Clinical trial · Interventional
The Resistance and Immune Response to Palbociclib in Breast Cancer
Prospective Longitudinal Biomarker Study of Acquired Resistance and Immune Response to Palbociclib in Breast Cancer
NCT03401359CI-TRIAL-00031200unknownN/AClinicalTrials.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)
The investigators propose to conduct a biomarker and molecular profiling study in longitudinally paired tumor biopsies and serum from patients with Hormone Receptor positive (HR+) metastatic Breast Cancer (BC) treated with Palbociclib in combination with endocrine therapies.
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 |
|---|---|---|---|
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tissue biopsy, blood sample | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Biomarker of palbociclib in metastatic breast cancer
- timeFrame
- 24.8 months (median progression free survival in palbociclib plus letrozole treatment (according to PALOMA-2 trial)
- description
- Biomarker of acquired resistance and immune response to palbociclib in metastatic breast cancer from whole exome sequencing, RNASeq, circulating tumor DNA and flow cytometry.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Hormone receptor positive, metastatic breast cancer * Treated by palbociclib with endocrine therapy Exclusion Criteria: * Hormone receptor negative breast cancer * Treated without palbociclib * Refuse and withdrawal to this study
References
Publications (1)
- DERIVEDPark YH, Im SA, Park K, Wen J, Lee KH, Choi YL, Lee WC, Min A, Bonato V, Park S, Ram S, Lee DW, Kim JY, Lee SK, Lee WW, Lee J, Kim M, Kim HS, Weinrich SL, Ryu HS, Kim TY, Dann S, Kim YJ, Fernandez DR, Koh J, Wang S, Park SY, Deng S, Powell E, Ravi RK, Bienkowska J, Rejto PA, Park WY, Kan Z. Longitudinal multi-omics study of palbociclib resistance in HR-positive/HER2-negative metastatic breast cancer. Genome Med. 2023 Jul 20;15(1):55. doi: 10.1186/s13073-023-01201-7. PMID 37475004