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The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program
This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.
The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab | Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program | ||
| Trastuzumab emtansine | Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival. | The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive | Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival. | The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features). | Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months) |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include a cohort of approximately 700 adult patients from the Spain with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early access program. The decision to initiate use of Trastuzumab emtansine (T-DM1) and Pertuzumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Belén Ruiz-Antorán, PhD | Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puerta de Hierro University Hospital | Madrid | 28222 | Spain |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Best overall response rate | Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record | Through study completion, an average of 4 year |
| Duration of response (DOR) | The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first. At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete. | Through study completion, an average of 4 year |
| Time to treatment failure | Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months) |
| Time to Objective Response | The time from start of treatment to the date of the first confirmed response (evaluated for responders only) | Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months) |
| Time to change treatment | Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months) |
| Time to next treatment | Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months) |
| All suspected Grade 3/4/5 adverse reactions | Through study completion, an average of 4 year |
| Adverse events of special interest to anti HER2 Mab (AESI) |
| Through study completion, an average of 4 year |
| AEs of scientific interest |
| Through study completion, an average of 4 year |
| D017437 |
| Skin and Connective Tissue Diseases |