HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy
Completed
- Conditions
- Breast Cancer
- Registration Number
- NCT01777958
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 135
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median progression-free survival in routine clinical practice approximately 7.5 years
- Secondary Outcome Measures
Name Time Method 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 Safety: Incidence of adverse events approximately 7.5 years Patient reported outcome: Quality of life (FACT B questionnaire) approximately 7.5 years
Trial Locations
- Locations (1)
AGAPLESION Markus-Krankenhaus
🇩🇪Frankfurt, Germany