- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01777958
HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy
December 10, 2020 updated by: Hoffmann-La Roche
Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
135
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Frankfurt, Germany, 60431
- AGAPLESION Markus-Krankenhaus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Median progression-free survival in routine clinical practice
Time Frame: approximately 7.5 years
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approximately 7.5 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration
Time Frame: approximately 7.5 years
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approximately 7.5 years
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Clinical/demographic patients characteristics at initiation of treatment
Time Frame: approximately 7.5 years
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approximately 7.5 years
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Safety: Incidence of adverse events
Time Frame: approximately 7.5 years
|
approximately 7.5 years
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Patient reported outcome: Quality of life (FACT B questionnaire)
Time Frame: approximately 7.5 years
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approximately 7.5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 14, 2013
Primary Completion (Actual)
November 25, 2020
Study Completion (Actual)
November 25, 2020
Study Registration Dates
First Submitted
January 25, 2013
First Submitted That Met QC Criteria
January 25, 2013
First Posted (Estimate)
January 29, 2013
Study Record Updates
Last Update Posted (Actual)
December 14, 2020
Last Update Submitted That Met QC Criteria
December 10, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML28750
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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