Clinical trial · Observational
Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer
Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer: a Multi-center, Real-world Study
NCT06926088CI-TRIAL-00088501CAMELIAactive not 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)
Exploring the Impact of body mass index on the efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy in advanced breast cancer.
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 |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- BMI \< 25.0 kg/m²
- interventionNames
- Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety
- label
- Group 2
- description
- BMI ≥ 25.0 kg/m²
- interventionNames
- Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age and above; * Women of any menstrual status; * Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable; * Patients with histological pathology that is clearly HR-positive/HER2-negative breast cancer, or if there is metastatic pathology, the histological pathology of the metastatic foci shall prevail. (Those with ER intensity \>1% cellular nuclear staining) * Patients have at least 3 more fully documented medical records at the enrolled centre, including at least 1 inpatient record. Exclusion Criteria: * CDK4/6 inhibitors as neoadjuvant or adjuvant therapy; * Significantly missing diagnostic and treatment data from patients' medical records; * Participation in other clinical trials before and during the data collection period.
References
Publications (0)
Data not yet available
No reference posted for this study.