Clinical trial · Interventional
Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer
- 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 randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine and Pyrotinib | Drug | — | UNRESOLVED |
| Capecitabine,Trastuzumab, and Pertuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Capecitabine and Pyrotinib
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: Capecitabine,Trastuzumab, and Pertuzumab
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Approximately 42 months
Secondary outcomes (5)
- measure
- Adverse Events and Serious Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * HER2 positive recurrent or metastasis breast cancer. * Patients with measurable disease are eligible. * Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1. * Adequate organ function. * Signed, written inform consent obtained prior to any study procedure. Exclusion Criteria: * History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）. * History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting. * Assessed by the investigator to be unable receive systemic chemotherapy. * History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. * Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
References
Publications (0)
Data not yet available