Clinical trial · Interventional
Pyrotinib Plus Fulvestrant in Patients With HR+/HER2+ Metastatic Breast Cancer (Pyrotinib+Fulvestrant )
Pyrotinib Plus Fulvestrant in Patients HR+/HER2+ Metastatic Breast Cancer : a Prospective, Single-arm, Single-center Study
NCT04033172CI-TRIAL-00039722PyrotinibunknownPhase 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)
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, single-center clinical study of pyrotinib plus fulvestrant as the therapy HR+/HER2+ metastatic 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyrotinib Plus Fulvestrant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pyrotinib plus Fulvestrant
- interventionNames
- Drug: Pyrotinib Plus Fulvestrant
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- Estimated up to 1 year
- description
- Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.
Secondary outcomes (2)
- measure
- OS (overall survival)
- timeFrame
- Estimated up to 1 year
- description
- Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women aged 18-75 years old; HR positive and HER2 positive (immunohistochemistry or FISH test confirmed). 2. ECOG score ≤ 2, expected survival ≥ 3 months. 3. Histology or cytology confirmed as breast cancer. 4. Prior to trastuzumab and endocrine therapy and progression/recurrence. 5. At least one RECIST 1.1 defined measurable lesions. 6. Normal function of major organs. Exclusion Criteria: 1. pregnant or lactating women 2. Patients who have relapsed or progressed within 12 months of end of adjuvant or neoadjuvant therapy, including chemotherapy, target therapy (eg lapatinib， trastuzumab), or other anti-tumor therapy. Except for endocrine therapy. 3. Severe chronic gastrointestinal diseases with diarrhea as the main symptom (such as Crohn's disease, malabsorption, or ≥2 grade diarrhea caused by any cause at baseline). 4. Rapid progress of organ invasion (such as liver and lung disease greater than 1/2 organ area or liver dysfunction, etc.) 5. Patients with central nervous system disorders or mental disorders 6. Bone metastasis lesions only, no other measurable lesions. 7. Hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg) without ideal control. 8. Uncontrolled heart disease. 9. Have congenital long or short QT syndrome or have a family history or personal history of Brugada syndrome. 10. Uncontrolled rain metastasis.
References
Publications (0)
Data not yet available
No reference posted for this study.