Clinical trial · Observational
Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)
Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)
- 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)
It will be conducted as an international multicenter prospective observational cohort study in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- ErbB2+ metastatic breast cancer patients
- interventionNames
- Drug: Treatment
Primary outcomes (1)
- measure
- Time to disease progression
- timeFrame
- One year
- description
- the time from the date of start of Lapatinib capecitabine treatment until date of documented disease progression by the treating physician
Secondary outcomes (2)
- measure
- Overall Response Rate
- timeFrame
- One year
- description
- the percentage of patients showing complete response (CR) and partial response (PR) to the given treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
* Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice); * Older than 18 years old; * Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer; * Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment; * Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, OR receiving standard treatment with * Lapatinib-capecitabine at conventional doses, for no longer than 10 weeks from the start of the treatment to the date of inclusion in the study; * Signed consent to participate and release information for this study.
References
Publications (0)
Data not yet available