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This observational study will evaluate the efficacy, safety and patient reported quality of life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in patients with HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable) who relapsed after completed adjuvant Herceptin therapy. Additionally, information on selection criteria of breast cancer patients treated first-line with Perjeta, Herceptin and chemotherapy and their treatment duration will be collected and analyzed. Data will be collected from eligible patients for up to 20 months of treatment and 24 months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Median progression-free survival in routine clinical practice | approximately 7.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration | approximately 7.5 years | |
| Clinical/demographic patients characteristics at initiation of treatment | approximately 7.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients with HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable)who relapsed after adjuvant Herceptin therapy, with indication for treatment with Perjeta in combination with Herceptin
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGAPLESION Markus-Krankenhaus | Frankfurt | 60431 | Germany |
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| Safety: Incidence of adverse events | approximately 7.5 years |
| Patient reported outcome: Quality of life (FACT B questionnaire) | approximately 7.5 years |
| 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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