Clinical trial · Observational
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
NCT06076772CI-TRIAL-00070380not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer. To evaluate the risk factors for occurrence of neutropenia and treatment outcome as 2 years PFS and OS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- cases developed neutropenia Grade 0-2 with palbociclib administration
- interventionNames
- Drug: Palbociclib
- label
- 2
- description
- cases developed neutropenia Grade 3-4 with palbociclib administration
- interventionNames
- Drug: Palbociclib
Primary outcomes (3)
- measure
- Investigator will evaluate the patients and treatment characters in counts and percentage of developing high-grade neutropenia induced by palbociclib.
- timeFrame
- 2 years
- description
- Investigator will record the patients and treatment characters in counts and percentage that associated with the occurrence of high-grade neutropenia. And then will compare the characters differences in patients with and without high grade neutropenia by uninitiated and multivariate statistical analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histological pathological confirmation of primary breast cancer or metastatic disease. * Hormonal receptor-positive, HER2 negative. * Metastatic breast cancer at presentation (Den novo) or recurrent. * Patients did not receive any previous systemic therapy for metastatic disease. * Performance status (ECOG) 0-2. Exclusion Criteria: * Patient with co-morbidity * Pregnant and breast lactating women
References
Publications (6)
- BACKGROUNDKim SG, Kim MH, Park S, Kim GM, Kim JH, Kim JY, Park HS, Park S, Park BW, Kim SI, Ji JH, Jeong J, Shin K, Lee J, Kim HD, Jung KH, Sohn J. Efficacy of Limited Dose Modifications for Palbociclib-Related Grade 3 Neutropenia in Hormone Receptor-Positive Metastatic Breast Cancer. Cancer Res Treat. 2023 Oct;55(4):1198-1209. doi: 10.4143/crt.2022.1543. Epub 2023 Apr 11. PMID 37054718
- BACKGROUNDMcAndrew NP, Dickson MA, Clark AS, Troxel AB, O'Hara MH, Colameco C, Gallager M, Gramlich K, Zafman K, Vaughn D, Schwartz GK, O'Dwyer PJ, DeMichele A. Early treatment-related neutropenia predicts response to palbociclib. Br J Cancer. 2020 Sep;123(6):912-918. doi: 10.1038/s41416-020-0967-7. Epub 2020 Jul 9. PMID 32641862
- BACKGROUNDLavery L, DiSogra K, Lea J, Trufan SJ, Symanowski JT, Roberts A, Moore DC, Heeke A, Pal S. Risk factors associated with palbociclib-induced neutropenia in patients with metastatic breast cancer. Support Care Cancer. 2022 Dec;30(12):9803-9809. doi: 10.1007/s00520-022-07400-z. Epub 2022 Oct 19. PMID 36260177
- BACKGROUNDKanbayashi Y, Sakaguchi K, Ishikawa T, Takayama K, Taguchi T. Predictors for development of palbociclib-induced neutropenia in breast cancer patients as determined by ordered logistic regression analysis. Sci Rep. 2021 Oct 8;11(1):20055. doi: 10.1038/s41598-021-99504-5. PMID 34625634
- BACKGROUNDLee Y, Lee D, Seo I, Chae H, Sim SH, Lee KS, Gwak HS. Risk Factors for Palbociclib-Induced Early Developing Neutropenia in Patients with Hormone Receptor-Positive Metastatic Breast Cancer. Cancers (Basel). 2023 May 18;15(10):2810. doi: 10.3390/cancers15102810. PMID 37345147
- BACKGROUNDVazquez L, Arnaud A, Grenier J, Debourdeau P. [Patients treated with palbociclib and endocrine therapy for metastatic breast cancer: Can we predict the occurrence of severe early hematological toxicity?]. Bull Cancer. 2021 May;108(5):544-552. doi: 10.1016/j.bulcan.2021.01.007. Epub 2021 Apr 2. French.