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Triple-negative Breast CancerPhase 2BREAKFASTNCT04248998

Calorie Restriction With or Without Metformin in Triple Negative Breast Cancer

A Phase 2 study testing Fasting-mimicking diet, Metformin and Preoperative chemotherapy in people with 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Glucose starvation and metformin have synergistic antitumor effects that are mediated through the concomitant inhibition of glycolysis and mitochondrial oxidative phosphorylation. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
Fasting-mimicking diet, Metformin and Preoperative chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
5 May 2020to 1 May 2024
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

  • Patients eligible for inclusion in this study must meet all of the following criteria:
  • Female sex
  • Age ≥ 18 and ≤ 75 years.
  • Evidence of a personally signed and dated informed consent document (ICD) indicating that the patient has been informed of all pertinent aspects of the study before enrollment
  • Willingness and ability to comply with the prescribed FMD regimen, metformin intake, the scheduled visits, treatment plans, laboratory tests and other procedures.
  • Histologically confirmed diagnosis of invasive TNBC candidate to neoadjuvant chemotherapy 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 over-expression or 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.
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  • Patients with localized disease (clinical stage I-III according to TNM). Patients with Stage I TNBC will be included only if the primary tumor is at least 10 mm in greatest dimension (clinical T1c as determined through baseline MRI assessment).
  • 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 FMD. 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) and have a serum FSH level within the laboratory's reference range for postmenopausal females.

Who cannot join

  • Patients eligible for this study must not meet any of the following criteria:
  • Prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment.
  • Prior treatment with anthracyclines
  • Diagnosis of other malignancies in advanced stages (unresectable, locally advanced or metastatic), or that required systemic (neo)adjuvant chemotherapy in the previous 5 years. 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.
  • Body mass index (BMI) < 20 kg/m2.
  • History of alcohol abuse.
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  • 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 patients 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.
  • 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 FMD 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).
  • Active chronic therapy with systemic steroids at a dose ≥ 10 mg per day of prednisone or equivalent at study enrollment.
  • Known recent diagnosis of hypothyroidism requiring systemic replacement hormonal therapy and without stabilization of hormonal profile (fT3, fT4 and TSH within the normal range).
  • Diagnosis of type 1 or 2 diabetes mellitus requiring pharmacologic therapy (including, but not limited to, insulin, secretagogues and metformin). A diagnosis of type 2 diabetes mellitus not requiring pharmacological treatments based on the judgment of a diabetologist, is compatible with patient enrollment in the trial.
  • Active gastric or intestinal ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small intestine resection.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133

Other trials in Italy

About this study

Official title: Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTing Plus/Minus Metformin in the Preoperative Setting: the BREAKFAST Trial

Glucose starvation and metformin have synergistic antitumor effects that are mediated through the concomitant inhibition of glycolysis and mitochondrial oxidative phosphorylation. The BREAKFAST trial will evaluate the antitumor activity of combining cyclic fasting-mimicking diet (FMD), which reproduces the in vitro effects of glucose starvation, plus/minus metformin with standard preperative anthracycline-taxane chemotherapy in patients with stage I-III TNBC

Read the detailed description

Triple-negative breast cancer (TNBC) is the most aggressive breast cancer subtype, and is associated with the lowest cure rates in the limited-stage disease setting, as well as with the lowest overall survival in the metastatic setting. Preclinical studies indicate that cycles of fasting or calorie-restricted, low-carbohydrate, low-protein diets, also known as fasting-mimicking diets (FMDs), have synergistic cytotoxic effects when combined with chemotherapy agents, such as doxorubicin or cisplatin, in several in vitro and in vivo tumor models, including murine TNBC models. More recently, intermittent fasting has demonstrated highly synergistic antitumor effects when combined with metformin; of note, these effects are mediated through the concomitant inhibition of glycolysis (via fasting-induced hypoglycemia) and metformin-induced inhibition of mitochondrial oxidative phosphorylation (OXPHOS). Finally, small reports published so far indicate that cyclic fasting and FMDs are well tolerated in cancer patients, and can be safety combined with standard antitumor treatments.

Based on these data, the BREAKFAST trial was designed to investigate the antitumor activity of cyclic FMD, alone or in combination with metformin, in patients with localized TNBC. In this study, 90 patients with stage I-III TNBC will be randomized in a 1:1 ratio to receive approximately 6 months of standard preoperative anthracycline plus taxane chemotherapy in combination with eight triweekly cycles of 5-day FMD (Arm A), or the same chemotherapy-FMD regimen plus daily metformin (Arm B). The primary objective of the study is to demonstrate that one or both experimental treatments increase the rate of pCR from 45% (historical data) to 65%

Being tested
Fasting-mimicking diet, Metformin, Preoperative chemotherapy
Keywords
Triple-negative breast cancer, Fasting-Mimicking Diet, Metformin, Tumor Metabolism, Cytotoxic Chemotherapy
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • Fasting-mimicking dietDietary supplement

    Cyclic, 5-day, calorie-restricted (600 KCal on day 1; 300 KCal on days 2-5), low-carbohydrate, low protein diet every three weeks

  • MetforminDrug

    Also called Metforal

    Metformin 850 mg twice a day

  • Preoperative chemotherapyDrug

    Also called doxorubicin+cyclophosphamide and paclitaxel

    Chemotherapy will consist of:

    • four triweekly cycles of doxorubicin 60 mg/mq plus cyclophosphamide 600 mg/mq, followed by
    • twelve consecutive cycles of weekly paclitaxel 80 mg/mq
Study groups in NCT04248998
Study groupRoleWhat they receive
Chemotherapy plus Fasting-Mimicking Diet (FMD)ExperimentalExperimental Arm A will consist of 6 months of standard anthracycline-taxane preoperative chemotherapy in combination with triweekly cycles of 5-day FMD. Chemotherapy will consist of: * four triweekly cycles of doxorubicin 60 mg/mq plus cyclophosphamide 600 mg/mq, followed by * twelve consecutive cycles of weekly paclitaxel 80 mg/mq The FMD will consist of a triweekly 5-day regimen of a plant-based, calorie-restricted (600 KCal on day 1; 300 KCal on days 2-5), low-carbohydrate, low-protein diet. The FMD will be repeated up to a maximum of eight consecutive cycles.
Receives: Dietary Supplement: Fasting-mimicking diet; Drug: Preoperative chemotherapy
Fasting-mimicking diet plus metformin plus chemotherapyExperimentalExperimental Arm B will consist of 6 months of standard anthracycline-taxane preoperative chemotherapy in combination with triweekly cycles of 5-day FMD and daily metformin Chemotherapy will consist of: * four triweekly cycles of doxorubicin 60 mg/mq plus cyclophosphamide 600 mg/mq, followed by * twelve consecutive cycles of weekly paclitaxel 80 mg/mq The FMD will consist of a triweekly 5-day regimen of a plant-based, calorie-restricted (600 KCal on day 1; 300 KCal on days 2-5), low-carbohydrate, low-protein diet. The FMD will be repeated up to a maximum of eight consecutive cycles. Metformin will be administered at an initial dosage of 850 mg/dya, and then escalated to the maximum dosage of 1700/day (two 850 mg tablets) if well tolerated. Metformin will be interrupted 7 days before surgery.
Receives: Dietary Supplement: Fasting-mimicking diet; Drug: Metformin; Drug: Preoperative chemotherapy

What is being measured

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

  1. pCR rate

    Rate of pathologic complete responses (pCRs)

    Measured: 36 months

Secondary outcomes (19)

  1. Severe adverse events

    Incidence of severe (grade 3 or 4) adverse events according to CTCAE v 5.0

    Measured: 36 months

  2. Safety of the experimental treatments

    Incidence of treatment-related adverse events (AEs)

    Measured: 36 months

  3. Compliance with the experimental treatment

    Patients' ability to adhere to the prescribed FMD regimen and pharmacological treatment according to the analysis of daily food diaries and diaries related to metformin intake

    Measured: 36 months

  4. RFS

    Relapse-free survival

    Measured: 60 months

  5. DMFS

    Distant metastasis-free survival

    Measured: 60 months

  6. OS

    Overall Survival

    Measured: 60 months

  7. Short-term modifications of plasma glycemia (mg/dl)

    Short-term modifications of plasma glucose levels, as defined as changes in peripheral blood venous plasma glucose concentration before and after each FMD cycle

    Measured: 30 months

  8. Long-term modifications of plasma glycemia (mg/dl)

    Long-term modifications of plasma glucose concentration, as defined as changes in peripheral blood venous plasma glucose concentration measured before consecutive FMD cycles

    Measured: 30 months

  9. Short-term modifications of serum insulin concentration (µU/ml)

    Short-term modifications of serum insulin concentration, as defined as changes in peripheral blood venous serum insulin concentration before and after each FMD cycle

    Measured: 30 months

  10. Long-term modifications of serum insulin concentration (µU/ml)

    Long-term modifications of serum insulin concentration, as defined as changes in peripheral blood venous serum insulin concentration measured before consecutive FMD cycles

    Measured: 30 months

  11. Short-term modifications of serum IGF-1 concentration (ng/ml)

    Short-term modifications of serum IGF-1 concentration, as defined as changes in peripheral blood venous serum IGF-1 concentration before and after each FMD cycle

    Measured: 30 months

  12. Long-term modifications ofserum IGF-1 concentration (ng/ml)

    Long-term modifications of blood IGF-1 concentration, as defined as changes in serum IGF-1 concentration measured before consecutive FMD cycles

    Measured: 30 months

  13. Short-term modifications of blood lipid profile by UPLC-MS and HPLC-ELDS

    Short-term modifications of blood lipid profile, as defined as changes in plasma lipids before and after individual FMD cycles

    Measured: 30 months

  14. Long-term modifications of blood lipid profile by UPLC-MS and HPLC-ELDS

    Long-term modifications of blood lipid profile, as defined as changes in plasma lipids assessed before consecutive FMD cycles

    Measured: 30 months

  15. Clinical tumor response

    To estimate clinical tumor responses, as assessed through Magnetic Resonance Imaging (MRI) evaluations according to RECIST 1.1 criteria before surgery

    Measured: 30 months

  16. Gene expression profiles

    To correlate baseline metabolic gene expression, as assessed through RNA-seq analysis, with patient probability to achieve a pCR. In particular, the expression of genes encoding for catalytic, regulatory and scaffolding subunits of PP2A will be evaluated.

    Measured: 36 months

  17. Mutational analyses

    To correlate mutational tumor profiles, as assessed through whole-genome sequencing analysis, with patient probability to achieve a pCR. In particular, the expression of genes encoding for catalytic, regulatory and scaffolding subunits of PP2A will be evaluated.

    Measured: 36 months

  18. Short-term modifications of plasma amino acid profile by UPLC-QDa Mass detector system (Waters)

    Short-term modifications of plasma amino acid profile, as defined as changes in plasma amino acids before and after individual FMD cycles

    Measured: 30 months

  19. Long-term modifications of plasma amino acid profile by UPLC-QDa Mass detector system (Waters)

    Long-term modifications of plasma amino acid profile, as defined as changes in plasma amino acids assessed before consecutive FMD cycles

    Measured: 30 months

Timeline

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

  1. First posted30 Jan 2020
  2. Study start5 May 2020
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 May 2024 (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
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248998
Sponsor's protocol ID
INT 192/19
Other IDs
2019-003093-13, 2019
Acronym
BREAKFAST
Status last verified
Jan 2023
First submitted
27 Jan 2020
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Ferlay J, Colombet M, Soerjomataram I, Dyba T, Randi G, Bettio M, Gavin A, Visser O, Bray F. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018 Nov;103:356-387. doi: 10.1016/j.ejca.2018.07.005. Epub 2018 Aug 9.

    PubMed 30100160

  • Iqbal J, Ginsburg O, Rochon PA, Sun P, Narod SA. Differences in breast cancer stage at diagnosis and cancer-specific survival by race and ethnicity in the United States. JAMA. 2015 Jan 13;313(2):165-73. doi: 10.1001/jama.2014.17322.

    PubMed 25585328

  • 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

  • Gobbini E, Ezzalfani M, Dieras V, Bachelot T, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Cleaud AL, Robain M, Courtinard C, Cailliot C, Perol D, Delaloge S. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer. 2018 Jun;96:17-24. doi: 10.1016/j.ejca.2018.03.015. Epub 2018 Apr 13.

    PubMed 29660596

  • Park S, Koo JS, Kim MS, Park HS, Lee JS, Lee JS, Kim SI, Park BW. Characteristics and outcomes according to molecular subtypes of breast cancer as classified by a panel of four biomarkers using immunohistochemistry. Breast. 2012 Feb;21(1):50-7. doi: 10.1016/j.breast.2011.07.008. Epub 2011 Aug 23.

    PubMed 21865043

  • Lehmann BD, Bauer JA, Chen X, Sanders ME, Chakravarthy AB, Shyr Y, Pietenpol JA. Identification of human triple-negative breast cancer subtypes and preclinical models for selection of targeted therapies. J Clin Invest. 2011 Jul;121(7):2750-67. doi: 10.1172/JCI45014.

    PubMed 21633166

  • Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Trial Investigators. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018 Nov 29;379(22):2108-2121. doi: 10.1056/NEJMoa1809615. Epub 2018 Oct 20.

    PubMed 30345906

  • Sharma P, Lopez-Tarruella S, Garcia-Saenz JA, Khan QJ, Gomez HL, Prat A, Moreno F, Jerez-Gilarranz Y, Barnadas A, Picornell AC, Monte-Millan MD, Gonzalez-Rivera M, Massarrah T, Pelaez-Lorenzo B, Palomero MI, Gonzalez Del Val R, Cortes J, Fuentes-Rivera H, Morales DB, Marquez-Rodas I, Perou CM, Lehn C, Wang YY, Klemp JR, Mammen JV, Wagner JL, Amin AL, O'Dea AP, Heldstab J, Jensen RA, Kimler BF, Godwin AK, Martin M. Pathological Response and Survival in Triple-Negative Breast Cancer Following Neoadjuvant Carboplatin plus Docetaxel. Clin Cancer Res. 2018 Dec 1;24(23):5820-5829. doi: 10.1158/1078-0432.CCR-18-0585. Epub 2018 Jul 30.

    PubMed 30061361

  • Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. doi: 10.1038/s41591-018-0009-7. Epub 2018 Apr 30.

    PubMed 29713086

  • O'Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, Neubauer M, Robert N, Hellerstedt B, Saleh M, Richards P, Specht JM, Yardley DA, Carlson RW, Finn RS, Charpentier E, Garcia-Ribas I, Winer EP. Phase III study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer. J Clin Oncol. 2014 Dec 1;32(34):3840-7. doi: 10.1200/JCO.2014.55.2984. Epub 2014 Oct 27.

    PubMed 25349301

  • Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, Mayer EL, Naughton M, Toppmeyer D, Carey LA, Perez EA, Hudis C, Winer EP. Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance). J Clin Oncol. 2015 Jul 20;33(21):2361-9. doi: 10.1200/JCO.2014.59.5298. Epub 2015 Jun 8.

    PubMed 26056183

  • Yardley DA, Coleman R, Conte P, Cortes J, Brufsky A, Shtivelband M, Young R, Bengala C, Ali H, Eakel J, Schneeweiss A, de la Cruz-Merino L, Wilks S, O'Shaughnessy J, Gluck S, Li H, Miller J, Barton D, Harbeck N; tnAcity investigators. nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial. Ann Oncol. 2018 Aug 1;29(8):1763-1770. doi: 10.1093/annonc/mdy201.

    PubMed 29878040

  • Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109.

    PubMed 17438091

  • Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235.

    PubMed 18258986

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fasting-mimicking diet, Metformin and Preoperative chemotherapy in people with 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 24 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 Jan 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR rate (time frame: 36 months). 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 NCT04248998, which also lists 42 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 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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