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A Randomized, Multicentric, Open-Label Trial to Investigate the Benefit of Adding Fasten Onco Digital Therapy Integrating a Fasting Mimicking Diet During Neoadjuvant Treatment to Standard of Care, Compared to Standard of Care Alone, in Women (Aged 18 Years or Older), With Early-Stage II/III Triple-Negative Breast Cancer (FAST-01)

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT07884721
Title field or adapter rule
{'original_value': 'A Randomized, Multicentric, Open-Label Trial to Investigate the Benefit of Adding Fasten Onco Digital Therapy Integrating a Fasting Mimicking Diet During Neoadjuvant Treatment to Standard of Care, Compared to Standard of Care Alone, in Women (Aged 18 Years or Older), With Early-Stage II/III Triple-Negative Breast Cancer (FAST-01)', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-31T23:27:30.447049+00:00
Published At
2026-10-21T00:00:00+00:00
Record Updated At
2026-10-21
Source Retrieved At
2026-10-31T22:18:22.973355+00:00
Timestamp Basis
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions
["Triple-Negative Breast Cancer (TNBC)"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-10-21", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT07884721"
protocolSection.identificationModule.officialTitle
"A Randomized, Multicentric, Open-Label Trial to Investigate the Benefit of Adding Fasten Onco Digital Therapy Integrating a Fasting Mimicking Diet During Neoadjuvant Treatment to Standard of Care, Compared to Standard of Care Alone, in Women (Aged 18 Years or Older), With Early-Stage II/III Triple-Negative Breast Cancer (FAST-01)"
protocolSection.statusModule.overallStatus
"NOT_YET_RECRUITING"
protocolSection.designModule.phases
["NA"]
protocolSection.statusModule.resultsFirstPostDateStruct
null

Study condition terms

  • Triple-Negative Breast Cancer (TNBC) (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['FASTEN Group'], 'description': "Fasten Onco is a digital medical device designed to support the implementation of a fasting-mimicking diet (FMD) during neoadjuvant treatment. The device provides a personalized nutritional program synchronized with the participant's treatment schedule, together with educational content, reminders, and guidance to support adherence. The program is prescribed and configured by a healthcare professional and is used under medical supervision.", 'name': 'Fasten Onco', 'type': 'DEVICE'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Standard of Care Group'], 'description': 'Standard neoadjuvant treatment for stage II/III triple-negative breast cancer according to the standard of care at each participating center. Treatment may include paclitaxel, carboplatin, epirubicin or doxorubicin, cyclophosphamide, and pembrolizumab, used within their approved indications. Standard neoadjuvant treatment is administered in both study groups.', 'name': 'Standard Neoadjuvant Treatment', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

  • Standard Neoadjuvant Treatment (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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