Clinical trial · Observational
Role of Early Versus Late Switch to Lapatinib-Capecitabine
Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO1) - Brazil
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was terminated because the National Ethics Committee has not approved the protocol.
Summary
Brief summary (as posted)
The study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all Brazilian States, 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 (2)
- label
- Patients on second line treatment
- description
- Patients treated with Lapatinib-capecitabine immediately after first Trastuzumab-containing regimen progression
- interventionNames
- Drug: Treatment
- label
- Patients on third or more lines treatment
- description
- Patients treated with Lapatinib-capecitabine after 2 or more lines of treatment after first Trastuzumab-containing regimen progression
- interventionNames
- Drug: Treatment
Primary outcomes (1)
- measure
- Time to disease progression (TTP)
- timeFrame
- One year
- description
- Time from the date of start of Lapatinib-capecitabine treatment until date of documented disease progression by the treating physician, determined by clinical and/or radiological assessment
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, in the community setting; * Signed consent to participate and release information for this study.
References
Publications (0)
Data not yet available