NCT07406789RecruitingPhase 2
Phase II, Prospective, Randomized, Proof-of-concept Study to Evaluate the Effects of a Personalized Dietary Intervention in Women With Advanced Gynecologic or Breast Tumors Treated With Antibody-Drug Conjugates (ADCs).
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
The objective of the study is to evaluate the effect of a personalized dietary intervention (cohort A), compared with a standard nutritional intervention based on general recommendations for following a Mediterranean diet (cohort B), in women with advanced solid tumors of gynecologic or breast origin who are receiving treatment with antibody-drug conjugates (ADCs). This intervention is exclusively nutritional and does not involve the use of any investigational drug.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 6 Feb 2026
- Start date
- Mar 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- TNC Nutrición Terapéutica S.L.
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07406789
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From Mar 2026 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous or concomitant malignant disease of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin or in situ cervical cancer are eligible for the study.
- Presence of concurrent diseases or clinical conditions that, in the investigator's judgment, may significantly interfere with participation in the study, particularly those that limit the ability to adequately use the required digital tools (APP and wearable device). Patients will not be excluded due to common comorbidities if they retain adequate cognitive functioning and digital familiarity to comply with study procedures.
Other illness
- Type 1 diabetes mellitus, metabolic diseases, and severe gastrointestinal disorders that interfere with the digestion or absorption of nutrients, as well as patients with severe renal or hepatic impairment.
- Carriers of therapeutic electronic devices: pacemakers, defibrillators, and cardiac resynchronization devices (due to potential interference caused by the wearable).
Other
- Male patient.
- BMI \<18 or \> 40 kg/m2.
- Patients with a life expectancy of less than 3 months.
- Planned participation in treatment within a double-blind clinical trial.
- Patients who, in the investigator's judgment, do not possess sufficient digital capability to comply with the study procedures.
Who the study is looking for
- Written informed consent to participate in the study, obtained prior to performing any specific procedure.
- Women aged ≥ 18 years.
- Confirmed diagnosis of advanced, incurable (stage IV or unresectable stage III) breast cancer or gynecologic cancer. This includes cancers of the breast, ovary, cervix, uterus, endometrium, fallopian tubes, vagina, or vulva.
- Participants must have received a first cycle of ADC treatment in any line of treatment.
- ECOG performance status 0-2.
- Availability of their main clinical data with the possibility of follow-up.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario 12 Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.