Clinical trial · Interventional
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
NCT06341894CI-TRIAL-00075609recruitingPhase 2ClinicalTrials.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 investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early 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 |
|---|---|---|---|
| Early Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalpiciclib | Drug | — | UNRESOLVED |
| Endocrine therapy | Drug | Hormone Therapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Dalpiciclib and endocrine therapy
- interventionNames
- Drug: Dalpiciclib
- Drug: Endocrine therapy
Primary outcomes (1)
- measure
- invasive Disease-free Survival (iDFS)
- timeFrame
- From enrollment until time of events up to 3 years
- description
- Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause
Secondary outcomes (2)
- measure
- Disease-free Survival (DFS)
- timeFrame
- From enrollment until time of events up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is ≥ 18 years-old * Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause) * Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%) * Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0 * Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion * From operation to enrollment should not exceed 12 months * Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: * metastatic disease (Stage IV) or inflammatory breast cancer * Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. * Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); * A history of allergy to the drugs in this study； * Unable or unwilling to swallow tablets * History of gastrointestinal disease with diarrhea as the major symptom.
References
Publications (0)
Data not yet available
No reference posted for this study.