HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Frankfurt, Germany
Status: Recruiting
Start Date
June 2013
Completion Date
September 2018
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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