PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study
NCT ID: NCT04644406
Last Updated: 2020-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-12-31
2023-06-30
Brief Summary
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Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab.
A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines.
PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Efficacy of the Pertuzumab-Trastuzumab combination
The efficacy of the pertuzumab in combination with one of the biosimilars of Trastuzumab will be estimated by measuring the PFS at 6 months after the beginning of the treatment.
Eligibility Criteria
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Inclusion Criteria
WHO Performance status 0-2 Measurable or non-measurable (but radiologically evaluable) disease as per modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Adequate cardia function at baseline defined by a left ventricular ejection fraction of 50% or more within 2 months before treatment start
Adequate baseline organ function, evidenced by the following laboratory results within 2 months before treatment start:
Hemoglobin ≥ 9 g/dL Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Total bilirubin ≤ 1.5 upper limit of normal (ULN), or total bilirubin ≤ 3.0 × ULN in patients with documented Gilbert's Syndrome.
Glomerular Filtration Rate (GFR) ≥ 30 ml/min according to MDRD formula or CKD-EPI formula or Cockcroft and Gault formula SGOT (AST), SGPT (ALT) and alkaline phosphatase ≤ 5 × ULN Patient's consent to data collection
Exclusion Criteria
History of allergic reactions attributed to compounds of chemical or biological composition similar to trastuzumab, pertuzumab, or to chemotherapy components Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including known HIV, active hepatitis B and/or hepatitis C infection), symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or uncontrolled diabetes
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Centre de lutte contre le Cancer JEAN PERRIN, CLERMONT-FERRAND
Clermont-Ferrand, , France
Hôpital Privé Drome Ardèche
Guilherand-Granges, , France
CHU Limoges
Limoges, , France
Hospices Civils de LYon
Lyon, , France
Hôpital Tenon, AP-HP
Paris, , France
CHU Poitiers
Poitiers, , France
Countries
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Central Contacts
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Other Identifiers
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69HCL19_0593
Identifier Type: -
Identifier Source: org_study_id