Clinical trial · Interventional
Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer
A Multicenter Phase II Clinical Study of Pyrotinib Combined With Dalpiciclib Combined With Letrozole in the Treatment of ER-positive and HER2-positive Advanced Breast Cancer
NCT07014410CI-TRIAL-00090891recruitingPhase 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 is a a multicenter Phase II clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in ER-positive and HER2-positive advanced breast cancer patients. The sample size is 63.
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 |
|---|---|---|---|
| pyrotinib dalpiciclib letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pyrotinib dalpiciclib letrozole
- description
- Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d and letrozole 2.5mg/d until disease progression, intolerated toxicity.
- interventionNames
- Drug: pyrotinib dalpiciclib letrozole
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- through study completion, an average of 2 year
- description
- the proportion of patients achieving complete response or partial response
Secondary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- through study completion, an average of 2 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subjects voluntarily joined the study, signed the informed consent, and had good compliance 2. Postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years 3. Patients with recurrent/metastatic breast cancer confirmed by histopathology with positive ER expression and positive HER2 expression 4. Have at least one extracranial measurable lesion that meets RECIST 1.1 criteria 5. At most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer Exclusion Criteria: 1. Subjects had untreated central nervous system metastasis 2. Bilateral breast cancer, inflammatory breast cancer, or latent breast cancer 3. Previous treatment with any CDK4/6 inhibitors 4. Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption 5. Subject has had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years or at the same time
References
Publications (0)
Data not yet available
No reference posted for this study.