Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)
Inclusion Criteria:
- Female adult patients, >/= 18 years of age
- HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable)
relapsing after completed adjuvant Herceptin therapy
- Indication for first-line treatment with Perjeta in combination with Herceptin and
chemotherapy according to the Summary of Product Characteristics
- Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a
potentially curable setting); additional upfront neoadjuvant Herceptin therapy is
allowed
- No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally
recurrent, inoperable) HER2-positive breast cancer
Exclusion Criteria:
- Pregnant or breastfeeding women
- Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the
Summary of Product Characteristics
- No Herceptin treatment for early breast cancer in the adjuvant setting
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Median progression-free survival in routine clinical practice
Outcome Time Frame:
approximately 7.5 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
to: be added
Study ID:
ML28750
NCT ID:
NCT01777958
Start Date:
March 2013
Completion Date:
November 2020
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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