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NCT05303129: PEPSI
Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 Inhibitor.
NA trial testing Blood sampling in Breast Cancer in 165 participants. Completed in 17 December 2024.
17 December 2024
Quick facts
| Lead sponsor | Centre Francois Baclesse |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 165 |
| Start date | 27 May 2022 |
| Primary completion | 17 December 2024 |
| Estimated completion | 17 December 2024 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Blood sampling — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Sponsor
Centre Francois Baclesse — full company profile →
Who can join
18 and older, female only, with Breast Cancer or Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied. We propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4/6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos / HER2-neg breast cancer. We will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4/6 inhibitor therapy in combination with hormone therapy in these patients. Specific blood tests (lymphocyte typing) will be performed during treatment with CDK4/6.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pretreatment neutrophil to lymphocyte ratio as prognostic factor in metastatic breast cancer treated with cyclin dependent kinase 4/6 inhibitors.
Rottier P, Emile G, Johnson A, Levy C, et al · · 2022 · cited 14× · PMID 36741710 · DOI 10.3389/fonc.2022.1105587
Verify or expand the search:
- PubMed search for NCT05303129
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05303129 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 Centre Francois Baclesse
- Last refreshed: 20 January 2025
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/NCT05303129.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing