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A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate assessed by RECIST criteria | clinical benefit rate (CBR): defined as the percentage of patients who achieved an objective response (CR or PR) or tumor stabilization for at least 24 weeks or more during the period of treatment with the combination TL. This variable will be assessed by RECIST v 1.1 | Up to 24 weeks from the first clinical response rate assessment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib | The progression will be evaluated by RECIST v 1.1. | Up to one year from the last dose of TL |
| To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HER2 positive metastatic breast cancer who progressed to antiHER2 therapy with trastuzumab and / or lapatinib for the metastasic disease and that between January 2005 and December 2011, began treatment with the combination of trastuzumab and lapatinib (TL).
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| Name | Affiliation | Role |
|---|---|---|
| Joaquin Gávila, MD | Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barcelona | Spain | |||||
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clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks |
| Up to 24 weeks from the last dose of TL |
| To compare the time to progression of different subpopulations according to the biological characteristics of the tumor. | The progression will be evaluated by RECIST v 1.1. | Up to one year from the last dose of TL |
| To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit | Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4 | Up to one year from the last dose of TL |
| Córdoba |
| Spain |
| Girona | Spain |
| Jaén | Spain |
| Madrid | Spain |
| Pamplona | Spain |
| Salamanca | Spain |
| Santiago de Compostela | Spain |
| Seville | Spain |
| Valencia | Spain |
| Zaragoza | Spain |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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