 9 additional triweekly pembrolizumab administration at the same dosage, and regardless of the pathologic tumor response (pCR yes vs. no). After surgery, patients may receive local radiotherapy, depending on the pathological stage and according to local and international guidelines.

Being tested
Control diet (ARM A) or Fasting-Like Approach (FLA, ARM B)
Keywords
Triple Negative Breast Cancer, Neoadjuvant chemoimmunotherapy, Fasting-Like Approach, Immunometabolism, Pathologic Complete Responses (pCRs), Randomized, phase II trial
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms, Fasting, Pathologic Complete Response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control diet (ARM A) or Fasting-Like Approach (FLA, ARM B)Dietary supplement

    Each FLA cycle will consist of 5 consecutive days of a specific FLA scheme, which will be repeated with a three-week interval. The FLA will consist of a plant-based, low-calorie (about 600 Kcal on day 1; about 300 Kcal on day 2 to 5), low-protein, low-carbohydrate diet. The first FLA cycle will start two days prior to the day of first chemo-immunotherapy cycle administration and will continue for two more days after chemotherapy. In the absence of significant contraindications or severe adverse events, subsequent FLA cycles will recur with three-week intervals and will maintain the same timing with respect to chemo-immunotherapy administration.

Study groups in NCT05763992
Study groupRoleWhat they receive
Arm APlacebo comparator12 consecutive cycles of weekly paclitaxel plus carboplatin (PCb) combined with 4 triweekly cycles of Pembrolizumab, followed by 4 consecutive cycles of triweekly anthracycline (doxorubicin or epirubicin)-cyclophosphamide (AC or EC) chemotherapy combined with 4 triweekly cycles of Pembrolizumab.
Receives: Dietary Supplement: Control diet (ARM A) or Fasting-Like Approach (FLA, ARM B)
Arm BExperimentalStandard treatment (12 consecutive cycles of weekly paclitaxel plus carboplatin (PCb) combined with 4 triweekly cycles of Pembrolizumab, followed by 4 consecutive cycles of triweekly anthracycline (doxorubicin or epirubicin)-cyclophosphamide (AC or EC) chemotherapy combined with 4 triweekly cycles of Pembrolizumab) in combination with up to a maximum of 8 consecutive triweekly cycles of 5-day Fasting-Like Approach
Receives: Dietary Supplement: Control diet (ARM A) or Fasting-Like Approach (FLA, ARM B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Pathologic complete response (pCR)

    Absence of residual tumor cells in both breast tissue and axillary lymph nodes (ypT0/ypTis ypN0)

    Measured: Surgical specimen (at the time of surgery)

Secondary outcomes (12)

  1. Disease free survival (DFS)

    Time from surgery to tumor recurrence, either local or distant, or patient death from any cause, assessed up to 36 months

    Measured: Time from surgery to tumor recurrence or patient death, assessed up to 36 months

  2. Event-free survival (EFS)

    Time from the date of randomization to the first documentation of progressive disease, or patient death from any cause, assessed up to 36 months

    Measured: From the date of randomization to the first documentation of progressive disease or patient death, assessed up to 36 months

  3. Distant metastasis free survival (DMFS)

    Time from surgery to the occurrence of distant metastases or patient death from any cause, assessed up to 36 months

    Measured: From surgery to the occurrence of distant metastases or patient death, assessed up to 36 months

  4. Overall Survival (OS)

    Time from randomization to the date of death (patients alive at the time of data cut-off and analysis will be censored at their last contact date), assessed up to 60 months

    Measured: Time from randomization to the date of death, assessed up to 60 months

  5. Compliance (Dose-intensity)

    Dose of effective drug administrated per unit of time (e.g., mg/m2/week)

    Measured: From the start to the end of the neoadjuvant treatment (about 6 months)

  6. Compliance (Drug dose/time modifications)

    Percentage of patients with drug dose and/or time modifications

    Measured: From the start to the end of the neoadjuvant treatment (about 6 months)

  7. Compliance (Dietary regimen modifications)

    Percentage of patients with experimental dietary regimen modifications

    Measured: From the start to the end of the neoadjuvant treatment (about 6 months)

  8. Compliance (Withdrawals)

    Percentage of premature withdrawals

    Measured: From the start to the end of the neoadjuvant treatment (about 6 months)

  9. Safety (AE)

    Incidence, nature, severity and seriousness of AEs, according of NCI-CTCAE, version 5.0

    Measured: From the start to the end of the neoadjuvant treatment (about 6 months)

  10. Safety (Maximum toxicity grade)

    Maximum toxicity grade experienced by each patient for each specific toxicity

    Measured: From the start to the end of the neoadjuvant treatment (about 6 months)

  11. Safety (G3-G4 AEs)

    Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity

    Measured: From the start to the end of the neoadjuvant treatment (about 6 months)

  12. Safety (SAE)

    Patients with at least a SAE

    Measured: From the start to the end of the neoadjuvant treatment (about 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start15 May 2023 (estimated)
  3. Primary completion15 May 2025 (estimated)
  4. Study completion15 May 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, open-label, two-arm, comparative, randomized phase II study
Masking
None (open label)
Enrolment
145 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763992
Sponsor's protocol ID
INT214/22
Acronym
BREAKFAST-2
Status last verified
Dec 2022
First submitted
18 Jan 2023
Last updated
18 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kassam F, Enright K, Dent R, Dranitsaris G, Myers J, Flynn C, Fralick M, Kumar R, Clemons M. Survival outcomes for patients with metastatic triple-negative breast cancer: implications for clinical practice and trial design. Clin Breast Cancer. 2009 Feb;9(1):29-33. doi: 10.3816/CBC.2009.n.005.

    PubMed 19299237

  • Cortazar P, Zhang L, Untch M, Mehta K, Costantino JP, Wolmark N, Bonnefoi H, Cameron D, Gianni L, Valagussa P, Swain SM, Prowell T, Loibl S, Wickerham DL, Bogaerts J, Baselga J, Perou C, Blumenthal G, Blohmer J, Mamounas EP, Bergh J, Semiglazov V, Justice R, Eidtmann H, Paik S, Piccart M, Sridhara R, Fasching PA, Slaets L, Tang S, Gerber B, Geyer CE Jr, Pazdur R, Ditsch N, Rastogi P, Eiermann W, von Minckwitz G. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 Jul 12;384(9938):164-72. doi: 10.1016/S0140-6736(13)62422-8. Epub 2014 Feb 14.

    PubMed 24529560

  • Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.

    PubMed 25092775

  • Poggio F, Tagliamento M, Ceppi M, Bruzzone M, Conte B, Fregatti P, Punie K, de Azambuja E, Del Mastro L, Lambertini M. Adding a platinum agent to neoadjuvant chemotherapy for triple-negative breast cancer: the end of the debate. Ann Oncol. 2022 Mar;33(3):347-349. doi: 10.1016/j.annonc.2021.11.016. Epub 2021 Nov 30. No abstract available.

    PubMed 34861375

  • Cortes J, Cescon DW, Rugo HS, Nowecki Z, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Holgado E, Iwata H, Masuda N, Otero MT, Gokmen E, Loi S, Guo Z, Zhao J, Aktan G, Karantza V, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020 Dec 5;396(10265):1817-1828. doi: 10.1016/S0140-6736(20)32531-9.

    PubMed 33278935

  • Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.

    PubMed 32966830

  • Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.

    PubMed 32101663

  • Gong Y, Ji P, Yang YS, Xie S, Yu TJ, Xiao Y, Jin ML, Ma D, Guo LW, Pei YC, Chai WJ, Li DQ, Bai F, Bertucci F, Hu X, Jiang YZ, Shao ZM. Metabolic-Pathway-Based Subtyping of Triple-Negative Breast Cancer Reveals Potential Therapeutic Targets. Cell Metab. 2021 Jan 5;33(1):51-64.e9. doi: 10.1016/j.cmet.2020.10.012. Epub 2020 Nov 11.

    PubMed 33181091

  • Vernieri C, Casola S, Foiani M, Pietrantonio F, de Braud F, Longo V. Targeting Cancer Metabolism: Dietary and Pharmacologic Interventions. Cancer Discov. 2016 Dec;6(12):1315-1333. doi: 10.1158/2159-8290.CD-16-0615. Epub 2016 Nov 21.

    PubMed 27872127

  • Salvadori G, Zanardi F, Iannelli F, Lobefaro R, Vernieri C, Longo VD. Fasting-mimicking diet blocks triple-negative breast cancer and cancer stem cell escape. Cell Metab. 2021 Nov 2;33(11):2247-2259.e6. doi: 10.1016/j.cmet.2021.10.008.

    PubMed 34731655

  • Caffa I, Spagnolo V, Vernieri C, Valdemarin F, Becherini P, Wei M, Brandhorst S, Zucal C, Driehuis E, Ferrando L, Piacente F, Tagliafico A, Cilli M, Mastracci L, Vellone VG, Piazza S, Cremonini AL, Gradaschi R, Mantero C, Passalacqua M, Ballestrero A, Zoppoli G, Cea M, Arrighi A, Odetti P, Monacelli F, Salvadori G, Cortellino S, Clevers H, De Braud F, Sukkar SG, Provenzani A, Longo VD, Nencioni A. Fasting-mimicking diet and hormone therapy induce breast cancer regression. Nature. 2020 Jul;583(7817):620-624. doi: 10.1038/s41586-020-2502-7. Epub 2020 Jul 15.

    PubMed 32669709

  • Di Tano M, Raucci F, Vernieri C, Caffa I, Buono R, Fanti M, Brandhorst S, Curigliano G, Nencioni A, de Braud F, Longo VD. Synergistic effect of fasting-mimicking diet and vitamin C against KRAS mutated cancers. Nat Commun. 2020 May 11;11(1):2332. doi: 10.1038/s41467-020-16243-3.

    PubMed 32393788

  • Vernieri C, Ligorio F, Zattarin E, Rivoltini L, de Braud F. Fasting-mimicking diet plus chemotherapy in breast cancer treatment. Nat Commun. 2020 Aug 26;11(1):4274. doi: 10.1038/s41467-020-18194-1.

    PubMed 32848145

  • Vernieri C, Fuca G, Ligorio F, Huber V, Vingiani A, Iannelli F, Raimondi A, Rinchai D, Frige G, Belfiore A, Lalli L, Chiodoni C, Cancila V, Zanardi F, Ajazi A, Cortellino S, Vallacchi V, Squarcina P, Cova A, Pesce S, Frati P, Mall R, Corsetto PA, Rizzo AM, Ferraris C, Folli S, Garassino MC, Capri G, Bianchi G, Colombo MP, Minucci S, Foiani M, Longo VD, Apolone G, Torri V, Pruneri G, Bedognetti D, Rivoltini L, de Braud F. Fasting-Mimicking Diet Is Safe and Reshapes Metabolism and Antitumor Immunity in Patients with Cancer. Cancer Discov. 2022 Jan;12(1):90-107. doi: 10.1158/2159-8290.CD-21-0030. Epub 2021 Nov 17.

    PubMed 34789537

  • Ligorio F, Fuca G, Provenzano L, Lobefaro R, Zanenga L, Vingiani A, Belfiore A, Lorenzoni A, Alessi A, Pruneri G, de Braud F, Vernieri C. Exceptional tumour responses to fasting-mimicking diet combined with standard anticancer therapies: A sub-analysis of the NCT03340935 trial. Eur J Cancer. 2022 Sep;172:300-310. doi: 10.1016/j.ejca.2022.05.046. Epub 2022 Jul 8.

    PubMed 35810555

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 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 24 inclusion and 23 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 18 May 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Claudio Vernieri, MD, PhD (0223903066, claudio.vernieri@istitutotumori.mi.it; claudio.vernieri@ifom.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Pathologic complete response (pCR) (time frame: Surgical specimen (at the time of surgery)). 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 NCT05763992, which also lists 15 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 18 May 2023.

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