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NCT06727487: ENBI
OvS Breast: Ovarian Suppression in Breast Cancer Interventions
NA trial testing Basic recommendations in Breast Neoplasms in 30 participants. Currently enrolling.
15 April 2025
Quick facts
| Lead sponsor | Universidad Pontificia Comillas |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 15 November 2024 |
| Primary completion | 15 April 2025 |
| Estimated completion | 15 December 2025 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Basic recommendations
- Physical exercise
- Nutritional advice
- Psycho-oncological support
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
Universidad Pontificia Comillas
Who can join
Adults 18 to 45, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to compare a combined intervention based on physical exercise, nutritional control, and individualized psycho-oncological support can achieve weight control and maintain adequate body composition in premenopausal women with localized BC with ER and/or PR expression who receive aLHRH in combination with TAM or AI as part of adjuvant treatment. The study's primary objectives are to evaluate the impact of the combined intervention on weight reduction and favorable modification of body composition in terms of reduction in body fat and increase in lean mass. The secondary objectives aim to evaluate the impact of the combined intervention program on CRF, heart rate (HR), capillary lactate levels, upper and lower body strength, physical functionality, and patient-reported outcomes (PROs). (exercise level, asthenia, self-perception, anxiety and depression), blood count and biochemistry values that could be modified, nutritional situation, and side effects of treatments.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Randomized pilot study of an individualized multimodal exercise, nutrition, and behavior intervention in breast cancer patients treated with ovarian function suppression: protocol proposal for The OvS Breast ENBI Project.
Herrero López B, Castellanos Montealegre M, Soulas C, Rufrancos BA, et al · · 2025 · cited 1× · PMID 41220947 · DOI 10.3389/fonc.2025.1622622
Verify or expand the search:
- PubMed search for NCT06727487
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Universidad Pontificia Comillas trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06727487 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad Pontificia Comillas
- Last refreshed: 11 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06727487.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing