Clinical trial · Interventional
Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
A Multicenter, Single Arm, Prospective Phase II Clinical Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
NCT05979220CI-TRIAL-00068634not yet recruitingPhase 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)
This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalpiciclib combined with Letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dalpiciclib combined with Letrozole
- description
- Dalpiciclib combined with Letrozole,28 days as one cycle. 1. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. 2. Letrozole: 2.5mg, p.o., once a day, continuous administration.
- interventionNames
- Drug: Dalpiciclib combined with Letrozole
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Estimated up to 23 months
- description
- The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.
Secondary outcomes (1)
- measure
- Progression Free Survival 2(PFS2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer. 2. Age: 18 - 75 years old 3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~1 4. Functions of liver and kidney is normal 5. Agreed to take contraceptive measures during treatment Exclusion Criteria: 1. Confirmed diagnosis of HER2 positive disease. 2. Central nervous system metastasis 3. Patients who received prior treatment with any CDK4/6 inhibitor. 4. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention； 5. Researchers believe that is not suitable for the study
References
Publications (0)
Data not yet available
No reference posted for this study.