Clinical trial · Interventional
Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
NCT07610720CI-TRIAL-00112870recruitingPhase 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)
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.
Conditions
Conditions (2)
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/Metastatic Breast Cancer | — | UNRESOLVED | — |
| HER2-Positive Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dalpiciclib | Drug | — | UNRESOLVED |
| Endocrine Therapy 1 | Drug | Hormone Therapy | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Pyrotinib | Drug | Pyrotinib | ALIAS |
| Trastuzumab (Herceptin) | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib
- interventionNames
- Drug: Dalpiciclib
- Drug: Trastuzumab (Herceptin)
- Drug: Pertuzumab
- Drug: Pyrotinib
- Drug: Endocrine Therapy 1
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
- description
- Time from enrollment to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first
Secondary outcomes (5)
- measure
- Objective Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer. 2. Hormone receptor (HR)-positive and HER2-positive. 3. Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy. 4. ECOG Performance Status: 0-1. Exclusion Criteria: 1. Symptomatic active brain metastases or extensive leptomeningeal metastases. 2. History of Grade 3 or 4 allergic reaction related to the study drugs. 3. Currently receiving other anti-tumor therapies.
References
Publications (0)
Data not yet available
No reference posted for this study.